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Trial registered on ANZCTR


Registration number
ACTRN12619000816156
Ethics application status
Approved
Date submitted
8/05/2019
Date registered
4/06/2019
Date last updated
14/02/2020
Date data sharing statement initially provided
4/06/2019
Date results information initially provided
14/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomized, Double-Masked (Sponsor-Open), Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Escalating Single Doses and Multiple Ascending Doses of STG-001 in Healthy Subjects
Scientific title
A Randomized, Double-Masked (Sponsor-Open), Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Escalating Single Doses and Multiple Ascending Doses of STG-001 in Healthy Subjects
Secondary ID [1] 298095 0
Nil
Universal Trial Number (UTN)
Trial acronym
STG-001-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stargardt’s Disease 312608 0
Condition category
Condition code
Eye 311116 311116 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: STG-001
Administration: Oral capsule
Part 1: Single Ascending Dose (SAD) study
Cohort 1 Fasted: STG-001 6 active (1 at 0.2 and 5 at 1 mg) and 2 placebo
Cohort 2 Fasted: STG-001 5mg (6 active, 2 placebo)
Cohort 3 Fasted and Fed : STG-001 10mg (6 active, 2 placebo)
Cohort Fasted 4: STG-001 20mg (6 active, 2 placebo)
Cohort Fasted 5: STG-001 40mg (6 active, 2 placebo)
Optional Cohort Fasted 9: STG-001 80mg (6active, 2 placebo)
The Fed period will be conducted in Cohort 3 after a washout period of >=28 days and, based on prior SAD data, dose of STG-001 will be determined to be studied under fed conditions.

Part 2: (Multiple Ascending Dose) MAD Study (STG-001 starting dose to be confirmed based on SAD results and subsequent ascending dose to be determined by study investigator based on safety and PK data,). IP will be administered once daily for 7 days.
Cohort 6 Fasted: STG-001 'X' mg (7 active and 2 placebo)
Cohort 7 Fasted: STG-001 'Y' mg (7 active and 2 placebo)
cohort 8 Fasted: STG-001 'Z' mg (7 active and 2 placebo)
Optional cohort 10 Fasted: STG-001 'A' mg (7 active and 2 placebo)

New participants will be enrolled in each cohort. In cohort 3, participants will return after >=28 days for Fed dosing during which subjects will all receive a dose of STG-001 within 30 minutes after completing a high-fat meal (- 2 normal fried eggs, 2 slices white toast, 250 mL whole milk, 2 full rashes middle bacon, 2 serves butter for cooking, 2 serves butter for toast, 2 hash browns)
The cohorts will run sequentially such that the study periods for Cohort 2 occur after Cohort 1. MAD cohort will commence after completion and safety review of SAD cohort 4.

Participants in SAD and MAD cohorts will not be the same.

At the discretion of Sponsor, and with approval of the Review Committee, Sponsor may enroll an additional cohort in the SAD portion of study (Cohort 9) and an additional cohort in the MAD portion of study (Cohort 10). The dose of the MAD cohort will be determined by the Review committee.

Intervention code [1] 314326 0
Treatment: Drugs
Comparator / control treatment
Matching Placebo comprising of di-calcium phosphate anhydrous (fine granular) (A Comprez),Sodium starch glycolate (Explotab), Silicon dioxide (Aerosil 200) and Magnesium stearate (Ligamed MF-2-V)
Control group
Placebo

Outcomes
Primary outcome [1] 319976 0
Part 1: The primary endpoint of the study is safety assessed by incidence and/or clinically significant changes of a combination of ocular and non-ocular adverse events of single ascending PO doses of STG-001.
Systemic adverse reactions will be assessed by physical exam, vital signs, EKG and blood testing (CBC, chemistry, and urinalysis). Ocular adverse reactions, including delayed dark adaptation, will be assessed by ocular exam, visual acuity and color vision testing, intraocular pressure testing, retina exam and a night vision questionnaire. Additional diagnostic testing to monitor ocular adverse events will include ocular coherence tomography, fundus autofluorescence, dark adaptometry and electroretinogram.
Timepoint [1] 319976 0
Physical Examination: Screening and Day 3
Vitals: Screening, Day1,2,3,4 and Day 8
ECG: Screening, Day, 2, 3, Day 8
Telemetry: Day 1, 2 and 3
Lab assessments: Screening, Day 2, Day 4 and Day 8
Visual Acuity , color vision and intra ocular pressure: Screening, Day 3 and Day 8
FAF will be performed at Screening, Day 3 and Day 8
DA will be performed at Screening, Day -1, Day 3 and Day 8
ERG will be performed at Screening, Day 3 and Day 8
OCT will be performed at Screening, Day 3 and Day 8
AE: Screening, Day 1, 2, 3, 4 and Day 8
Night Vision Questionnaire: Screening, Day 2, Day 3 and Day 8
Primary outcome [2] 319977 0
Part 1: – To characterize the safety and tolerability of single PO doses of STG-001 in healthy subjects in a food effect study.
Timepoint [2] 319977 0
Physical Examination: Screening and Day 3
Vitals: Screening, Day1,2,3,4 and Day 8
ECG: Screening, Day, 2, 3, Day 8
Telemetry: Day 1, 2 and 3
Lab assessments: Screening, Day 2, Day 4 and Day 8
Visual Acuity , color vision and intra ocular pressure: Screening, Day 3 and Day 8
FAF will be performed at Screening, Day 3 and Day 8
DA will be performed at Screening, Day -1, Day 3 and Day 8
ERG will be performed at Screening, Day 3 and Day 8
OCT will be performed at Screening, Day 3 and Day 8
AE: Screening, Day 1, 2, 3, 4 and Day 8
Night Vision Questionnaire: Screening, Day 2, Day 3 and Day 8

Primary outcome [3] 319978 0
Part 2: The primary endpoint of the study is safety assessed by incidence and/or clinically significant changes of a combination of ocular and non-ocular adverse events of multiple ascending PO doses of STG-001.
Systemic adverse reactions will be assessed by physical exam, vital signs, EKG and blood testing (CBC, chemistry, and urinalysis). Ocular adverse reactions, including delayed dark adaptation, will be assessed by ocular exam, visual acuity and color vision testing, intraocular pressure testing, retina exam and a night vision questionnaire. Additional diagnostic testing to monitor ocular adverse events will include ocular coherence tomography, fundus autofluorescence, dark adaptometry and electroretinogram.
Timepoint [3] 319978 0
Physical Examination: Screening and Day 8
Vitals: Screening, Day1,2,3,4,5,6,7,8,9 and Day 15
ECG: Screening, Day1, 2, 7,8 and Day 15
Telemetry: Day 1 to Day 9 daily
Lab assessments: Screening, Day 2, Day 4 , Day 6, Day 9 and Day 15
Visual Acuity , color vision and intra ocular pressure: Screening, Day 3, Day 9 and Day 15
FAF will be performed at Screening, Day 9 and Day 15
DA will be performed at Screening, Day 3, Day 9 and Day 15
ERG will be performed at Screening, Day 9 and Day 15
OCT will be performed at Screening, Day 9 and Day 15
AE: Screening, Day 1 to Day 10 all days and Day 15
Night Vision Questionnaire: Screening, Day 2, Day 9 and Day 15

Secondary outcome [1] 370087 0
Parts 1 and 2:
-Percentage of subjects who experience at least 1 TEAE (Treatment emergent adverse events).
Systemic adverse reactions will be assessed by physical exam, vital signs, EKG and blood testing (CBC, chemistry, and urinalysis). Ocular adverse reactions, including delayed dark adaptation, will be assessed by ocular exam, visual acuity and color vision testing, intraocular pressure testing, retina exam and a night vision questionnaire. Additional diagnostic testing to monitor ocular adverse events will include ocular coherence tomography, fundus autofluorescence, dark adaptometry and electroretinogram
Timepoint [1] 370087 0
Treatment-emergent adverse events will be summarized by placebo, each STG-001 dose level, cohort and STG-001 overall for each part of the study.
Part 1
Physical Examination: Screening and Day 3
Vitals: Screening, Day1,2,3,4 and Day 8
ECG: Screening, Day, 2, 3, Day 8
Telemetry: Day 1, 2 and 3
Lab assessments: Screening, Day 2, Day 4 and Day 8
Visual Acuity , color vision and intra ocular pressure: Screening, Day 3 and Day 8
FAF will be performed at Screening, Day 3 and Day 8
DA will be performed at Screening, Day -1, Day 3 and Day 8
ERG will be performed at Screening, Day 3 and Day 8
OCT will be performed at Screening, Day 3 and Day 8
AE: Screening, Day 1, 2, 3, 4 and Day 8
Night Vision Questionnaire: Screening, Day 2, Day 3 and Day 8


Part 2
Physical Examination: Screening and Day 8
Vitals: Screening, Day1,2,3,4,5,6,7,8,9 and Day 15
ECG: Screening, Day1, 2, 7,8 and Day 15
Telemetry: Day 1 to Day 9 daily
Lab assessments: Screening, Day 2, Day 4 , Day 6, Day 9 and Day 15
Visual Acuity , color vision and intra ocular pressure: Screening, Day 3, Day 9 and Day 15
FAF will be performed at Screening, Day 9 and Day 15
DA will be performed at Screening, Day 3, Day 9 and Day 15
ERG will be performed at Screening, Day 9 and Day 15
OCT will be performed at Screening, Day 9 and Day 15
AE: Screening, Day 1 to Day 10 all days and Day 15
Night Vision Questionnaire: Screening, Day 2, Day 9 and Day 15

Secondary outcome [2] 370088 0
Parts 1 and 2
– Assessment of diagnostic imaging changes by FAF (Fundus Autoflourescence).
Timepoint [2] 370088 0
Part 1
-FAF will be performed on Day -1, Day 3 and Day 8
Part 2
FAF - will be performed on Day -1, Day 9 and Day 15
Secondary outcome [3] 370089 0
Parts 1 and 2
– Additional PK parameters will be calculated if useful in the interpretation of the data
This is an exploratory outcome.
Timepoint [3] 370089 0
Part 1
PK sample collection timepoints: Pre-dose and 1, 2, 4, 8, 12, 24, 36, 48 and 72 hours post-dose and Day 8

Part 2
PK sample collection timepoints: Day 1(Pre-dose and 1, 2, 4, 8, 12 and 24 hours post-dose), Day 7 (Pre-dose and 1, 2, 4, 8, 12, 24, 36, 48 and 72 hours post-dose) and Day 15
Secondary outcome [4] 370518 0
Parts 1 and 2
– Additional PD parameters will be calculated if useful in the interpretation of the data.
This is an exploratory outcome.
Timepoint [4] 370518 0
Part 1
PD sample collection timepoints: Pre-dose, Day 5 and Day 8

Part 2
PD sample collection timepoints: Pre-dose, Day 2, Day 7 and Day 15

Secondary outcome [5] 370519 0
Parts 1 and 2
– Assessment of diagnostic imaging changes by DA (Dark Adaptometry)
Timepoint [5] 370519 0
Part 1
-DA will be performed at Screening, Day -1, Day 3 and Day 8
Part 2
DA - will be performed at Screening, Day -1, Day 3, Day 9 and Day 15
Secondary outcome [6] 370520 0
Parts 1 and 2
– Assessment of diagnostic imaging changes by ERG (Electroretinogram)
Timepoint [6] 370520 0
Part 1
-ERG will be performed on Day -1, Day 3 and Day 8
Part 2
ERG - will be performed on Day -1, Day 9 and Day 15
Secondary outcome [7] 370521 0
Parts 1 and 2
– Assessment of diagnostic imaging changes through OCT (Optical Coherence Tomography).
Timepoint [7] 370521 0
Part 1
-OCT will be performed on Day -1, Day 3 and Day 8
Part 2
OCT- will be performed on Day -1, Day 9 and Day 15
Secondary outcome [8] 370522 0
Parts 1 and 2:
Percentage of subjects who discontinue due to an AE.
Timepoint [8] 370522 0
AE will be monitored on an ongoing basis and at every visit and post dose on Day 1 in SAD cohorts and Days 1-7 in MAD cohorts
Secondary outcome [9] 370523 0
Parts 1 and 2:
Percentage of subjects who meet the markedly abnormal criteria for safety laboratory tests at least once post-dose. This is assessed based on clinical observation and Investigator's assessment.
Timepoint [9] 370523 0
Part 1
Lab assessments: Screening, Day 2, Day 4 and Day 8

Part 2
Lab assessments: Screening, Day 2, Day 4 , Day 6, Day 9 and Day 15
Secondary outcome [10] 370524 0
Part 1 and 2
Percentage of subjects who meet the markedly abnormal criteria for vital sign measurements at least once post-dose.
This is assessed based on clinical observation and Investigator's assessment.
Timepoint [10] 370524 0
Part 1
Vitals: Screening, Day1,2,3,4 and Day 8

Part 2
Vitals: Screening, Day1,2,3,4,5,6,7,8,9 and Day 15

Secondary outcome [11] 370525 0
Part 1 and 2
Percentage of subjects who meet the markedly abnormal criteria (clinically significant as by the clinical investigator) for safety 12-lead ECG parameters at least once post-dose.
Timepoint [11] 370525 0
Part 1
ECG: Screening, Day, 2, 3, Day 8

Part 2
ECG: Screening, Day1, 2, 7,8 and Day 15

Secondary outcome [12] 370526 0
Part 1 and 2
-Maximum observed plasma concentration (Cmax).
Timepoint [12] 370526 0
Part 1
PK sample collection timepoints: Pre-dose and 1, 2, 4, 8, 12, 24, 36, 48 and 72 hours post-dose and Day 8

Part 2
PK sample collection timepoints: Day 1(Pre-dose and 1, 2, 4, 8, 12 and 24 hours post-dose), Day 7 (Pre-dose and 1, 2, 4, 8, 12, 24, 36, 48 and 72 hours post-dose) and Day 15
Secondary outcome [13] 370657 0
Part 1 and 2

-Time to reach Cmax (tmax).

Timepoint [13] 370657 0
Part 1
PK sample collection timepoints: Pre-dose and 1, 2, 4, 8, 12, 24, 36, 48 and 72 hours post-dose and Day 8

Part 2
PK sample collection timepoints: Day 1(Pre-dose and 1, 2, 4, 8, 12 and 24 hours post-dose), Day 7 (Pre-dose and 1, 2, 4, 8, 12, 24, 36, 48 and 72 hours post-dose) and Day 15
Secondary outcome [14] 370658 0
Part 1 and 2

-Area under the plasma concentration-time curve from time 0 to infinity (AUC infinity).
Timepoint [14] 370658 0
Part 1
PK sample collection timepoints: Pre-dose and 1, 2, 4, 8, 12, 24, 36, 48 and 72 hours post-dose and Day 8

Part 2
PK sample collection timepoints: Day 1(Pre-dose and 1, 2, 4, 8, 12 and 24 hours post-dose), Day 7 (Pre-dose and 1, 2, 4, 8, 12, 24, 36, 48 and 72 hours post-dose) and Day 15
Secondary outcome [15] 370659 0
Part 1 and 2

-Terminal elimination half-life (t1/2).
Timepoint [15] 370659 0
Part 1
PK sample collection timepoints: Pre-dose and 1, 2, 4, 8, 12, 24, 36, 48 and 72 hours post-dose and Day 8

Part 2
PK sample collection timepoints: Day 1(Pre-dose and 1, 2, 4, 8, 12 and 24 hours post-dose), Day 7 (Pre-dose and 1, 2, 4, 8, 12, 24, 36, 48 and 72 hours post-dose) and Day 15
Secondary outcome [16] 370660 0
Part 1 and 2

PD of STG-001 (plasma RBP4 levels) parameters: % reduction from baseline, % with >60% reduction from baseline and % absolute reduction to <2 mg/dL.
Timepoint [16] 370660 0
Part 1
PD samples will be collected pre dose and on Days 2 and 8.

Part 2
PD samples will be collected pre-dose and on days 2, 7 and 15

Eligibility
Key inclusion criteria
The subject must understand the study procedures and agree to participate by providing written informed consent. The subject must be willing and able to comply with all study procedures and restrictions.
To be eligible for participation in this study, the subject must:
1. Understand the study procedures and agree to participate by providing written informed consent.
2. Healthy male and female subjects.
3. Subjects aged 18 to 55 years, inclusive, with BMI of 18 to 32 kg/m2, inclusive, and body weight >=50 kg.
4. Male subjects must abstain from heterosexual activities or agree to use a double barrier method of contraception from admission to the clinical unit through 90 days after the last dose of study drug and will not donate sperm during this period. Heterosexual WOCBP who are sexually active must not be pregnant upon entering the study that is confirmed by testing (i.e., serum pregnancy test with sensitivity of >=25 mIU/mL at screening, and urine pregnancy test with sensitivity >=50 mIU/mL on Day 1 prior to dosing), be willing to use double-barrier contraception from screening through 60 days after the last dose of study drug, and will not donate eggs during this period. Highly effective double barrier contraception is defined as a condom or diaphragm AND one of the following;
o Birth control pills (The Pill)
o Birth Control Patch (e.g. Ortho Evra)
o NuvaRing®
o Depot or injectable birth control
o IUD
o Documented evidence of surgical sterilization at least 6 months prior to screening visit, i.e., tubal ligation or hysterectomy for women or vasectomy for men.
5. Sign an approved informed consent form for the study.
6. Pre-study ocular exam with no clinically significant abnormalities, including no significant macular abnormalities, DA testing within normal limits and BCVA >= 20/50 visual acuity (or equivalent)
7. Willing and able to comply with the protocol, including attending assessment visits.
8. Be judged to be in good health by the Investigator, based on clinical evaluations including laboratory safety tests, medical history, physical examination, ECG, and vital sign measurements performed at the screening visit and before administration of the initial dose of study drug.
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. The subject is an employee of the sponsor or study site or immediate family member (e.g., spouse, parent, child, sibling) of the sponsor or study site.
2. The subject is a citizen or resident of an EU member State.
3. The subject has a known hypersensitivity or contraindication to any component of STG 001.
4. The subjects has any history of an anaphylaxis event.
5. Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to Check-in (Day -1). Herbal supplements and HRT must be discontinued 28 days prior to Check-in (Day -1). As an exception, paracetamol may be used at doses of less than or equal to 1 g/day. Limited use of nonprescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the Sponsor.
6. The subject has vitamin A deficiency as defined based upon serum values less than 20 mcg/dl (0.7 µmol/L) or clinical signs during slit lamp examination (conjunctival or corneal xerosis; Bitot’s spots; corneal ulcers of scarring not due to trauma or other secondary causes).
7. Has taken non-approved items (supplement containing vitamin A or beta-carotene, liver-based products, or prescription oral retinoid medications) within 30 days prior to admission at the clinical site.
8. Use of medications that may interact with Vitamin A metabolism within 60 days of screening (e.g. Accutane [isotretinoin], doxycycline).
9. Participation in an interventional study of a Vitamin A derivative less than or equal to months prior to screening
10. Presence of significant cardiovascular or cerebrovascular disease, including stroke.
11. Has a clinically significant abnormal electrocardiogram (ECG), or has a corrected QT interval (QTc) that is 450 ms or greater
12. Resting heart rate outside specified limits (less than 40/minute, greater than 100/min upon repeated measurement).
13. History of diabetes, hepatitis, pancreatitis, cirrhosis, liver failure, uncontrolled thyroid disease or hypervitaminosis A.
14. Any surgical procedure within three month of trial entry or anticipated during the trial. If such surgical procedure was within 3 months of trial entry and there was a full recovery with no expected impact on study procedures, data or safety, such a subject would be eligible at the discretion of the PI.
15. Women who are pregnant or nursing.
16. Abnormal blood pressure outside specified limits (90 mm Hg > Systolic > 140 mm Hg and/or 40 mm Hg > Diastolic > 90 mm Hg) upon repeated measurement.
17. Clinically significant abnormal lab results at screening, including liver function test (aspartate transaminase, alanine transaminase, bilirubin and alkaline phosphatase) greater than 1.5 x the ULN
18. Actively participating in an experimental therapy study or have received experimental therapy within 60 days of screening or 5 half-lives, whichever is longer.
19. Any history of significant eye disorders (including retinal disorders) or visual disturbances.
20. In the PI’s opinion, any acute or chronic medical condition, psychiatric condition, physical examination finding or laboratory abnormality that may increase the risk associated with study participation or administration of study treatment or interfere with the interpretation of study results. Minor medical conditions that are not currently being treated with medication and that are not expected to interfere with study procedures, data or participant safety may be considered for inclusion at the discretion of the PI.
21. Participants could be at increased risk of harm or put other people at increased risk of harm (e.g. if they are taxi or Uber drivers), if they were to experience visual impairment like impaired night time vision. Participants must agree to comply with advice of study investigators or study ophthalmologist around modifying activity and taking precautions if visual impairment occurs until such time as the visual impairment resolves, or the participant will be excluded from the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A randomisation list will be generated by the unmasked statistician and be transferred electronically to the pharmacist on site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation generated by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13691 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 26382 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 302628 0
Commercial sector/Industry
Name [1] 302628 0
Stargazer Pharmaceuticals
Address [1] 302628 0
200 Clarendon Street, 45 floor, Mailbox 30
Boston, MA 02116
Country [1] 302628 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Stargazer Pharmaceuticals
Address
200 Clarendon Street, 45 floor, Mailbox 30
Boston, MA 02116
Country
United States of America
Secondary sponsor category [1] 302539 0
None
Name [1] 302539 0
Address [1] 302539 0
Country [1] 302539 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303256 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 303256 0
55 Commercial Rd, Melbourne, VIC 3004
Ethics committee country [1] 303256 0
Australia
Date submitted for ethics approval [1] 303256 0
03/04/2019
Approval date [1] 303256 0
13/05/2019
Ethics approval number [1] 303256 0

Summary
Brief summary
Stargazer Pharmaceuticals. is developing STG-001 a potential oral therapy for patients with
Stargardt's disease.
This study will be conducted in up to 84 healthy volunteers who meet all of the inclusion
criteria and none of the exclusion criteria. The study is to assess the safety and tolerability of STG-001 in normal healthy volunteers.
This includes vital signs, safety labs, ECGs, and ocular and non-ocular examinations.
The drug will be given in single ascending then multiple ascending doses.
The study will also evaluate the PK and PD of the drug after dose administration.
Participants will be entered into standard study cohorts
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93034 0
Dr Ben Snyder
Address 93034 0
Nucleus Network Pty Ltd
5th Floor, Burnet Tower, AMREP Precinct
Commercial Road, Melbourne
VIC, 3004
Country 93034 0
Australia
Phone 93034 0
+61 390768960
Fax 93034 0
Email 93034 0
b.snyder@nucleusnetwork.comau
Contact person for public queries
Name 93035 0
Ms Jasmine Panthaki
Address 93035 0
Nucleus Network Pty Ltd
5th Floor, Burnet Tower, AMREP Precinct
Commercial Road, Melbourne
VIC, 3004
Country 93035 0
Australia
Phone 93035 0
+61 3 9089 8247
Fax 93035 0
Email 93035 0
J.Panthaki@nucleusnetwork.com.au
Contact person for scientific queries
Name 93036 0
Dr Gary Sternberg
Address 93036 0
Stargazer Pharmaceuticals Inc
200 Clarendon Street, 45 floor, Mailbox 30
Boston, MA 02116
Country 93036 0
United States of America
Phone 93036 0
+1-510-913-8357
Fax 93036 0
Email 93036 0
sternberg@stargazerpharma.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a healthy volunteer study and the individual participant results are not useful to the participants or to others outside of the sponsor.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary