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Trial registered on ANZCTR


Registration number
ACTRN12615000560594
Ethics application status
Approved
Date submitted
14/05/2015
Date registered
29/05/2015
Date last updated
22/01/2019
Date data sharing statement initially provided
22/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Phase I, Randomised, Open Label Study of the Safety, Tolerability and Pharmacokinetics of Single Sublingual or Oral Dose of GDN-1 in Adult Healthy Volunteers.
Scientific title
A Phase I, Randomised, Open Label Study of the Safety, Tolerability and Pharmacokinetics of Single Sublingual or Oral Dose of GDN-1 in Adult Healthy Volunteers.
Secondary ID [1] 286700 0
GOR-T3-1001
Universal Trial Number (UTN)
U1111-1170-1911
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
This trial is to assess the tolerability and pharmacokinetics in healthy adult volunteers and does not focus on any particular health condition or problem.
Subsequent studies are planned to evaluate efficacy in promoting improved exercise endurance and recovery, reduced muscle damage and soreness post exercise and for its lipid lowering effects in appropriate populations. 295056 0
Condition category
Condition code
Other 295307 295307 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single dose of GDN-1 will be administered on Day 0 either sublingually or orally in either a fed or fasted state according to the randomisation schedule. Patients will be randomised into one of six treatment groups:
Group 1, 10mg of sublingual GDN-1 in a fasted state,
Group 2, 20mg of sublingual GDN-1 in a fasted state,
Group 3, 40mg of sublingual GDN-1 in a fasted state,
Group 4, 40mg of sublingual GDN-1 in a fed state,
Group 5, 40mg of oral GDN-1 in a fasted state,
Group 6, 40mg of oral GDN-1 in a fed state,
Intervention code [1] 291847 0
Treatment: Drugs
Comparator / control treatment
There are 6 treatment arms which include doses at 10mg, 20mg and 40mg.
Control group
Dose comparison

Outcomes
Primary outcome [1] 295043 0
To evaluate:
*The safety and tolerability of GDN-1 in healthy adults following a single dose.
Timepoint [1] 295043 0
Safety and tolerability:
*Adverse events over the course of the study (from the time of drug administration until the end of study - Day 7).
*Changes in vital signs, physical examination, haematology, biochemistry, urinalysis and 12-lead ECG within 24 hours post receiving the single dose
Primary outcome [2] 295108 0
The pharmacokinetic (PK) profile of GDN-1 following administration of a single sublingual or oral dose to healthy adults in the fed and fasted states.
Timepoint [2] 295108 0
Pharmacokinetics:
*Peak plasma concentration (Cmax) obtained directly from the plasma concentration data without interpolation
*Time to peak plasma concentration (tmax) obtained directly from the plasma concentration data without interpolation.
*Elimination half-life (t 1/2)
*Area under the concentration-time curve from time 0 to the last time point evaluated (AUC(0–t))
*Area under the concentration-time curve from time 0 and extrapolated to infinity (AUC(0–inf))

PK sampling will occur pre-dose, 5, 10, 15, 30 and 45 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours.
Secondary outcome [1] 314664 0
EXPLORATORY OBJECTIVE:
To evaluate in subjects randomised to receive the sublingual Investigational Medicinal Product:
*The tolerability of the sublingual GDN-1 formulation in terms of palatability (using a 5 point scale)
Timepoint [1] 314664 0
EXPLORATORY ENDPOINTS:

*Subject’s judgement of the palatability of the sublingual Investigational Product utilising a 5 point scale (within 15 minutes of dosing).
Secondary outcome [2] 314890 0
To evaluate in subjects randomised to receive the sublingual Investigational Medicinal Product:
*The tolerability of the sublingual GDN-1 formulation in terms of disintegration time (observational).
Timepoint [2] 314890 0
Time taken for the sublingual Investigational Product to disintegrate (less than or equal to 10 minutes);

Eligibility
Key inclusion criteria
Subjects who:
1. Are adults aged between 18 and 55 years inclusive at the time of consent.
2. Have a Body Mass Index (BMI) of greater than or equal to 18.5 and less than or equal to 27kg/m2
3. Have voluntarily given written informed consent.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Subjects who:

1. Are female and breastfeeding and/or of reproductive potential with a positive urine beta human chorionic gonadotropin (beta-HCG) pregnancy test at either Screening or the Baseline Visit;
2. Are of child bearing potential and are not able or willing to comply with contraceptive requirements for study participation;
3. Are taking regular prescription or OTC medications, other than contraception medications within 30 days of the Baseline Visit and are unwilling to abstain from taking these for the duration of the study;
4. Received blood or plasma derivatives in the 3 months preceding the first study dosing
5. Donated blood in the three months preceding the first study dosing or intend to make blood donation during the study, or within the three months following the study completion
6. Volunteers that are unable to comply with the study procedures/schedule including but not limited to being able to fast or consume the standard meals that will be provided.
7. Are taking Vitamin E or Vitamin E containing preparations within the last 3 months prior to the Baseline Visit and are unwilling to abstain from taking these for the duration of the study;
8. Have a history of or current clinically significant gastrointestinal, hepatic, renal, cardiovascular, respiratory, endocrine, oncological, immunodeficiency, neurological, metabolic, haematological or autoimmune disorder or other clinically significant medical conditions that in the investigator’s opinion, may increase the risk of participation;
9. Have an existing impairment to their alimentary tract (including oral cavity) which may interfere with investigational product administration and absorption;
10. Have an impaired sense of taste (self reported);
11. Have an active infection;
12. Have a history of chronic alcohol or drug abuse in the three-months period prior to Screening;
13. Are current smokers, or have a history of smoking within the three months prior to Screening;
14. Have a history of adverse reactions to any of the study medications or components;
15. Have taken aspirin or other medication which may increase the risk of bleeding within the 2 weeks prior to Baseline;
16. Are known to be HIV, hepatitis B or C positive (note, these will not be tested for);
17. Have laboratory blood values:
a. Haemoglobin <120 grams/litre (g/L) for men and <11.0 g/L for women
b. Neutrophil count <1 x 109/L
c. Platelet count < 80 x 109/L
d. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 times the upper limit of normal (ULN)
e. Amylase >1.5 times ULN (unless serum lipase is less than or equal to 1.5 times ULN)
f. Subjects with an estimated creatinine clearance of <80 mL/minute (min)
g. INR > ULN
18. Have received any investigational drug within 30 days prior to the Baseline visit

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)
Once eligibility has been confirmed by the investigator, subjects will be assigned a randomisation number. The investigator will use the next available subject randomisation number which will correspond to the treatment allocation. This is an open label study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The independent statistician will generate the randomisation schedule. The randomisation list will be a random permuted block design with a variable block size.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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
28/05/2015
Actual
28/05/2015
Date of last participant enrolment
Anticipated
Actual
30/06/2015
Date of last data collection
Anticipated
Actual
1/12/2015
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 291268 0
Commercial sector/Industry
Name [1] 291268 0
Gordagen Pharmaceuticals Pty Ltd
Country [1] 291268 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Gordagen Pharmaceuticals Pty Ltd
Address
737 Burwood Road
Hawthorn East, Victoria 3123
Country
Australia
Secondary sponsor category [1] 289941 0
None
Name [1] 289941 0
Address [1] 289941 0
Country [1] 289941 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292827 0
Bellberry Limited
Ethics committee address [1] 292827 0
Ethics committee country [1] 292827 0
Australia
Date submitted for ethics approval [1] 292827 0
22/04/2015
Approval date [1] 292827 0
21/05/2015
Ethics approval number [1] 292827 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57234 0
Dr Janakan Krishnarajah
Address 57234 0
Linear Clinical Research Limited
QEII Medical Centre
First Floor, B Block Hospital Avenue
Nedlands WA 6009 Australia
Country 57234 0
Australia
Phone 57234 0
+61 (08) 6382 5100
Fax 57234 0
Email 57234 0
contactus@linear.org.au
Contact person for public queries
Name 57235 0
Ric DeGaris
Address 57235 0
Gordagen Pharmaceuticals Pty Ltd
737 Burwood Road,
Hawthorn East, Victoria, 3123
Country 57235 0
Australia
Phone 57235 0
+61 (0) 3 8862 6471
Fax 57235 0
Email 57235 0
info@gordagen.com
Contact person for scientific queries
Name 57236 0
Ric DeGaris
Address 57236 0
Gordagen Pharmaceuticals Pty Ltd
737 Burwood Road,
Hawthorn East, Victoria, 3123
Country 57236 0
Australia
Phone 57236 0
+61 (0) 3 8862 6471
Fax 57236 0
Email 57236 0
info@gordagen.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Will not be publicly available at this time.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.