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Trial registered on ANZCTR


Registration number
ACTRN12622000491763
Ethics application status
Approved
Date submitted
25/02/2022
Date registered
28/03/2022
Date last updated
14/06/2023
Date data sharing statement initially provided
28/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 1, Open Label, Randomized, Two-Period, Crossover Study to Evaluate the Relative Bioavailability of Two Paltusotine Tablet Strengths in Healthy Volunteers
Scientific title
A Phase 1, Open Label, Randomized, Two-Period, Crossover Study to Evaluate the Relative Bioavailability of Two Paltusotine Tablet Strengths in Healthy Volunteers
Secondary ID [1] 306458 0
CRN00808-13
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acromegaly 325303 0
Condition category
Condition code
Metabolic and Endocrine 322701 322701 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention for this study, paltusotine, is an orally bioavailable small molecule somatostatin receptor agonist that lowers growth hormone levels in acromegaly patients. Paltusotine will be supplied as 20 mg and 30 mg tablets.
The study will consist of 1 cohort in which participants will receive 1 dose of 2 x 30mg and 1 dose of 3 x 20mg of paltusotine (60mg total), across 2 periods in a randomised format as follows:
Period 1: 6 Participants to receive 1 dose of 2 x 30mg tablets, 6 Participants to receive 1 dose of 3 x 20mg tablets.
Period 2: Participants to receive the other dose to what was received in Period 1.
Participants will receive each dose with approximately 240ml of water, after a 10 hour overnight fast. Participants will then fast for further 4 hours after dosing. There will be 10 to 14 days between doses.
There will be up to 12 subjects enrolled in this study, with at least 4 male and 4 females.
Intervention code [1] 322889 0
Treatment: Drugs
Comparator / control treatment
This is a two-period crossover study in which all participants receive both treatment formats. Active control for the study is the paltusotine 20 mg tablet (reference tablet).
Control group
Active

Outcomes
Primary outcome [1] 330501 0
Relative bioavailability of paltusotine tablets at the same dose (60 mg) using tablets of two different strengths; three 20 mg tablets and two 30 mg tablets, as assessed by Pharmacokinetic blood plasma concentration.
Timepoint [1] 330501 0
Pharmacokinetic blood plasma sampling is to occur at the following timepoints:
Periods 1 and 2: within 30 min pre dose, 15 min, 30 min, 45 min, 1 hr, 1.25 hrs, 1.5 hrs, 2.0 hrs, 3.0 hrs, 4.0 hrs, 6.0 hrs, 8.0 hrs, 10 hrs, 12 hrs, 24 hrs, 48 hrs, 72 hrs, 96 hrs and 144hrs post dose.
Secondary outcome [1] 406457 0
Safety and tolerability of paltusotine as assessed by Physical Examinations, 12 Lead ECG, Vital Sign measurements, Safety Laboratory tests, and adverse event assessments.
Timepoint [1] 406457 0
Physical Examinations will be performed at the following timepoints:
Screening, Day -1 (period 1 and 2), and Day 7 (period 2 only)
12 Lead ECG will be performed in triplicate at the following timepoints:
Screening, Period 1 and 2 at Day -1, Day 1 1 hr and 3 hrs post dose, Day 2 24hrs post dose, and Day 7 (period 2 only)
Vital signs, including Blood Pressure (via digital blood pressure monitor), Temperature (via digital tympanic thermometer) and Respiratory rate (manual count), at the following timepoints: Screening, Period 1 and 2 at Day -1, Day 1 1 hr and 3 hrs post dose, Day 2 24hrs post dose, and Day 7 (period 2 only)
Safety Laboratory tests, including Serum Chemistry, Haematology and urinalysis, will be performed as the following timepoints:
Screening, Period 1 and 2 at Day -1, prior to breakfast on Day 2, and prior to breakfast on Day 7 (Period 2 only).
Adverse events will be recorded from the time that a subject signs consent until the final follow up visit. Site staff will question subjects on their health when conducting other assessments throughout the trial. Adverse events will be assessed by study investigators. Adverse events known to be associated with somatostatin receptor agonists include abdominal pain, diarrhea, and nausea
Secondary outcome [2] 406458 0
Average bioequivalence (ABE) paltusotine tablets at the same dose (60 mg) using tablets of two different strengths; three 20 mg tablets and two 30 mg tablets, as assessed by Pharmacokinetic blood plasma concentration.
Timepoint [2] 406458 0
Pharmacokinetic blood plasma sampling is to occur at the following timepoints:
Periods 1 and 2: within 30 min pre dose, 15 min, 30 min, 45 min, 1 hr, 1.25 hrs, 1.5 hrs, 2.0 hrs, 3.0 hrs, 4.0 hrs, 6.0 hrs, 8.0 hrs, 10 hrs, 12 hrs, 24 hrs, 48 hrs, 72 hrs, 96 hrs and 144hrs post dose.

Eligibility
Key inclusion criteria
- Male and female subjects 18 to 65 years of age
- BMI 18 to 30 kg/m2
- Females must be non-pregnant and non-lactating, and either surgically sterile, post-
menopausal, or must agree to not donate ova and to use a highly effective or two clinically acceptable methods of contraception
- male subjects must use a condom and his female partner of childbearing potential must use a highly effective or clinically acceptable form of contraception. Male subjects must also agree to not donate sperm for the duration of the study and until at least 3 months after the last dose of study drug.
- Willing to provide signed informed consent
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Prior treatment with paltusotine
- Any uncontrolled or active major systemic disease
- History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years.
- Active acute or chronic infection
- Use of any investigational drug within the past 60 days
- Had an unstable psychological disorder less than or equal to 1 year before screening based on the subject’s medical history.
- Had a medically significant illness within 30 days of admission.
- Use of any investigational drug within the past 60 days or 5 half-lives, whichever is longer prior to the first dosing of study drug.
- Use of any prior medication without approval of the Investigator within 14 days prior to admission.
- History of or current alcohol abuse
- Heavy use of Tobacco and/or nicotine products
- Taking moderate or strong CYP3A4 inhibitors or inducers.
- Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in the study
- Positive COVID-19 rapid Antigen test

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/04/2022
Actual
26/04/2022
Date of last participant enrolment
Anticipated
26/04/2022
Actual
31/05/2022
Date of last data collection
Anticipated
15/06/2022
Actual
27/07/2022
Sample size
Target
12
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 310809 0
Commercial sector/Industry
Name [1] 310809 0
Crinetics Australia Pty Ltd
Country [1] 310809 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Crinetics Australia Pty Ltd
Address
Crinetics Australia Pty Ltd
17 Praeger Street Chapel Hill,
QLD 4069 Australia
Country
Australia
Secondary sponsor category [1] 312054 0
Commercial sector/Industry
Name [1] 312054 0
Avance Clinical Pty Ltd
Address [1] 312054 0
Avance Clinical Pty Ltd
Level 1, 2 Ann Nelson Drive
Thebarton, SA, 5043 Australia
Country [1] 312054 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310377 0
BellBerry Limited, Committee C - EC00430
Ethics committee address [1] 310377 0
Ethics committee country [1] 310377 0
Australia
Date submitted for ethics approval [1] 310377 0
09/02/2022
Approval date [1] 310377 0
22/03/2022
Ethics approval number [1] 310377 0

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

Contacts
Principal investigator
Name 117438 0
Prof Sepehr Shakib
Address 117438 0
CMAX Clinical Research Pty Ltd
Level 5, 21 North Terrace
Adelaide, SA, 5000
AUSTRALIA
Country 117438 0
Australia
Phone 117438 0
+61 411 100 278
Fax 117438 0
Email 117438 0
Sepehr.Shakib@cmax.com.au
Contact person for public queries
Name 117439 0
Sepehr Shakib
Address 117439 0
CMAX Clinical Research Pty Ltd
Level 5, 21 North Terrace
Adelaide, SA, 5000
AUSTRALIA
Country 117439 0
Australia
Phone 117439 0
+61 411 100 278
Fax 117439 0
Email 117439 0
Sepehr.Shakib@cmax.com.au
Contact person for scientific queries
Name 117440 0
Sepehr Shakib
Address 117440 0
CMAX Clinical Research Pty Ltd
Level 5, 21 North Terrace
Adelaide, SA, 5000
AUSTRALIA
Country 117440 0
Australia
Phone 117440 0
+61 411 100 278
Fax 117440 0
Email 117440 0
Sepehr.Shakib@cmax.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.