A Phase 1, Open Label, Randomized, Two-Period, Crossover Study to Evaluate the Relative Bioavailability of Two Paltusotine Tablet Strengths in Healthy Volunteers
Crinetics Australia Pty Ltd
12 participants
Apr 26, 2022
Interventional
Conditions
Summary
Paltusotine is an oral somatostain receptor 2 (sst2) agonist being developed for the treatment of acromegaly. This single cohort, 2 period study will evaluate the relative bioavailability of two paltusotine tablet strengths in healthy volunteers. Participants will receive 1 dose of 2 x 30mg and 1 dose of 3 x 20mg of paltusotine, across 2 periods in a randomised format as follows: Period 1: 6 Participants to receive 1 dose of 2 x 30mg, 6 Participants to receive 1 dose of 3 x 20mg. 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.
Eligibility
Inclusion Criteria6
- 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
Exclusion Criteria14
- 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
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Interventions
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.
Locations(1)
View Full Details on ANZCTR
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ACTRN12622000491763