A Phase 1, Open-label, Multi-Period, Single Sequence Study to Evaluate the Relative Bioavailability, Performance, and Safety of Two Solid Oral Doses (Paltusotine Tablets) in Healthy Volunteers

Phase 1

Completed

• Conditions: Metabolic and Endocrine - Other endocrine disorders; Acromegaly

• Registration Number: ACTRN12622000704796
• Lead Sponsor: Crinetics Australia Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-16
• Study Completion: 2022-07-30
• Last Update Posted: 27 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 18

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 use a highly effective or two clinically acceptable methods of contraception for the duration of the study and for 30 days after the last study visit.
- Male subjects must use a condom and his female partner of childbearing potential must use a highly effective or clinically acceptable form of contraception for the duration of the study and until at least 3 months after the last dose of study drug. 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 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.
- 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.
- Poor CYP2C19 metabolizers, or ultrarapid metabolizers as determined from blood sample collected during Screening.
- Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified