A Phase 1, Multi-Cohort, Single Dose Study to Assess The Relative Bioavailability, Performance, and Safety of Two Novel Formulations of CRN00808

Phase 1

Completed

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

• Registration Number: ACTRN12619001562167
• Lead Sponsor: Crinetics Australia Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-13
• Study Completion: 2021-05-21
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

Male and female subjects 18 to 55 years of age (Cohorts 1, 2 and 4)
- Male and Female subjects 18 to 65 years of age (Cohort 3 and 5)
- BMI 18 to 30 kg/m2
- Females must be non-pregnant and non-lactating, and either surgically sterile, post- menopausal, or using effective method(s) of birth control
- male subjects must use a condom, or his female partner of childbearing potential must use an effective 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 Criteria

- Prior treatment with CRN00808
- 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
- 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified