An open label, single cohort, randomized, 4-period crossover Phase 1 study to determine the effect of meal timing relative to CRN00808 administration on the safety and pharmacokinetics of CRN00808 in healthy volunteers

Phase 1

Completed

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

• Registration Number: ACTRN12618001646235
• Lead Sponsor: Crinetics Australia Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-04
• Study Completion: 2018-12-14
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Male and female subjects 18 to 70 years of age
- 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
- Willing to provide signed informed consent

Exclusion Criteria

- Prior treatment with CRN00808
- Any uncontrolled or active major systemic disease which makes study participation
unsafe or could interfere with evaluation of the endpoints of the study.
- History or presence of malignancy except adequately treated basal cell and squamous
cell carcinomas of the skin within the past 5 years.
- Use of any investigational drug within the past 60 days
- Have a medically significant abnormality observed during screening or the admission physical examination or in any other baseline measurements
- Use of any prior medication without approval of the investigator within 14 days prior to admission
- Tested positive at screening for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab) or has a history of a positive result
- History of alcohol or substance abuse in the past 12 months
- Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this Phase 1 study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics parameters (AUC, Cmax, Tmax, Tlag and T1/2) following single doses of CRN00808 in male and female subjects derived from plasma concentrations of CRN00808. [PK Plasma sampling, collected at the following timepoints; <br>15 mins pre-dose, 15 mins, 30 mins, 45 mins, 1 hr, 1.25 hr, 1.5 hr, 2.0 hr, 3.0 hr, 4.0 hr, 6.0 hr, 8.0 hr, 10 hr, 12 hr, 18 hr, 24 hr, 72 hr, 120 hr post dosing in each period. A final sample will also be collected on Day 33. <br>]