Mass Balance and Pharmacokinetics of [14C]-CRN00808 in Healthy Volunteers

NCT ID: NCT04246749

Last Updated: 2020-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-17
• Study Completion Date: 2019-10-25

Brief Summary

A phase 1 healthy volunteer study to assess the mass balance, elimination, and metabolic profile of CRN00808. The study will be conducted in 2 parts: Part A, to characterize the absorption, distribution, metabolism, excretion, and mass balance of orally administered radio-labeled CRN00808; Part B, to determine the absolute bioavailability of CRN00808 administered using CRN00808 and radio-labeled CRN00808 as intravenous and oral forms.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part A: [14C]-CRN00808 Oral Solution

Single oral dose of CRN00808 containing \[14C\]-CRN00808

Group Type: EXPERIMENTAL

[14C]-CRN00808

Intervention Type: DRUG

Investigational drug

Part B: CRN00808 Oral Capsule w/ [14C]-CRN00808 IV microtracer

Single oral dose of CRN00808 followed by \[14C\]-CRN00808 IV microtracer injection

Group Type: EXPERIMENTAL

[14C]-CRN00808

Intervention Type: DRUG

Investigational drug

CRN00808

Intervention Type: DRUG

Investigational drug

Interventions

[14C]-CRN00808

Investigational drug

Intervention Type: DRUG

CRN00808

Investigational drug

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male subjects 19 to 55 years of age

2. BMI 18 to 30 kg/m2

Exclusion Criteria

1. Any uncontrolled or active major systemic disease including, but not limited to: acromegaly (with or without pituitary surgery or radiation therapy), cardiac, pulmonary, gastrointestinal, metabolic, urogenital, neurological, immunological, psychiatric, or neoplastic disorder with metastatic potential

2. History or presence of malignancy within the past 5 years. Subjects who have been successfully treated (for 3 months or longer) with no recurrence of basal or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix may be enrolled.

3. Use of any investigational drug within the past 60 days or 5 half-lives, whichever is longer

4. Have a medically significant abnormality observed during screening or the admission physical examination or in any other baseline measurements

5. Use of any prior medication without approval of the investigator within 14 days prior to admission

6. 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

7. History of alcohol or substance abuse in the past 6 months

8. Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this Phase 1 study

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Crinetics Pharmaceuticals Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

PRA Health Sciences

Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

CRN00808-06

Identifier Type: -

Identifier Source: org_study_id