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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: [14C]-CRN00808; Drug: CRN00808

• Registration Number: NCT04246749
• Lead Sponsor: Crinetics Pharmaceuticals Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-17
• Primary Completion: 2019-10-25
• Study Completion: 2019-10-25
• Status Verified: 2020-01
• Study First Submitted: 2020-01-14
• Study First Submitted QC: 2020-01-27
• Last Update Submitted: 2020-01-27
• Study First Posted: 2020-01-29
• Last Update Posted: 2020-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 11

Inclusion Criteria

1. Male subjects 19 to 55 years of age
2. BMI 18 to 30 kg/m2

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Part A: [14C]-CRN00808 Oral Solution	[14C]-CRN00808	Single oral dose of CRN00808 containing \[14C\]-CRN00808
Part B: CRN00808 Oral Capsule w/ [14C]-CRN00808 IV microtracer	[14C]-CRN00808	Single oral dose of CRN00808 followed by \[14C\]-CRN00808 IV microtracer injection
Part B: CRN00808 Oral Capsule w/ [14C]-CRN00808 IV microtracer	CRN00808	Single oral dose of CRN00808 followed by \[14C\]-CRN00808 IV microtracer injection

Primary Outcome Measures

Name	Time	Method
Mass balance of CRN00808	Up to 21 days (until >90% of dose is recovered)	Total radioactivity in urine and feces following a single oral dose \[14C\]-CRN00808 (expressed as a percentage of the total radioactive dose administered)
Absolute bioavailability of CRN00808	5 days	Absolute bioavailability is calculated from the areas under the curve of intravenous and oral administration

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (t1/2)	Part A: Day 1 to day 21 (depending on recovery of dose). Part B: Day 1 through to Day 7	Assessment of the total elimination half-life of CRN00808 and \[14C\]-CRN00808
Pharmacokinetics (Tmax)	Part A: Day 1 to day 21 (depending on recovery of dose). Part B: Day 1 through to Day 7	Assessment of Time to attain maximum observed plasma concentration of CRN00808 and \[14C\]-CRN00808
Pharmacokinetics (AUC)	Part A: Day 1 to day 21 (depending on recovery of dose). Part B: Day 1 through to Day 7	Assessment of the plasma area under the curve of CRN00808 and \[14C\]-CRN00808
Pharmacokinetics (Vz)	Day 1 through to Day 7	Assessment of Volume of distribution at terminal phase (Part B only)
Pharmacokinetics (CL)	Day 1 through to Day 7	Assessment of the clearance of CRN00808 (Part B only)
Pharmacokinetics (Vz/F)	Part A: Day 1 to day 21 (depending on recovery of dose). Part B: Day 1 through to Day 7	Assessment of Apparent volume of distribution at terminal phase
Pharmacokinetics (CL/F)	Part A: Day 1 to day 21 (depending on recovery of dose). Part B: Day 1 through to Day 7	Assessment of Apparent oral clearance of CRN00808

Trial Locations

Locations (1)

PRA Health Sciences; 🇳🇱 Groningen, Netherlands