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

Healthy Volunteers Clinical Trial

Official title:

A Phase 1, Open-label, Two-cohort, Single Dose Study to Assess the Mass Balance, Route of Elimination, and Metabolic Profile of [14C] Labeled CRN00808 and Absolute Bioavailability of CRN00808 in Healthy Male Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04246749
• Other study ID #: CRN00808-06
• Status: Completed
• Phase: Phase 1
• Start date: September 17, 2019
• Est. completion date: October 25, 2019

Study information

• Verified date: January 2020
• Source: Crinetics Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: October 25, 2019
• Est. primary completion date: October 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• [14C]-CRN00808
Investigational drug
• CRN00808
Investigational drug

Locations

Country	Name	City	State
Netherlands	PRA Health Sciences	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Crinetics Pharmaceuticals Inc.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mass balance of CRN00808	Total radioactivity in urine and feces following a single oral dose [14C]-CRN00808 (expressed as a percentage of the total radioactive dose administered)	Up to 21 days (until >90% of dose is recovered)
Primary	Absolute bioavailability of CRN00808	Absolute bioavailability is calculated from the areas under the curve of intravenous and oral administration	5 days
Secondary	Pharmacokinetics (AUC)	Assessment of the plasma area under the curve of CRN00808 and [14C]-CRN00808	Part A: Day 1 to day 21 (depending on recovery of dose). Part B: Day 1 through to Day 7
Secondary	Pharmacokinetics (t1/2)	Assessment of the total elimination half-life of CRN00808 and [14C]-CRN00808	Part A: Day 1 to day 21 (depending on recovery of dose). Part B: Day 1 through to Day 7
Secondary	Pharmacokinetics (Tmax)	Assessment of Time to attain maximum observed plasma concentration of CRN00808 and [14C]-CRN00808	Part A: Day 1 to day 21 (depending on recovery of dose). Part B: Day 1 through to Day 7
Secondary	Pharmacokinetics (CL)	Assessment of the clearance of CRN00808 (Part B only)	Day 1 through to Day 7
Secondary	Pharmacokinetics (CL/F)	Assessment of Apparent oral clearance of CRN00808	Part A: Day 1 to day 21 (depending on recovery of dose). Part B: Day 1 through to Day 7
Secondary	Pharmacokinetics (Vz)	Assessment of Volume of distribution at terminal phase (Part B only)	Day 1 through to Day 7
Secondary	Pharmacokinetics (Vz/F)	Assessment of Apparent volume of distribution at terminal phase	Part A: Day 1 to day 21 (depending on recovery of dose). Part B: Day 1 through to Day 7