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

NCT04246749 | Completed Phase 1 FDA Drug

• 1 other identifier: CRN00808-06
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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)

• Absolute bioavailability of CRN00808

  Absolute bioavailability is calculated from the areas under the curve of intravenous and oral administration

  5 days

Secondary Outcomes (7)

• Pharmacokinetics (AUC)

  Part A: Day 1 to day 21 (depending on recovery of dose). Part B: Day 1 through to Day 7

• Pharmacokinetics (t1/2)

  Part A: Day 1 to day 21 (depending on recovery of dose). Part B: Day 1 through to Day 7

• Pharmacokinetics (Tmax)

  Part A: Day 1 to day 21 (depending on recovery of dose). Part B: Day 1 through to Day 7

• Pharmacokinetics (CL)

  Day 1 through to Day 7

• Pharmacokinetics (CL/F)

  Part A: Day 1 to day 21 (depending on recovery of dose). Part B: Day 1 through to Day 7

Study Arms (2)

Part A: [14C]-CRN00808 Oral Solution

EXPERIMENTAL

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

Drug: [14C]-CRN00808

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

EXPERIMENTAL

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

Drug: [14C]-CRN00808; Drug: CRN00808

Interventions

[14C]-CRN00808 DRUG

Investigational drug

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

CRN00808 DRUG

Investigational drug

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

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male subjects 19 to 55 years of age
• BMI 18 to 30 kg/m2

You may not qualify if:

• 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
• 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.
• Use of any investigational drug within the past 60 days or 5 half-lives, whichever is longer
• 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 6 months
• Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this Phase 1 study

Sponsors & Collaborators

• Crinetics Pharmaceuticals Inc.: lead

Study Sites (1)

PRA Health Sciences

Groningen, Netherlands

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 29, 2020
• Study Start: September 17, 2019
• Primary Completion: October 25, 2019
• Study Completion: October 25, 2019
• Last Updated: January 29, 2020

Record last verified: 2020-01

Locations

NL (1)