Clinical trial NCT04246749: Mass Balance and Pharmacokinetics of [14C]-CRN00808 in Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Crinetics Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2020-01-29
Enrollment: 11
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Mass balance of CRN00808
timeFrame: Up to 21 days (until >90% of dose is recovered)
measure: Absolute bioavailability of CRN00808
timeFrame: 5 days
Secondary outcomes:
measure: Pharmacokinetics (AUC)
timeFrame: Part A: Day 1 to day 21 (depending on recovery of dose). Part B: Day 1 through to Day 7
measure: Pharmacokinetics (t1/2)
timeFrame: Part A: Day 1 to day 21 (depending on recovery of dose). Part B: Day 1 through to Day 7
measure: Pharmacokinetics (Tmax)
timeFrame: Part A: Day 1 to day 21 (depending on recovery of dose). Part B: Day 1 through to Day 7
measure: Pharmacokinetics (CL)
timeFrame: Day 1 through to Day 7
measure: Pharmacokinetics (CL/F)
timeFrame: Part A: Day 1 to day 21 (depending on recovery of dose). Part B: Day 1 through to Day 7
measure: Pharmacokinetics (Vz)
timeFrame: Day 1 through to Day 7
measure: Pharmacokinetics (Vz/F)
timeFrame: Part A: Day 1 to day 21 (depending on recovery of dose). Part B: Day 1 through to Day 7
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: PRA Health Sciences
Study officials:
References: