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Completed

NCT Number: NCT04246749

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

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.

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Key information

Conditions

Age range

19 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

PRA Health Sciences

Groningen, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

[14C]-CRN00808

Drug

Investigational drug

CRN00808

Drug

Investigational drug

Primary outcomes

  1. Mass balance of CRN00808

    Time frame: 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)

  2. Absolute bioavailability of CRN00808

    Time frame: 5 days

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

Secondary outcomes

  1. Pharmacokinetics (AUC)

    Time frame: 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

  2. Pharmacokinetics (t1/2)

    Time frame: 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

  3. Pharmacokinetics (Tmax)

    Time frame: 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

  4. Pharmacokinetics (CL)

    Time frame: Day 1 through to Day 7

    Assessment of the clearance of CRN00808 (Part B only)

  5. Pharmacokinetics (CL/F)

    Time frame: 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

  6. Pharmacokinetics (Vz)

    Time frame: Day 1 through to Day 7

    Assessment of Volume of distribution at terminal phase (Part B only)

  7. Pharmacokinetics (Vz/F)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Crinetics Pharmaceuticals Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 29, 2020
Registry last updated
Jan 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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