PRA Health Sciences
Groningen, Netherlands
NCT Number: NCT04246749
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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Notify Me19 year–55 year
Male
Interventional
Phase 1
Groningen, Netherlands
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Investigational drug
Investigational drug
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)
Time frame: 5 days
Absolute bioavailability is calculated from the areas under the curve of intravenous and oral administration
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
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
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
Time frame: Day 1 through to Day 7
Assessment of the clearance of CRN00808 (Part B only)
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
Time frame: Day 1 through to Day 7
Assessment of Volume of distribution at terminal phase (Part B only)
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
Crinetics Pharmaceuticals Inc.
Industry
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
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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