Austin, Texas
Austin, Texas, 78744, United States
NCT Number: NCT06435923
The primary purpose of this trial is to determine the mass balance, routes, and rates of elimination of total radioactivity and characterize the pharmacokinetics (PK) of darigabat, and total radioactivity in plasma and whole blood following administration of a single oral dose of [14C]-darigabat in healthy adult male participants.
Looking for future studies?
Notify Me18 year–55 year
Male
Interventional
Phase 1
Austin, Texas, 78744, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Oral capsule
Other names: CVL-865; PF-06372865
Time frame: Pre-dose and at multiple time points post-dose up to Day 15
Time frame: Pre-dose and at multiple time points post-dose up to Day 15
Time frame: Pre-dose and at multiple time points post-dose up to Day 15
Time frame: Pre-dose and at multiple time points post-dose up to Day 15
Time frame: Pre-dose and at multiple time points post-dose up to Day 15
Time frame: Pre-dose and at multiple time points post-dose up to Day 15
Time frame: Pre-dose and at multiple time points post-dose up to Day 15
Time frame: Pre-dose and at multiple time points post-dose up to Day 15
Time frame: Pre-dose and at multiple time points post-dose up to Day 15
Time frame: Pre-dose and at multiple time points post-dose up to Day 15
Time frame: Pre-dose and at multiple time points post-dose up to Day 15
Urine PK parameters will be assessed.
Time frame: Pre-dose and at multiple time points post-dose up to Day 15
Fecal PK parameters will be assessed.
Time frame: Pre-dose and at multiple time points post-dose up to Day 15
Time frame: Pre-dose and at multiple time points post-dose up to Day 15
Time frame: Pre-dose and at multiple time points post-dose up to Day 15
Time frame: Up to Day 16
Time frame: Up to Day 15
Time frame: Up to Day 15
Time frame: Up to Day 15
Time frame: Up to Day 15
Cerevel Therapeutics, LLC
Industry
A Phase 1, Open-Label Trial to Assess the Absorption, Metabolism, Excretion, and Mass Balance of [14C]-Darigabat Following a Single Oral Dose in Healthy Adult Male Participants
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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