Austin, Texas
Austin, Texas, 78744, United States
NCT Number: NCT06301971
The primary purpose of this study is to determine the mass balance, routes, and rates of elimination of total radioactivity and characterize the pharmacokinetics (PK) of emraclidine, metabolite CV-0000364, and total radioactivity in plasma and whole blood following a single oral dose of [14C]-emraclidine in healthy adult male participants.
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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
"Yes" responses for any of the following items on the C-SSRS (within past 12 months):
NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Oral solution/suspension
Other names: CVL-231
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
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
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
Time frame: Up to Day 15
The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe). Greater lethality or potential lethality of suicidal behaviors (endorsed on the behavior subscale) indicates increased risk.
Cerevel Therapeutics, LLC
Industry
A Phase 1, Open-Label Trial to Assess the Mass Balance, Pharmacokinetics, Metabolism, and Excretion of Emraclidine 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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