Emraclidine
DrugTablet
Other names: CVL-231
NCT Number: NCT05935033
The primary purpose of this study is to assess the effect of hepatic impairment on the pharmacokinetics (PK) of emraclidine following administration of a single oral dose in participants with mild, moderate, and severe hepatic impairment relative to matched participants with normal hepatic function.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 1
Miami, Florida, Miami, Florida, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Tablet
Other names: CVL-231
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 7
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 7
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 7
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 7
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 7
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 7
Time frame: Day 1 up to Follow-up (Day 15)
Time frame: Days 1 to 7
Time frame: Days 1 to 7
Time frame: Days 1 to 7
Time frame: Days 1 to 7
Time frame: Days 1 to 7
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.
AbbVie
Industry
A Phase 1, Open-label Trial to Evaluate the Pharmacokinetics and Safety Following a Single Dose of Emraclidine in Adult Participants With Mild, Moderate, and Severe Hepatic Impairment Compared With Adult Participants With Normal Hepatic Function
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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