Emraclidine
DrugOral tablets
Other names: CVL-231
NCT Number: NCT05940402
The primary purpose of this study is to assess the effect of renal impairment on the pharmacokinetics (PK) of emraclidine following administration of a single oral dose in participants with mild, moderate, and severe renal impairment relative to matched participants with normal renal function.
Looking for future studies?
Notify Me18 year–75 year
All sexes
Interventional
Phase 1
Tustin, California, Tustin, California, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
In addition, participants who plan to receive SARS-CoV-2 vaccination or booster while participating in the trial or for a minimum of 7 days (to cover at least 5 half-lives of IMP) after the last dose of investigational medicinal product (IMP) will be excluded.
NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Oral tablets
Other names: CVL-231
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 5
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 5
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 5
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 5
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 5
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 5
Time frame: Up to Day 15
Time frame: Up to Day 5
Time frame: Up to Day 5
Time frame: Up to Day 5
Time frame: Up to Day 5
Time frame: Up to Day 5
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 Renal Impairment Compared With Adult Participants With Normal Renal 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.
Published trials that share one or more normalized conditions with this study.
NCT03896750
Actinomycetales Infections, Bacterial Infections
Miami, Florida, United States
View Trial DetailsNCT03289208
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Tokyo, Japan
View Trial DetailsNCT07217886
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Orlando, Florida, United States
View Trial DetailsNCT06671444
Dyssomnias, Female Urogenital Diseases
Nanjing, Jiangsu, China
View Trial Details