Status:
COMPLETED
A Study in Healthy Male Subjects to Investigate the Effect of Famotidine and Efavirenz on the Way the Body Takes up, Distributes, and Gets Rid of Daridorexant.
Lead Sponsor:
Idorsia Pharmaceuticals Ltd.
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
A study in healthy male subjects to investigate the effect of famotidine and efavirenz on the way the body takes up, distributes, and gets rid of daridorexant.
Eligibility Criteria
Inclusion
- Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
- Healthy male subjects aged between 18 and 45 years (inclusive) at Screening.
Exclusion
- Clinically relevant findings on the physical examination at Screening.
- Clinically relevant abnormalities on 12-lead ECG, measured after at least 5 min in a supine position at Screening.
- Clinically relevant findings in clinical laboratory tests (hematology, clinical chemistry) at Screening and on Day -1.
- History of major medical or surgical disorders which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatment(s) (appendectomy and herniotomy allowed, cholecystectomy not allowed).
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
- Moderate or severe renal insufficiency (creatinine clearance \< 60 mL/min calculated with the Cockcroft Gault formula) at Screening.
- Total bilirubin \> 1.5 x Upper Limit of Normal at Screening.
Key Trial Info
Start Date :
May 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 26 2020
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04390334
Start Date
May 13 2020
End Date
June 26 2020
Last Update
September 16 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
CRS Clinical Research Services Mannheim GmbH
Mannheim, Germany, 68167