Status:
COMPLETED
Effect of Cimetidine on the Pharmacokinetics of Lucerastat in Healthy Subjects
Lead Sponsor:
Idorsia Pharmaceuticals Ltd.
Conditions:
Healthy Subjects
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
A study in healthy male subjects to investigate whether repeated administrations of cimetidine (a medication which decreases the amount of acid in the stomach) can affect the fate in the body (amount ...
Eligibility Criteria
Inclusion
- Signed informed consent in the local language prior to any study-mandated procedure.
- Body mass index from 18.0 to 30.0 kg/m2 (inclusive) at Screening.
- Normal renal function confirmed by creatinine clearance ≥ 80 mL/min using Cockroft-Gault formula at Screening.
Exclusion
- Known hypersensitivity to cimetidine, lucerastat, or drugs of the same class, or any of their excipients.
- History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might 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.
Key Trial Info
Start Date :
January 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 29 2018
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03380455
Start Date
January 9 2018
End Date
January 29 2018
Last Update
June 2 2022
Active Locations (1)
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1
CRS Clinical Research Services Kiel GmbH
Kiel, Germany, 24105