A Study to Investigate the Effect of Rifampicin on the Uptake and Breakdown of ACT-246475 in Healthy Subjects
- Registration Number
- NCT03814200
- Lead Sponsor
- Idorsia Pharmaceuticals Ltd.
- Brief Summary
The study will investigate the effect of rifampicin on the uptake and breakdown of ACT-246475 in healthy subjects
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
- Signed informed consent in a language understandable to the subject prior to any study-mandated procedure
- Healthy male and female subjects aged between 18 and 65 years (inclusive) at Screening
- Body mass index of 18.0 to 30.0 kg/m2 (inclusive) at Screening
- Systolic blood pressure 100-145 mmHg, diastolic blood pressure 50-90 mmHg, and pulse rate 45-90 bpm (inclusive), measured on the same arm, after 5 min in the supine position at screening and on Day -1 of the first period
- Hematology and coagulation test results not deviating from the normal range to a clinically relevant extent at Screening and on Day -1 of the first period
- Women of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day- 1 of the first treatment period and must agree to consistently and correctly use a highly effective method of contraception
- Previous exposure to ACT-246475.
- Previous exposure to rifampicin within 3 months prior to Screening.
- Known hypersensitivity to P2Y12 receptor antagonists or rifampicin, or to any of the rifamycins, or any of their excipients
- Loss of 250 mL or more of blood within 3 months prior to Screening
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
- Family or personal history of prolonged bleeding (e.g., after surgical intervention) or bleeding disorders (e.g., thrombocytopenia, clotting disturbances), intracranial vascular diseases, stroke, reasonable suspicion of vascular malformations, or peptic ulcers
- Known platelet disorders (e.g., Glanzmann thromboasthenia, von Willebrand disease, platelet release defect)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment period A Saline Treatment A1: saline 0.9% followed by Treatment A2: ACT-246475 Treatment period B Rifampicin Treatment B1: rifampicin followed by Treatment B2: ACT-246475 Treatment period A ACT-246475 Treatment A1: saline 0.9% followed by Treatment A2: ACT-246475 Treatment period B ACT-246475 Treatment B1: rifampicin followed by Treatment B2: ACT-246475
- Primary Outcome Measures
Name Time Method Area under the plasma concentration-time curve (AUC) from time zero to time t of the last measured concentration above the limit of quantification (AUC0-t) Up to 36 hours after treatment administration The plasma PK parameters of ACT-246475 will be derived by non-compartmental analysis of the plasma concentration-time profiles
AUC from zero to infinity (AUC0-inf) Up to 36 hours after treatment administration The plasma PK parameters of ACT-246475 will be derived by non-compartmental analysis of the plasma concentration-time profiles
The maximum plasma concentration (Cmax) Up to 36 hours after treatment administration The plasma PK parameters of ACT-246475 will be derived by non-compartmental analysis of the plasma concentration-time profiles
The time to reach Cmax (tmax) Up to 36 hours after treatment administration The plasma PK parameters of ACT-246475 will be derived by non-compartmental analysis of the plasma concentration-time profiles
Terminal half-life (t½) Up to 36 hours after treatment administration The plasma PK parameters of ACT-246475 will be derived by non-compartmental analysis of the plasma concentration-time profiles
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
QPS Netherlands B.V.
🇳🇱Groningen, Netherlands