A Study to Investigate the Effect of Rifampicin on the Uptake and Breakdown of ACT-246475 in Healthy Subjects

Study Overview
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Brief Summary
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The study will investigate the effect of rifampicin on the uptake and breakdown of ACT-246475 in healthy subjects

Official Title
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A Single-center, Randomized, Double-blind, Two-period Cross-over Study to Investigate the Effect of a Single Intravenous Dose of Rifampicin on the Pharmacokinetics of ACT-246475 in Healthy Subjects

Conditions
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Healthy Subject

Intervention / Treatment
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* Drug: Saline
* Drug: ACT-246475
* Drug: Rifampicin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment period A<br>Treatment A1: saline 0.9% followed by Treatment A2: ACT-246475 | Drug: Saline<br>* Single i.v. infusion of 100 mL saline 0.9% for 30 min<br>Drug: ACT-246475<br>* Single s.c. dose of 4 mg ACT-246475 in the thigh under fasting conditions<br>* Other names: Selatogrel;|
| Experimental: Treatment period B<br>Treatment B1: rifampicin followed by Treatment B2: ACT-246475 | Drug: ACT-246475<br>* Single s.c. dose of 4 mg ACT-246475 in the thigh under fasting conditions<br>* Other names: Selatogrel;Drug: Rifampicin<br>* Single i.v. infusion of 600 mg rifampicin (100 mL) for 30 min<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | The plasma PK parameters of ACT-246475 will be derived by non-compartmental analysis of the plasma concentration-time profiles | Up to 36 hours after treatment administration | 
| AUC from zero to infinity (AUC0-inf) | The plasma PK parameters of ACT-246475 will be derived by non-compartmental analysis of the plasma concentration-time profiles | Up to 36 hours after treatment administration | 
| The maximum plasma concentration (Cmax) | The plasma PK parameters of ACT-246475 will be derived by non-compartmental analysis of the plasma concentration-time profiles | Up to 36 hours after treatment administration | 
| The time to reach Cmax (tmax) | The plasma PK parameters of ACT-246475 will be derived by non-compartmental analysis of the plasma concentration-time profiles | Up to 36 hours after treatment administration | 
| Terminal half-life (t½) | The plasma PK parameters of ACT-246475 will be derived by non-compartmental analysis of the plasma concentration-time profiles | Up to 36 hours after treatment administration |