Healthy Subject
Conditions
Brief summary
The study will investigate the effect of rifampicin on the uptake and breakdown of ACT-246475 in healthy subjects
Interventions
DRUGSaline
Single i.v. infusion of 100 mL saline 0.9% for 30 min
DRUGACT-246475
Single s.c. dose of 4 mg ACT-246475 in the thigh under fasting conditions
DRUGRifampicin
Single i.v. infusion of 600 mg rifampicin (100 mL) for 30 min
Sponsors
Viatris Innovation GmbH
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Netherlands
Outcome results
None listed