Status:
COMPLETED
A Study to Investigate the Effect of Rifampicin on the Uptake and Breakdown of ACT-246475 in Healthy Subjects
Lead Sponsor:
Viatris Innovation GmbH
Conditions:
Healthy Subject
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The study will investigate the effect of rifampicin on the uptake and breakdown of ACT-246475 in healthy subjects
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 19 2019
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03814200
Start Date
January 3 2019
End Date
February 19 2019
Last Update
July 3 2025
Active Locations (1)
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1
QPS Netherlands B.V.
Groningen, Netherlands, 9700