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.

Completed

• Conditions: Acute myocardial infarction; heart attack; 10028593

• Registration Number: NL-OMON46064
• Lead Sponsor: Idorsia Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 14

Inclusion Criteria

Healthy male and female subjects aged between 18 and 65 years (inclusive) with a Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) at Screening.;Further inclusion criteria can be found in the protocol section 3.2.2

Exclusion Criteria

1. Previous exposure to ACT-246475.
2. Previous exposure to rifampicin within 3 months prior to Screening.
3. Known hypersensitivity to P2Y12 receptor antagonists or rifampicin or to any of the rifamycins, or any of their excipients. ;Further exclusion criteria can be found in the protocol section 3.2.3.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The pharmacokinetic parameters</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The safety endpoint parameters are frequency and severity of adverse events,<br /><br>vital signs, electrocardiography (ECG), safety laboratory tests and urinalysis. </p><br>