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Completed

NCT Number: NCT03814200

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

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

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Key information

Conditions

Healthy Subject

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

QPS Netherlands B.V.

Groningen, 9700, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Saline

Drug

Single i.v. infusion of 100 mL saline 0.9% for 30 min

ACT-246475

Drug

Single s.c. dose of 4 mg ACT-246475 in the thigh under fasting conditions

Other names: Selatogrel

rifampicin

Drug

Single i.v. infusion of 600 mg rifampicin (100 mL) for 30 min

Primary outcomes

  1. 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)

    Time frame: 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

  2. AUC from zero to infinity (AUC0-inf)

    Time frame: 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

  3. The maximum plasma concentration (Cmax)

    Time frame: 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

  4. The time to reach Cmax (tmax)

    Time frame: 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

  5. Terminal half-life (t½)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Viatris Innovation GmbH

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 23, 2019
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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