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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-03

Study Completion Date

2019-02-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Evaluate the Effect of Rifampicin on the Pharmacokinetics of Abiraterone in Healthy Male Participants

NCT01655147

Healthy

COMPLETED PHASE1

A Study to Evaluate the Effect of Rifampin on the Single-dose Pharmacokinetics (PK) of BMS-986141 in Healthy Subjects

NCT02957448

Atherothrombotic Diseases

COMPLETED PHASE1

A Study to Assess the Effect of Rifampin on the Pharmacokinetics of PCI-32765 in Healthy Participants

NCT01763021

Healthy Participants

COMPLETED PHASE1

A Study to Investigate the Effect of Rifampicin on the PK of Multiple Doses of Balovaptin In Healthy Volunteers

NCT03586726

Healthy Volunteers

COMPLETED PHASE1

Effects of Rifampin on the Pharmacokinetics of Nilotinib in Healthy Subjects

NCT00418756

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Subject

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment period A

Treatment A1: saline 0.9%

followed by

Treatment A2: ACT-246475

Group Type EXPERIMENTAL

Saline

Intervention Type DRUG

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

ACT-246475

Intervention Type DRUG

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

Treatment period B

Treatment B1: rifampicin

followed by

Treatment B2: ACT-246475

Group Type EXPERIMENTAL

ACT-246475

Intervention Type DRUG

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

Rifampicin

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Saline

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

Intervention Type DRUG

ACT-246475

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

Intervention Type DRUG

Rifampicin

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Selatogrel

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes