Clinical Study to Investigate Safety and Effects on Heart Rate, Blood Pressure, and Pharmacokinetic Interactions of ACT-334441

• Status: Terminated
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to investigate the safety of the concomitant administration of ACT-334441 with cardiovascular drugs.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Actelion; Idorsia Pharmaceuticals Ltd.
• Treatments: Atenolol; Calcium Channel Blockers; Diltiazem

Criteria

Inclusion Criteria:

• Signed informed consent

• Body mass index (BMI) between 18.0 and 30.0 kg/m2 (inclusive) at screening.

• Women of childbearing potential must have a negative pregnancy test and they must use reliable methods of contraception

• Healthy on the basis of physical examination,cardiovascular assessments and laboratory tests

Exclusion Criteria:

• Pregnant or lactating women

• Any contraindication to the study drugs

• History or presence of any disease or condition or treatment, which may put the subject at risk of participation in the study or may interfere with the absorption, distribution, metabolism or excretion of the study drugs

• Any clinically significant abnormalities in laboratory tests, vital signs, ECG variables and pulmonary variables

• Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol