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

Viatris Innovation GmbH

Status and phase: Terminated; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: ACT-334441 4 mg; Drug: Placebo; Drug: ACT-334441 2 mg; Drug: Atenolol; Drug: Diltiazem ER

Study type: Interventional

Funder types: Industry

Identifiers

NCT02479204

AC-064-102

Details and patient eligibility

About

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

Full description

The study will consist of two parts: a pilot part (Part A) that will be completed prior to the start of the main part (Part B). The Subjects who will participate in Part A are excluded from Part B.

Enrollment: 10 patients

Sex: All

Ages: 25 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 4 patient groups

Part A ACT-334441 + atenolol

Experimental group

Description:

4 subjects will receive 50 mg of atenolol once daily for 6 days, and a concomitant single administration of ACT-334441 2 mg on Day 6

Treatment:

Drug: Atenolol

Drug: ACT-334441 2 mg

Part A ACT-334441 + diltiazem

Experimental group

Description:

4 subjects will receive 240 mg of diltiazem once daily for 6 days, and a concomitant single administration of ACT-334441 2 mg on Day 6

Treatment:

Drug: Diltiazem ER

Drug: ACT-334441 2 mg

Part B ACT-334441 + atenolol

Experimental group

Description:

12 subjects will receive 50 mg of atenolol (once daily) from day 1 to day 15, placebo once on day 6, and ACT-334441 4 mg (once daily) from day 8 to day 15

Treatment:

Drug: Atenolol

Drug: Placebo

Drug: ACT-334441 4 mg

Part B ACT-334441 + diltiazem

Experimental group

Description:

12 subjects will receive 240 mg of diltiazem (once daily) from day 1 to day 15, placebo once on day 6, and ACT-334441 4 mg (once daily) from day 8 to day 15

Treatment:

Drug: Diltiazem ER

Drug: Placebo

Drug: ACT-334441 4 mg