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

Phase 1TerminatedNCT02479204

Viatris Innovation GmbH10 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy Subjects

Interventions

ACT-334441 2 mgDRUG

capsule containing ACT-334441 at a strength of 2 mg

ACT-334441 4 mgDRUG

capsule containing ACT-334441 at a strength of 4 mg

PlaceboDRUG

ACT-33441-matching placebo

Atenolol

Eligibility

Sex: ALLMin age: 25 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

BIOTRIAL

Rennes, France

Outcomes

Primary Outcomes

PR intervals measured by 12-lead ECG (Part A + Part B)

Absolute PR intervals and corresponding changes from baseline at the different days of measurement

Time frame: Days 1 and 6 (Part A); Days 1, 6, 8, 9, 15, and 16 (Part B)

Heart rate (HR) measured by 12-lead ECG (PArt A + Part B)

Absolute heart rates at the different days of measurement

Time frame: Days 1 and 6 (Part A); Days 1, 6, 8, 9, 15, and 16 (Part B)

Hourly mean heart rate (HR) measured by 24-hour Holter ECG

Absolute and change from baseline in hourly mean HR on each day of measurement

Time frame: Days 1 and 6 (Part A); Days 1, 6, 8, 9, 15, and 16 (Part B

Secondary Outcomes

Areas under the plasma concentration-time curves (AUC) for ACT-334441, diltiazem and atenolol (Part B)

AUCs will be calculated will be calculated according to the linear trapezoidal rule for the following periods: from zero to time t of the last measured concentration above the limit of quantification, from zero to 24h after study drug administration, from zero to infinity)

Time frame: Blood samples from Day 1 to Day 20 for the PK profile of diltiazem and atenolol, and from Day 8 to Day 21 for the PK profile of ACT-334441.

Maximum plasma concentration (Cmax) for ACT-334441, diltiazem and atenolol (Part B)

The measured individual concentrations of ACT-334441, diltiazem and atenolol will be used to obtain their respective Cmax

Time frame: From Day 1 to Day 20 for diltiazem and atenolol; from Day 8 to Day 21 for ACT-33444.

Time to reach the maximum plasma concentration (tmax) for ACT-334441, diltiazem and atenolol (Part B)

The measured individual concentrations of ACT-334441, diltiazem and atenolol will be used to obtain their respective tmax

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.