DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Drug Interaction Study of ACT-334441 With Cardiovascular Medications in Healthy Subjects

Information source: Actelion
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Subjects

Intervention: ACT-334441 2 mg (Drug); ACT-334441 4 mg (Drug); placebo (Drug); atenolol (Drug); diltiazem ER (Drug)

Phase: Phase 1

Status: Suspended

Sponsored by: Actelion


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

Clinical Details

Official title: Single-center, Open-label, Randomized, Multiple-dose, Parallel-group Study to Investigate Safety and Effects on Heart Rate, Blood Pressure, and Pharmacokinetic Interactions of ACT-334441 Combined With Calcium-channel Blocker (Diltiazem) or Beta-blocker (Atenolol) Treatment in Healthy Subjects

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Primary outcome:

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

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

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

Secondary outcome:

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

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

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

Terminal half-life [t(1/2)] of ACT-334441, diltiazem and atenolol (Part B)

Trough plasma levels (Ctrough) of of ACT-334441, diltiazem and atenolol (Part B)

Number of subjects with adverse events as a measure of safety

Detailed 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.


Minimum age: 25 Years. Maximum age: 55 Years. Gender(s): Both.


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 and Contacts

BIOTRIAL, Rennes CS 34246, France
Additional Information

Starting date: May 2015
Last updated: August 12, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017