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

September 16, 2025 updated by: Viatris Innovation GmbH

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France, CS 34246
        • Biotrial

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part A ACT-334441 + atenolol
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
Drug: ACT-334441 2 mg
capsule containing ACT-334441 at a strength of 2 mg
Drug: Atenolol
film-coated tablet containing atenolol at a strength of 50 mg
Other Names:
  • Tenormine
Experimental: Part A ACT-334441 + diltiazem
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
Drug: ACT-334441 2 mg
capsule containing ACT-334441 at a strength of 2 mg
Drug: Diltiazem ER
film-coated tablet containing diltiazem at a strength of of 120 mg
Other Names:
  • Bi-tildiem
Experimental: Part B ACT-334441 + atenolol
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
Drug: Atenolol
film-coated tablet containing atenolol at a strength of 50 mg
Other Names:
  • Tenormine
Drug: ACT-334441 4 mg
capsule containing ACT-334441 at a strength of 4 mg
Drug: Placebo
ACT-33441-matching placebo
Experimental: Part B ACT-334441 + diltiazem
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
Drug: Diltiazem ER
film-coated tablet containing diltiazem at a strength of of 120 mg
Other Names:
  • Bi-tildiem
Drug: ACT-334441 4 mg
capsule containing ACT-334441 at a strength of 4 mg
Drug: Placebo
ACT-33441-matching placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
PR intervals measured by 12-lead ECG (Part A + Part B)
Time Frame: Days 1 and 6 (Part A); Days 1, 6, 8, 9, 15, and 16 (Part B)
Absolute PR intervals and corresponding changes from baseline at the different days of measurement
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)
Time Frame: Days 1 and 6 (Part A); Days 1, 6, 8, 9, 15, and 16 (Part B)
Absolute heart rates at the different days of measurement
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
Time Frame: Days 1 and 6 (Part A); Days 1, 6, 8, 9, 15, and 16 (Part B
Absolute and change from baseline in hourly mean HR on each day of measurement
Days 1 and 6 (Part A); Days 1, 6, 8, 9, 15, and 16 (Part B

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Areas under the plasma concentration-time curves (AUC) for ACT-334441, diltiazem and atenolol (Part B)
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.
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)
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)
Time Frame: From Day 1 to Day 20 for diltiazem and atenolol; from Day 8 to Day 21 for ACT-33444.
The measured individual concentrations of ACT-334441, diltiazem and atenolol will be used to obtain their respective Cmax
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)
Time Frame: From Day 1 to Day 20 for diltiazem and atenolol; from Day 8 to Day 21 for ACT-33444
The measured individual concentrations of ACT-334441, diltiazem and atenolol will be used to obtain their respective tmax
From Day 1 to Day 20 for diltiazem and atenolol; from Day 8 to Day 21 for ACT-33444
Terminal half-life [t(1/2)] of ACT-334441, diltiazem and atenolol (Part B)
Time Frame: From Day 1 to Day 20 for diltiazem and atenolol; from Day 8 to Day 21 for ACT-33444
Time required for the plasma concentration of a drug to decrease by 50% in the final stage of its elimination
From Day 1 to Day 20 for diltiazem and atenolol; from Day 8 to Day 21 for ACT-33444
Trough plasma levels (Ctrough) of of ACT-334441, diltiazem and atenolol (Part B)
Time Frame: From Day 1 to Day 15 for diltiazem and atenolol; from Day 8 to Day 15 for ACT-33444
Ctrough will be used to determine the attainment of steady state conditions
From Day 1 to Day 15 for diltiazem and atenolol; from Day 8 to Day 15 for ACT-33444
Number of subjects with adverse events as a measure of safety
Time Frame: From baseline to end of study [Day 20-23 (Part A), Day 556-59 (Part B)]
An AE is defined as any unfavorable and unintended sign, including an abnormal laboratory finding, symptom or disease, that occurs during the course of the study, whether or not considered related to the study drug
From baseline to end of study [Day 20-23 (Part A), Day 556-59 (Part B)]

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Lymphocyte count as a measure of immunomodulation (Part A + Part B)
Time Frame: Day 1, Day 6, Day 12 and Day 20 (Part A); Day 1 and Day 8 toDay 16 (Part B)
Day 1, Day 6, Day 12 and Day 20 (Part A); Day 1 and Day 8 toDay 16 (Part B)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Viatris Innovation GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Viatris Innovation GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 28, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2015

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AC-064-102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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