Healthy SubjectsPhase 1NCT02479204
Clinical Study to Investigate Safety and Effects on Heart Rate, Blood Pressure, and Pharmacokinetic Interactions of ACT-334441
A Phase 1 study testing ACT-334441 2 mg, ACT-334441 4 mg and Atenolol in people with Healthy Subjects, run by Viatris Innovation GmbH at 1 site in France.
Trial summary
The aim of the study is to investigate the safety of the concomitant administration of ACT-334441 with cardiovascular drugs. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- ACT-334441 2 mg, ACT-334441 4 mg and Atenolol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 28 Apr 2015to 1 May 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
The aim of the study is to investigate the safety of the concomitant administration of ACT-334441 with cardiovascular drugs.
Read the 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.
- Conditions
- Healthy Subjects
- Being tested
- ACT-334441 2 mg, ACT-334441 4 mg, Placebo, Atenolol, Diltiazem ER
- Keywords
- safety, heart rate, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
AtenololDrug
Also called Tenormine
film-coated tablet containing atenolol at a strength of 50 mg
Diltiazem ERDrug
Also called Bi-tildiem
film-coated tablet containing diltiazem at a strength of of 120 mg
| Study group | Role | What they receive |
|---|---|---|
| Part A ACT-334441 + atenolol | Experimental | 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 Receives: Drug: ACT-334441 2 mg; Drug: Atenolol |
| Part A ACT-334441 + diltiazem | Experimental | 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 Receives: Drug: ACT-334441 2 mg; Drug: Diltiazem ER |
| Part B ACT-334441 + atenolol | Experimental | 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 Receives: Drug: ACT-334441 4 mg; Drug: Placebo; Drug: Atenolol |
| Part B ACT-334441 + diltiazem | Experimental | 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 Receives: Drug: ACT-334441 4 mg; Drug: Placebo; Drug: Diltiazem ER |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Days 1 and 6 (Part A); Days 1, 6, 8, 9, 15, and 16 (Part B
Secondary outcomes (6)
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)
Measured: 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
Measured: 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
Measured: 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 required for the plasma concentration of a drug to decrease by 50% in the final stage of its elimination
Measured: 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)
Ctrough will be used to determine the attainment of steady state conditions
Measured: 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
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
Measured: From baseline to end of study [Day 20-23 (Part A), Day 556-59 (Part B)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study start28 Apr 2015
- Primary completion1 May 2016
- Study completion1 May 2016
Why it stopped: Based on results from the pilot phase, the study is terminated. No safety events leading to discontinuation were reported
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viatris Innovation GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Viatris Innovation GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02479204
- Sponsor's protocol ID
- AC-064-102
- Status last verified
- Jul 2018
- First submitted
- 17 Jun 2015
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02479204
- Acronym / sponsor ID
- AC-064-102
- Conditions
- Healthy Subjects
- Keywords
- safety, heart rate, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Based on results from the pilot phase, the study is terminated. No safety events leading to discontinuation were reported
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Viatris Innovation GmbHIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2015 (actual)
- Primary completion
- 1 May 2016 (actual)
- Study completion
- 1 May 2016 (actual)
- First posted
- 24 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to investigate the safety of the concomitant administration of ACT-334441 with cardiovascular drugs.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A ACT-334441 + atenolol | Experimental | Drug: ACT-334441 2 mg, Drug: Atenolol4 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 |
| Part A ACT-334441 + diltiazem | Experimental | Drug: ACT-334441 2 mg, Drug: Diltiazem ER4 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 |
| Part B ACT-334441 + atenolol | Experimental | Drug: ACT-334441 4 mg, Drug: Placebo, Drug: Atenolol12 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 |
| Part B ACT-334441 + diltiazem | Experimental | Drug: ACT-334441 4 mg, Drug: Placebo, Drug: Diltiazem ER12 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 |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT-334441 2 mgcapsule containing ACT-334441 at a strength of 2 mg | Drug | Part A ACT-334441 + atenolol, Part A ACT-334441 + diltiazem |
| ACT-334441 4 mgcapsule containing ACT-334441 at a strength of 4 mg | Drug | Part B ACT-334441 + atenolol, Part B ACT-334441 + diltiazem |
| PlaceboACT-33441-matching placebo | Drug | Part B ACT-334441 + atenolol, Part B ACT-334441 + diltiazem |
| AtenololAlso: Tenorminefilm-coated tablet containing atenolol at a strength of 50 mg | Drug | Part A ACT-334441 + atenolol, Part B ACT-334441 + atenolol |
| Diltiazem ERAlso: Bi-tildiemfilm-coated tablet containing diltiazem at a strength of of 120 mg | Drug | Part A ACT-334441 + diltiazem, Part B ACT-334441 + diltiazem |
Primary outcome
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
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
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
6 secondary outcomes
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.
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.
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
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
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
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)]
Results and safety
The study was stopped early (reason given: Based on results from the pilot phase, the study is terminated. No safety events leading to discontinuation were reported). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Viatris Innovation GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ACT-334441 2 mg, ACT-334441 4 mg and Atenolol in people with Healthy Subjects, run by Viatris Innovation GmbH at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Based on results from the pilot phase, the study is terminated. No safety events leading to discontinuation were reported). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.