Trials Sponsors Conditions Drugs Pricing

Conditions

Healthy Subjects

Keywords

safetyheart ratepharmacokinetics

Outcome Measures

Primary Outcomes (3)

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
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
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
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)
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)
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)
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)
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)
From Day 1 to Day 15 for diltiazem and atenolol; from Day 8 to Day 15 for ACT-33444

Other Outcomes (1)

Lymphocyte count as a measure of immunomodulation (Part A + Part B)
Day 1, Day 6, Day 12 and Day 20 (Part A); Day 1 and Day 8 toDay 16 (Part B)

Study Arms (4)

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

Drug: ACT-334441 2 mgDrug: 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

Drug: ACT-334441 2 mgDrug: Diltiazem ER

Part B ACT-334441 + atenolol

EXPERIMENTAL

Interventions

ACT-334441 2 mgDrug

capsule containing ACT-334441 at a strength of 2 mg

Part A ACT-334441 + atenololPart A ACT-334441 + diltiazem

ACT-334441 4 mgDrug

capsule containing ACT-334441 at a strength of 4 mg

Part B ACT-334441 + atenolol

Eligibility Criteria

Age25 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Signed informed consent
Body mass index (BMI) between 18.0 and 30.0 kg/m2 (inclusive) at screening.

Sponsors & Collaborators

Viatris Innovation GmbH
Industrylead

Study Sites (1)

BIOTRIAL

Rennes, CS 34246, France

MeSH Terms

Interventions

Atenolol

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAmines

Study Officials

Clinical Trials
Viatris Innovation GmbH
STUDY DIRECTOR

Enrollment

10 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: OTHER
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 17, 2015

First Posted

June 24, 2015

Study Start

April 28, 2015

Actual (reported)

Primary Completion

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (6)

Other Outcomes (1)

Study Arms (4)

Part A ACT-334441 + atenolol

Part A ACT-334441 + diltiazem

Part B ACT-334441 + atenolol

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Part B ACT-334441 + diltiazem

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (6)

Other Outcomes (1)

Study Arms (4)

Part A ACT-334441 + atenolol

Part A ACT-334441 + diltiazem

Part B ACT-334441 + atenolol

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Part B ACT-334441 + diltiazem

You may not qualify if:

Source record

Locations