Skip to main content
OpenTrials
Completed

NCT Number: NCT02526888

Pharmacokinetic Interaction Between Diltiazem and ACT-541468 in Healthy Subjects

The main objective of this study is to investigate whether repeated administration of a cardiac medication (diltiazem) can affect the pharmacokinetics (i.e., amount and time of presence in the blood) of ACT-541468

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Subjects

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

CRS Clinical Research Services Kiel GmbH

Kiel, 24105, Germany

About this study

Because ACT-541468 appears to be mainly metabolized by CYP3A4, it is deemed of interest to investigate the potential influence of diltiazem, a well-known CYP3A4 inhibitor on the pharmacokinetic profile of ACT-541468.

Safety of the concomitant administration of the two drugs will also be assessed

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed informed consent
  • Body mass index (BMI) between 18.0 and 28.0 kg/m2 (inclusive) at screening
  • Healthy on the basis of physical examination,cardiovascular assessments and laboratory tests

Exclusion criteria

  • 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
  • History of narcolepsy or cataplexy or modified Swiss narcolepsy scale total score < 0
  • 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

Treatment and study plan

ACT-541468

Drug

Oral capsule (25 mg) as single dose

Diltiazem

Drug

Two oral capsules (2 x 120 mg) once daily from Day 1 to Day 7

Primary outcomes

  1. Maximum plasma concentration (Cmax) of ACT-541468

    Time frame: From baseline to end of study (Day 8 after last study drug intake for sequence AB, Day 5 after last study drug intake for sequence BA)

    Cmax will be directly derived from the plasma concentration time curves of ACT-541468

  2. Time to reach Cmax of ACT-541468 in plasma

    Time frame: From baseline to end of study (Day 8 after last study drug intake for sequence AB, Day 5 after last study drug intake for sequence BA

    tmax will be directly derived from the plasma concentration time curves of ACT-541468

  3. Area under the plasma concentration-time curve (AUC) of ACT-541468

    Time frame: From baseline to end of study (Day 8 after last study drug intake for sequence AB, Day 5 after last study drug intake for sequence BA)

    AUC will be calculated for the following time frame: from time zero to the last measured concentration above the limit of quantification and from time zero to infinitiy

Other outcomes

  1. Incidence of safety events of interest

    Time frame: From baseline to end of study (Day 8 after last study drug intake for sequence AB, Day 5 after last study drug intake for sequence BA)

    Events of interest are any abnormalities in ECG, vital signs or laboratory test results

  2. Incidence of adverse events

    Time frame: From baseline to end of study (Day 8 after last study drug intake for sequence AB, Day 5 after last study drug intake for sequence BA)

    Number of participants with any adverse events, including laboratory abnormalities

Sponsors and collaborators

Lead sponsor

Idorsia Pharmaceuticals Ltd.

Industry

Registry information

Official study title

A Single-center, Open-label, Randomized, Two-way Crossover Study to Investigate the Effect of Multiple-dose Diltiazem on the Pharmacokinetics of a Single Dose of 25 mg ACT-541468 in Healthy Male Subjects

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 18, 2015
Registry last updated
Jul 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.