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Pharmacokinetic Interaction Between Diltiazem and ACT-541468 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

Intervention: ACT-541468 (Drug); Diltiazem (Drug)

Phase: Phase 1

Status: Not yet recruiting

Sponsored by: Actelion

Overall contact:
CTD clinical trials disclosure desk, Email: clinical-trials-disclosure@actelion.com


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

Clinical Details

Official 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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome:

Maximum plasma concentration (Cmax) of ACT-541468

Time to reach Cmax of ACT-541468 in plasma

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

Detailed description: 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


Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Male.


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

Locations and Contacts

CTD clinical trials disclosure desk, Email: clinical-trials-disclosure@actelion.com

CRS Clinical Research Services Kiel GmbH, Kiel 24105, Germany; Not yet recruiting
CTD Clinical Trial Disclosure Desk, Email: clinical-trials-disclosure@actelion.com
Additional Information

Starting date: September 2015
Last updated: August 17, 2015

Page last updated: August 23, 2015

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