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
Summary
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-541468Time 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
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Male.
Criteria:
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
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