Clinical trial NCT02526888: Pharmacokinetic Interaction Between Diltiazem and ACT-541468 in Healthy Subjects
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: pharmacokinetic
interaction
Lead sponsor: Idorsia Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2015-08-18
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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

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 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

Primary outcomes:
measure: Maximum plasma concentration (Cmax) of ACT-541468
timeFrame: 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)
measure: Time to reach Cmax of ACT-541468 in plasma
timeFrame: 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
measure: Area under the plasma concentration-time curve (AUC) of ACT-541468
timeFrame: 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)
Secondary outcomes:
Other outcomes:
measure: Incidence of safety events of interest
timeFrame: 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)
measure: Incidence of adverse events
timeFrame: 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)
Locations:
city: Kiel
country: Germany
facility: CRS Clinical Research Services Kiel GmbH
Study officials:
affiliation: Actelion
name: Marie-Laure Boof, PhD
role: STUDY_DIRECTOR
References: