Pharmacokinetic Interaction Between Diltiazem and ACT-541468 in Healthy Subjects

Idorsia Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Diltiazem; Drug: ACT-541468

Study type: Interventional

Funder types: Industry

Identifiers

NCT02526888

AC-078-103

Details and patient eligibility

About

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

Full 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

Enrollment: 14 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Sequence AB

Experimental group

Description:

During Period 1, subjects receive a single dose of ACT-541468 on Day 1. During Period 2, they receive Diltiazem from Day 1 to Day 7 and a single dose of ACT-541468 on Day 4

Treatment:

Drug: ACT-541468

Drug: Diltiazem

Sequence BA

Experimental group

Description:

During Period 1, subjects receive Diltiazem from Day 1 to Day 7 and a single dose of ACT-541468 on Day 4. During Period 2, they receive a single dose of ACT-541468 on Day 1

Treatment:

Drug: ACT-541468

Drug: Diltiazem