A Clinical Study to Investigate the Potential Interactions Between Food and ACT-541468 and Between ACT-541468 and Midazolam

NCT ID: NCT03017495

Last Updated: 2018-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2017-02-01

Brief Summary

The main objectives of this phase 1 trial are to evaluate the effect of food on the pharmacokinetics (i.e. how long and how much a compound is present in the blood) of ACT-541468 and to evaluate whether ACT-541468 can affect the pharmacokinetics of midazolam, a CYP3A4 substrate.

Detailed Description

Food effect will be assessed by comparing the pharmacokinetic (PK) parameters of a single dose of ACT-541468 under fasted (Treatment B) and fed (Treatment C) conditions.

Potential CYP3A4 inhibiting / inducing effects of ACT-541468 will be assessed by comparing the PK parameters of midazolam alone (Treatment A) and midazolam given with a single dose of ACT-541468 (Treatment B) or with multiple doses of ACT-541468 (Treatment D).

Conditions

Healthy Subjects

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Food effect and Drug-Drug interaction

Treatments will be given to all subjects in the same fixed sequence: Treatment A (Day 1, single dose of midazolam, fasted), Treatment B (Day 2, single dose of ACT-541468 followed by single dose of midazolam, fasted), Treatment C (Day 4, single dose ACT-541468, fed), Treatment D (multiple doses of ACT-541468 from Day 5 to Day 8 + single dose of midazolam on Day 8, fasted).

Group Type: EXPERIMENTAL

Midazolam

Intervention Type: DRUG

2 mg/mL oral solution

ACT-541468

Intervention Type: DRUG

Hard gelatin capsules for oral use at a strength of 25 mg

Interventions

Midazolam

2 mg/mL oral solution

Intervention Type: DRUG

ACT-541468

Hard gelatin capsules for oral use at a strength of 25 mg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Signed informed consent form
• Male subjects aged from 18 to 45 years (inclusive) at screening
• Body mass index (BMI) from 18.0 to 30.0 kg/m2 (inclusive) at screening
• Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests

Exclusion Criteria

• Any contraindication to the study treatments
• History or clinical evidence of any disease or medical / surgical 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 treatments
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Idorsia Pharmaceuticals Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie-Laure Boof, PhD

Role: STUDY_DIRECTOR

Actelion

Locations

Investigator Site

Kiel, , Germany

Countries

Germany

Other Identifiers

2016-003490-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AC-078-104

Identifier Type: -

Identifier Source: org_study_id