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Potential Pharmacokinetic Interaction Between Selexipag and Midazolam in Healthy Male Subjects

Actelion Pharmaceuticals logo

Actelion Pharmaceuticals

Status and phase

Completed
Phase 1

Conditions

Healthy Subjects

Treatments

Drug: Selexipag
Drug: Midazolam

Study type

Interventional

Funder types

Industry

Identifiers

NCT02791815
2016-000856-83 (EudraCT Number)
AC-065-114

Details and patient eligibility

About

The primary purpose of this study is to evaluate the effect of repeated doses of selexipag on the pharmacokinetics of a single oral dose of midazolam (i.e., how long and how much midazolam is present in the blood)

Full description

In order to exclude an inductive effect of selexipag in the gastrointestinal tract, this study aims at investigating the effect of selexipag on the PK of midazolam, a sensitive substrate of both hepatic and intestinal cytochrome P450 3A4 (CYP3A4).

Enrollment

20 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

  • Signed informed consent form
  • Age from 18 to 45 years (inclusive) at screening
  • Body mass index (BMI) from 18.0 to 28.0 kg/m2 (inclusive) at screening
  • Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests

Key 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
  • 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

20 participants in 2 patient groups

Sequence AB
Experimental group
Description:
Subjects participate in two study periods: During the first period, they receive a single oral dose of midazolam on Day 1. During the second period, they receive oral selexipag alone from Day 1 to Day 11 and selexipag + midazolam on Day 12. There is a washout period of 14 to 21 days between the two periods.
Treatment:
Drug: Selexipag
Drug: Midazolam
Sequence BA
Experimental group
Description:
Subjects participate in two study periods: During the first period, they receive oral selexipag alone from Day 1 to Day 11 and selexipag + midazolam on Day 12. During the second period, they receive a single oral dose of midazolam on Day 1. There is a washout period of 14 to 21 days between the two periods.
Treatment:
Drug: Selexipag
Drug: Midazolam

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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