Phase I study to assess the pharmacokinetics and pharmacodynamics of macitentan in Korean healthy male subjects

A double-blind, randomized, placebo-controlled, phase I study to assess the tolerability, safety, pharmacokinetics, and pharmacodynamics of repeated daily doses of 3, 10 and 30mg of macitentan in Korean healthy male subjects

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0000326

Enrollment

Registered

2012-01-20

Start date

2012-02-01

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Macitentan (3 mg, 10 mg, 30 mg) or placebo will be orally administered once daily for 10 days.

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Healthy Korean adult males 2. Aged 20 to 50 years, inclusive, at screening 3. Healthy on the basis of medical history and the assessments performed at screening

Exclusion criteria

Exclusion criteria: 1. History of clinically relevant hypersensitivity or serious adverse reactions to any drug 2. Abnormal values that suggest a clinically significant underlying disease or subject with the following lab abnormalities: 1)Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 1.25 × the upper limits of normal 2)Total bilirubin > 1.5 × the upper limits of normal

Design outcomes

Primary

Measure	Time frame
Cmax;tmax;Ctrough;AUC0-24;t½;Accumulation index (R)	—

Countries

Korea, Republic of

Contacts

Public ContactJung-hoon Kim

Actelion Pharmaceuticals Korea

Outcome results