Macitentan Phase 1 study

Macitentan Phase 1 study in Japanese healthy male subjects (clinical pharmacokinetics study)

Status

Unknown

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222838

Enrollment

Registered

2015-04-28

Start date

2015-04-28

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Japanese healthy male subjects

Interventions

investigational material(s) Generic name etc : ACT-064992 INN of investigational material : Macitentan Therapeutic category code : 219 Other cardiovascular agents Dosage and Administration for Investi

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Signed and dated written informed consent prior to enrollment in the study Healthy Japanese adult males Body mass index (BMI) ≥ 18 and ≤ 28 kg/m2 at screening. BMI = weight (kg) / [height (m)]2

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
1.Tolerability, Safety 2.Pharmacokinetics (macitentan and active metabolite) 1.Adverse event. Change from baseline to each time point of measurement for vital sign, ECG, laboratory test and body weight. 2.Pharmacokinetics (macitentan and active metabolite)	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026