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Single-center, double-blind, randomized, placebo-controlled, single-ascending dose and food interaction study to investigate the tolerability, safety, pharmacokinetics, and pharmacodynamics of ACT-389949 in healthy male subjects

Single-center, double-blind, randomized, placebo-controlled, single-ascending dose and food interaction study to investigate the tolerability, safety, pharmacokinetics, and pharmacodynamics of ACT-389949 in healthy male subjects - ACT-389949

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON35247
Enrollment
64
Registered
2011-11-08
Start date
2011-11-22
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

Acute inflammation

Interventions

n.a.

Sponsors

Actelion Pharmaceuticals
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy Caucasian male subject

Exclusion criteria

Exclusion criteria: Clinically significant abnormalities at screening

Design outcomes

Primary

MeasureTime frame
• to evaluate the safety and tolerability of ascending single oral doses of the test compound ACT-389949 (test medication) in healthy male subjects—

Secondary

MeasureTime frame
• to study how the test compound ACT-389949 is absorbed, broken-down and excreted by the body and how it affects the functioning of the body • to investigate whether increasing the dose of ACT-389949 with a certain proportion results in an increase in the effect of ACT-389949 with that same proportion • to study the impact of food on how a single dose of ACT-389949 is absorbed, broken-down and excreted by the body—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)