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A Study to Assess the Tolerability, Safety, Pharmacodynamics, and Pharmacokinetics of Ascending Single Doses (Including Food Interaction) and Ascending Multiple Doses of ACT-453859, and Multiple Doses of Setipiprant (ACT-129968)

NCT02381496 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2018-07-10

No results posted yet for this study

Summary

This is a three-part study to assess the tolerability, safety, pharmacodynamics, and pharmacokinetics of ascending single doses (including food interaction) of ACT-453859 in healthy male subjects, of ascending multiple doses of ACT-453859 in healthy male and female subjects, and of multiple doses of setipiprant (ACT-129968) in healthy male and female subjects.

Conditions

  • Healthy

Interventions

DRUG

ACT-453859 1 mg

Capsule

DRUG

ACT-453859 3 mg

Capsule

DRUG

ACT-453859 10 mg

Capsule

DRUG

ACT-453859 30mg

Capsule

DRUG

ACT-453859 100 mg

Capsule

DRUG

ACT-453859 300 mg

Capsule

DRUG

ACT-453859 800 mg

Capsule

OTHER

Placebo

Matching ACT-453859 placebo capsule

DRUG

Setipiprant 500 mg

Capsule

DRUG

Setipiprant 1000 mg

Capsule

Sponsors & Collaborators

  • Idorsia Pharmaceuticals Ltd.

    lead INDUSTRY

Principal Investigators

  • Martine Géhin, PhD · Actelion

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2012-04-30
Completion
2012-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02381496 on ClinicalTrials.gov