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Single-ascending Oral Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT-281959 / ACT-246475 in Healthy Male Subjects

NCT01954615 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2018-07-10

No results posted yet for this study

Summary

Study Part I is a single-ascending dose study. Healthy male subjects to be included in the study and randomized in 6 dose groups, Groups A-F (8 subjects per group). Of the 8 subjects per group, 6 subjects receive the investigational drug and 2 subjects receive matching placebo. Study Part II is a 3-period, crossover, single dose study. Nine healthy male subjects to be enrolled in one group (Group G). Each subject to receive 2 different formulations of the prodrug and one formulation of the active drug in a randomized sequence.

Conditions

  • Safety, Tolerability, Pharmacokinetics and Pharmacodynamics

Interventions

DRUG

5 mg ACT-281959 prodrug formulation I (Group A)

DRUG

20 mg ACT-281959 prodrug formulation I (Group B)

DRUG

ACT-281959 prodrug formulation I (Groups C to G doses to be defined)

DRUG

ACT-281959 prodrug formulation II (Group G dose to be defined)

DRUG

ACT-246475 (Group G dose to be defined)

DRUG

Placebo (Groups A to F)

Sponsors & Collaborators

  • Idorsia Pharmaceuticals Ltd.

    lead INDUSTRY

Principal Investigators

  • Daniela Baldoni, PharmD PhD · Actelion

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • France

Study Locations

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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 NCT01954615 on ClinicalTrials.gov