NCT01954615

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

A Single-center, Double-blind, Randomized, Placebo-controlled, Single-ascending Oral Dose and Food Interaction Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT-281959 / ACT-246475 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

Study Part I is a prospective, single-center, double-blind, randomized, placebo-controlled, single-ascending dose, Phase 1 study. Approximately 48 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 are to receive the investigational drug and 2 subjects to receive matching placebo. Study Part II is a prospective, single-center, open-label, randomized, 3-period, crossover, single dose, Phase 1 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

Type	Name	Description
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)

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2013-10-07
• Last updated: 2018-07-10

Locations

1 site across 1 country: France