NCT02381496

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)

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

Part A of this study is a single-center, randomized, double-blind, placebo-controlled, single-ascending dose (SAD) design in healthy male subjects. In each cohort, eight subjects will be randomized as follows: * Six male subjects will receive a single oral dose of ACT-453859, under fasted conditions. * Two male subjects will receive matching placebo, under fasted conditions. The doses of ACT-453859 were 1, 3, 10, 30, 100, 300, and 800 mg. Subjects in only one cohort (100 mg dose cohort) will come back for a second period of treatment under fed conditions. Part B is a single-center, randomized, double-blind, placebo-controlled multiple-ascending dose (MAD) design in healthy male and female of subjects. In each of 3 cohorts, eight subjects will be randomized to receive multiple doses of ACT-453859 or placebo once a day for 7 days as follows: * Three male subjects will receive ACT-453859. * Three female subjects will receive ACT-453859. * One male subject will receive matching placebo. * One female subject will receive matching placebo. The doses of ACT-453859 will be 10, 100, and 800 mg per day. Part C is a single-center and open-label design consisting of multiple oral doses of setipiprant given in a sequential design in healthy male and female subjects. Eight subjects will be randomized to receive multiple doses of setipiprant for 7 days (only a single dose on Day 7), in Treatment Period I (TPI) and Treatment Period II (TPII), as follows: * Four male subjects will receive setipiprant 500 mg twice a day (b.i.d.) in TPI and 1000 mg b.i.d. in TPII. * Four female subjects will receive setipiprant 500 mg b.i.d. in TPI and 1000 mg b.i.d. in TPII.

Conditions

• Healthy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2015-03-06
• Last updated: 2018-07-10