NCT02099201

Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT-389949 in Healthy Subjects

A Single-center, Double-blind, Parallel-group, Randomized, Placebo-controlled, Multiple-ascending Oral Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT-389949 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This is a single-center, double-blind, parallel-group, randomized, placebo-controlled, multiple-ascending oral dose study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ACT-389949 in healthy subjects. Part A of the study will evaluate the safety and tolerability following once a day oral dosing of ACT-389949 for 9 days and investigate ACT-389949 pharmacokinetics and pharmacodynamics. Part B of the study will evaluate the safety and tolerability of ACT-389949 following a maximum of two different oral dosing regimens: ACT-389949 given either every 3 days for 13 days or every 2 days for 9 days (5 doses for each regimen). Part C of the study, if required, will provide additional information to that obtained from Parts A and B in terms of safety, tolerability, pharmacokinetics, and pharmacodynamics of ACT-389949.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	ACT-389949 40 mg
DRUG	ACT-389949 200 mg	Predicted dose
DRUG	ACT-389949 800 mg	Predicted dose
DRUG	ACT-389949 (Group C1 dose to be selected)
DRUG	ACT-389949 (Group C2 dose to be selected)
DRUG	Placebo

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2014-03-28
• Last updated: 2018-07-10

Locations

1 site across 1 country: United Kingdom