NCT04183686

A Study to Examine the Safety, Tolerability, and Pharmacokinetics of Single- and Multiple-ascending Doses of ACT-1014-6470 in Healthy Subjects

Single-center, Double-blind, Randomized, Placebo-controlled Phase 1 Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Single- and Multiple-ascending Doses of ACT-1014-6470 in Healthy Subjects, Including Food Effect, Mass Balance, and Metabolite Profiling

• 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

A study to examine the safety, tolerability, and pharmacokinetics of single- and multiple-ascending doses of ACT-1014-6470 in healthy subjects

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ACT-1014-6470 (SAD)	Single dose of ACT-1014-6470; soft capsules for oral use.
DRUG	ACT-1014-6470 (MAD)	Multiple doses of ACT-1014-6470; soft capsules for oral use.
DRUG	Placebo (SAD)	Single dose of matching placebo; soft capsules for oral use.
DRUG	Placebo (MAD)	Multiple doses of matching placebo; soft capsules for oral use.
DRUG	14C-ACT-1014-6470 microtracer	Single dose of 14C-ACT-1014-6470 microtracer; soft capsules for oral use.
DRUG	14C-ACT-1014-6470 microtracer placebo	Single dose of matching placebo; soft capsules for oral use.

Timeline

• Start date: 2019-11-25
• Primary completion: 2020-03-15
• Completion: 2020-03-15
• First posted: 2019-12-03
• Last updated: 2020-08-12

Locations

1 site across 1 country: Netherlands