NCT04798209

A Study to Examine the Safety, Tolerability, and Pharmacokinetics of Single- and Multiple-ascending Doses of ACT-777991 in Healthy Subjects

A 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-777991 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (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-777991 in healthy subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ACT-777991 (SAD)	ACT-777991 administered as hard capsules for oral use.
DRUG	ACT-777991 (MAD)	ACT-777991 administered as hard capsules for oral use, once daily.
DRUG	Placebo (SAD)	ACT-777991 matching placebo administered as hard capsules for oral use.
DRUG	Placebo (MAD)	Matching placebo administered as hard capsules for oral use, once daily.
DRUG	14C-ACT-777991 microtracer (SAD - Absolute Bioavailability)	Single dose of 14C-ACT-777991 microtracer, administered intravenously.
DRUG	Microtracer matching placebo (SAD - Absolute Bioavailability)	Single dose of 14C-ACT-777991 microtracer matching placebo, administered intravenously.
DRUG	14C-ACT-777991 microtracer (MAD - ADME)	Single dose of 14C-ACT-777991 microtracer, oral solution..
DRUG	Microtracer matching placebo (MAD - ADME)	Single dose of 14C-ACT-777991 microtracer matching placebo, oral solution.

Timeline

• Start date: 2021-01-29
• Primary completion: 2022-01-26
• Completion: 2022-05-21
• First posted: 2021-03-15
• Last updated: 2022-06-21

Locations

1 site across 1 country: Netherlands