NCT03869320

A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of ACT-1004-1239 in Healthy Male Subjects

A Single-center, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of ACT-1004-1239 in Healthy Male Subjects (Including Food Interaction, Absolute Bioavailability, Mass Balance, and Metabolite Profiling)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This Phase 1 study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses of ACT-1004-1239 in healthy subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ACT-1004-1239	ACT-1004-1239 will be available for clinical study use as hard gelatin capsules for oral administration formulated in strengths of 1, 10, and 100 mg. For the ADME subpart, a single oral dose of 1 μCi of 14C radiolabeled ACT-1004-1239 will be given simultaneously with the ACT-1004-1239 capsule. For the absolute bioavailability subpart, a single intravenous dose of a maximum of 1 μCi of 14C radiolabeled ACT-1004-1239 will be given at the expected tmax after the administration of the ACT-1004-1239 capsule.
OTHER	Placebo	Matching placebo is available as matching capsules for oral administration, formulated with the same excipients but without ACT-1004-1239.
DRUG	ACT-1004-1239 (Food-effect subpart)	ACT-1004-1239 will be available for clinical study use as hard gelatin capsules for oral administration formulated in strengths of 1, 10, and 100 mg.
OTHER	Placebo (Food-effect subpart)	Matching placebo is available as matching capsules for oral administration, formulated with the same excipients but without ACT-1004-1239.

Timeline

• Start date: 2019-03-25
• Primary completion: 2019-07-11
• Completion: 2019-07-11
• First posted: 2019-03-11
• Last updated: 2020-01-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study