NCT02126956

Mass Balance, Pharmacokinetics, and Metabolism of 14C-labeled ACT-128800 Administered to Healthy Male Subjects

Single-center, Open-label Study With 14C-labeled ACT-128800 to Investigate the Mass Balance, Pharmacokinetics, and Metabolism Following Single Oral Administration to Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Actelion · Industry
• Sex: Male
• Age: 45 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The study was conducted to investigate the metabolism and mass balance of ACT-128800, and to identify the elimination pathways (metabolism and excretion) of ACT-128800 and compare them with the known metabolic profiles of ACT-128800 in animals.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	ACT-128800	ACT-128800 was supplied as a powder mix in hard gelatin capsules for oral administration. The capsules contained a co-precipitated mixture of non-radiolabeled and 14C-labeled ACT-128800 formulated at a dose strength of 40 mg with a maximum radioactive content of 102 μCi (3.79 MBq).

Timeline

• Start date: 2009-03-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2014-04-30
• Last updated: 2014-04-30

Locations

1 site across 1 country: Switzerland