NCT01475981

Safety, Tolerability and Pharmacokinetics Study Assessing Ascending Single Oral JTK-853 Doses in Healthy Subjects

Randomized,Double-blind,Placebo-controlled,Ascending Dose Part Evaluating Safety,Tolerability and Pharmacokinetics (PK) of JTK-853 (Fasted/Fed) and Randomized,Open-label,Crossover Part Evaluating Food Effect on PK in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Akros Pharma Inc. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study was to determine the safety, tolerability and pharmacokinetics of ascending single oral doses of JTK-853 administered under fasted or fed conditions in healthy male subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	JTK-853 or Placebo	Tablets, single dose, fasted, fed or high-fat fed condition

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2011-11-22
• Last updated: 2011-11-22

Locations

1 site across 1 country: United States