NCT02746237

Single and Multiple Ascending Doses Clinical Pharmacology Study With KAR5585

A Randomized, Double-blind, Placebo-controlled, Phase 1, First-in-human, Single-center, Safety, Tolerability, Ventricular Repolarization and Pharmacokinetic Study of Single and Multiple Ascending Doses of KAR5585 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Karos Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Safety, tolerability, pharmacokinetics (PK), cardiac conduction and food effect study on single and multiple ascending doses of KAR5585 in healthy adults.

Detailed description

The purpose of this study is to explore the safety, tolerability, pharmacokinetics (PK), and cardiac conduction effects of single and multiple ascending doses of KAR5585 in healthy adults. Food effect will also be evaluated after a single-dose administration.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	KAR5585 Capsules	Single and multiple ascending doses of KAR5585 (100 mg initial dose)
DRUG	Placebo Capsules	Single and multiple ascending doses of placebo (100 mg initial dose)

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-05-01
• Completion: 2016-08-01
• First posted: 2016-04-21
• Last updated: 2016-08-30

Locations

1 site across 1 country: United States