NCT01328821

Safety, Tolerability, and Pharmacokinetics (PK) of CTP-499

A Randomized, Double-blind, Placebo-controlled, Single-ascending-dose, Safety, Tolerability, Pharmacokinetics, and Relative Bioavailability Study of CTP-499 in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Concert Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of CTP-499 following single dose administration.

Detailed description

This is a double-blind, single ascending dose administration study of four doses of CTP-499. Following dosing safety and tolerability will be assessed. Blood and urine samples will be taken for pharmacokinetics (PK) and bioavailability. Safety assessments will include monitoring of adverse events, vital signs (blood pressure, pulse rate, respiratory rate and oral temperature), clinical laboratory findings, 12-lead ECGs, and physical examination findings. The plasma concentration time data for CTP-499 and its metabolites will be analyzed using noncompartmental methods. Actual dosing and sampling times will be used for analysis. The primary pharmacokinetics parameters are: Cmax, Tmax, T1/2, AUClast and AUCinf for plasma; relative bioavailability; and Ae and CLr for urine.

Conditions

• Diabetic Nephropathy

Interventions

Type	Name	Description
DRUG	CTP-499	600 mg, 1200 mg, 1800 mg and 2400 mg
DRUG	CTP-499	400 mg immediate release capsule

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-04-01
• Completion: 2011-06-01
• First posted: 2011-04-05
• Last updated: 2011-10-26

Locations

1 site across 1 country: United States