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

Phase 1

Completed

• Conditions: Diabetic Nephropathy
• Interventions: Drug: CTP-499

• Registration Number: NCT01328821
• Lead Sponsor: Concert Pharmaceuticals

Brief 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.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-30
• Primary Completion: 2011-04
• Study First Submitted QC: 2011-04-04
• Study First Posted: 2011-04-05
• Status Verified: 2011-06
• Study Completion: 2011-06
• Last Update Submitted: 2011-10-25
• Last Update Posted: 2011-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• healthy volunteers
• ages 18 to 55 years old
• nonsmokers
• BMI of 18 to 30 kg/m2

Exclusion Criteria

• Significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders of drug hypersensitivity
• Systolic Blood pressure < 90 or > 140, diastolic bp > 90

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Part B	CTP-499	Part B will consist of a single 400 mg dose of an immediate release capsule of CTP-499 administered under fasting conditions. In Part B 6 subjects will be enrolled.
Part A	CTP-499	Single ascending dose administration of four doses of CTP-499 as tablets under fasting condition. 8 subjects per dose group will be enrolled with a 3:1 randomization of active drug to placebo. Dose levels: 600mg -\> 1200mg -\> 1800mg -\> 2400mg

Primary Outcome Measures

Name	Time	Method
To assess safety and tolerability of CTP-499	5 days	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. Safety data will be summarized using descriptive statistics for all subjects who receive at least 1 dose. Adverse events will be summarized by frequency. Abnormal laboratory and physical exam findings will be summarized by dose and treatment.

Secondary Outcome Measures

Name	Time	Method
To assess Pharmacokinetics, Pharmacodynamics and relative bioavailability	2 days	Pharmacokinetics: individual and mean concentration time profiles will be presented graphically. Alll PK parameters will be summarized by dose group using descriptive statistics (eg n, arithmetic mean, SD, geometric mean, median, CV). Relative bioavailability will be estimated using the geometric mean values of dose normalized AUC for each dose.; Pharmacodynamics: From the 12 lead ECG data, VR, PR, QRS, QT, QTcF andd QTcB will be reported for each time point and summarized using descriptive statistics. Mean temporal profiles for 12 lead ECG and vital signs will be presented graphically.

Trial Locations

Locations (1)

Frontage; 🇺🇸 Hackensack, New Jersey, United States