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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Concert Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01328821

First received: March 30, 2011

Last updated: October 25, 2011

Last verified: June 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

March 30, 2011

Last Updated Date

October 25, 2011

Start Date ^ICMJE

March 2011

Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To assess safety and tolerability of CTP-499 [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01328821 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To assess Pharmacokinetics, Pharmacodynamics and relative bioavailability [ Time Frame: 2 days ] [ Designated as safety issue: No ]

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Diabetic Nephropathy

Intervention ^ICMJE

Drug: CTP-499
600 mg, 1200 mg, 1800 mg and 2400 mg
Drug: CTP-499
400 mg immediate release capsule

Study Arm (s)

Placebo Comparator: Part A
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

Intervention: Drug: CTP-499
Active Comparator: Part B
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.

Intervention: Drug: CTP-499

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2011

Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01328821

Other Study ID Numbers ^ICMJE

CP505.1001 CTP-499

Has Data Monitoring Committee

Responsible Party

Concert Pharmaceuticals

Study Sponsor ^ICMJE

Concert Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Gregory Tracey, MD

Frontage Clinical Services

Information Provided By

Concert Pharmaceuticals

Verification Date

June 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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