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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01328821
Recruitment Status : Completed
First Posted : April 5, 2011
Last Update Posted : October 26, 2011
Information provided by (Responsible Party):
Concert Pharmaceuticals

March 30, 2011
April 5, 2011
October 26, 2011
March 2011
April 2011   (Final data collection date for primary outcome measure)
To assess safety and tolerability of CTP-499 [ Time Frame: 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.
Same as current
Complete list of historical versions of study NCT01328821 on Archive Site
To assess Pharmacokinetics, Pharmacodynamics and relative bioavailability [ Time Frame: 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.

Same as current
Not Provided
Not Provided
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
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of CTP-499 following single dose administration.

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.

Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetic Nephropathy
  • Drug: CTP-499
    600 mg, 1200 mg, 1800 mg and 2400 mg
  • Drug: CTP-499
    400 mg immediate release capsule
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
June 2011
April 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
CP505.1001 CTP-499
Not Provided
Not Provided
Concert Pharmaceuticals
Concert Pharmaceuticals
Not Provided
Principal Investigator: Gregory Tracey, MD Frontage Clinical Services
Concert Pharmaceuticals
June 2011

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