Text Size

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
  Purpose

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


Condition Intervention Phase
Diabetic Nephropathy
 Drug: CTP-499
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Single-ascending-dose, Safety, Tolerability, Pharmacokinetics, and Relative Bioavailability Study of CTP-499 in Healthy Adults

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Concert Pharmaceuticals:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.



Enrollment: 38
Study Start Date: March 2011
Study Completion Date: June 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01328821

Locations
United States, New Jersey
Frontage
Hackensack, New Jersey, United States, 07601
Sponsors and Collaborators
Concert Pharmaceuticals
Investigators
Principal Investigator: Gregory Tracey, MD Frontage Clinical Services
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Concert Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01328821     History of Changes
Other Study ID Numbers: CP505.1001 CTP-499
Study First Received: March 30, 2011
Last Updated: October 25, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Concert Pharmaceuticals:
Safety
Tolerability
Pharmacokinetics
Healthy volunteers

Additional relevant MeSH terms:
Diabetic Nephropathies
Kidney Diseases
Urologic Diseases
 Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013