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

NCT ID: NCT01328821

Last Updated: 2011-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-06-30

Brief Summary

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

Detailed Description

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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

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Diabetic Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type PLACEBO_COMPARATOR

CTP-499

Intervention Type DRUG

600 mg, 1200 mg, 1800 mg and 2400 mg

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.

Group Type ACTIVE_COMPARATOR

CTP-499

Intervention Type DRUG

400 mg immediate release capsule

Interventions

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CTP-499

600 mg, 1200 mg, 1800 mg and 2400 mg

Intervention Type DRUG

CTP-499

400 mg immediate release capsule

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Concert Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gregory Tracey, MD

Role: PRINCIPAL_INVESTIGATOR

Frontage Clinical Services

Locations

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Frontage

Hackensack, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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CP505.1001 CTP-499

Identifier Type: -

Identifier Source: org_study_id