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

Concert Pharmaceuticals38 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Diabetic Nephropathy

Interventions

CTP-499DRUG

600 mg, 1200 mg, 1800 mg and 2400 mg

CTP-499DRUG

400 mg immediate release capsule

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Frontage

Hackensack, New Jersey, United States

Outcomes

Primary Outcomes

To assess safety and tolerability of CTP-499

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.

Time frame: 5 days

Secondary Outcomes

To assess Pharmacokinetics, Pharmacodynamics and relative bioavailability

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.

Time frame: 2 days

Data from ClinicalTrials.gov

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