Safety, Tolerability, and Pharmacokinetics (PK) of CTP-499
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of CTP-499 following single dose administration.
|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|
- 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.
- 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.
|Study Start Date:||March 2011|
|Study Completion Date:||June 2011|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
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
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.
400 mg immediate release capsule
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.
|United States, New Jersey|
|Hackensack, New Jersey, United States, 07601|
|Principal Investigator:||Gregory Tracey, MD||Frontage Clinical Services|