Expired Study
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Hackensack, New Jersey 07601


Purpose:

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


Study summary:

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.


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


NCT ID:

NCT01328821


Primary Contact:

Principal Investigator
Gregory Tracey, MD
Frontage Clinical Services


Backup Contact:

N/A


Location Contact:

Hackensack, New Jersey 07601
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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