Trial | NCT01328821  Report issue

Title

Safety, Tolerability, and Pharmacokinetics (PK) of CTP-499
A Randomized, Double-blind, Placebo-controlled, Single-ascending-dose, Safety, Tolerability, Pharmacokinetics, and Relative Bioavailability Study of CTP-499 in Healthy Adults

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    ctp-499 ...

  • Study Participants

    38
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 Started
Mar 31
2011
Primary Completion
Apr 30
2011
Study Completion
Jun 30
2011
Last Update
Oct 26
2011
Estimate

Drug CTP-499

600 mg, 1200 mg, 1800 mg and 2400 mg

Drug CTP-499

400 mg immediate release capsule

Part A Placebo Comparator

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

Part B Active Comparator

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.

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
No Results Posted