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
1 other identifier
interventional
38
1 country
1
Brief Summary
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of CTP-499 following single dose administration.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2011
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 30, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedFirst Posted
Study publicly available on registry
April 5, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedOctober 26, 2011
June 1, 2011
1 month
March 30, 2011
October 25, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
5 days
Secondary Outcomes (1)
To assess Pharmacokinetics, Pharmacodynamics and relative bioavailability
2 days
Study Arms (2)
Part A
PLACEBO COMPARATORSingle 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 COMPARATORPart 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.
Interventions
Eligibility Criteria
You may qualify if:
- healthy volunteers
- ages 18 to 55 years old
- nonsmokers
- BMI of 18 to 30 kg/m2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Frontage
Hackensack, New Jersey, 07601, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gregory Tracey, MD
Frontage Clinical Services
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2011
First Posted
April 5, 2011
Study Start
March 1, 2011
Primary Completion
April 1, 2011
Study Completion
June 1, 2011
Last Updated
October 26, 2011
Record last verified: 2011-06