Multiple Ascending Dose Study in Healthy Volunteers
A Phase I Single Center, Double-Blind, Placebo-Controlled, Multiple Dose-Ascending Study to Evaluate the Pharmacokinetics and Tolerability of CTP-730 Immediate Release at Steady State in Healthy Adults
1 other identifier
interventional
30
1 country
1
Brief Summary
This study will assess in healthy male and female subjects the safety, tolerability and pharmacokinetics (PK) profiles of Immediate Release CTP-730 at steady state following 7 days of dosing. Three doses of Immediate Release (IR) CTP-730 capsules will be studied.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Mar 2015
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, 2015
CompletedFirst Submitted
Initial submission to the registry
March 27, 2015
CompletedFirst Posted
Study publicly available on registry
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedFebruary 5, 2016
June 1, 2015
3 months
March 27, 2015
February 3, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Pharmacokinetic Profile
The primary pharmacokinetics parameters of interest will be time to attainment of steady state, and Cmax, Tmax, AUC0-24hr, AUClast and AUCinf at steady state
96 hours
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Adverse events categorized by body system and MedDRA term
24 hours
Study Arms (3)
CTP-730 Low Dose or Matching Placebo
EXPERIMENTALCapsule, once daily.
CTP-730 Mid Dose or Matching Placebo
EXPERIMENTALCapsule, once daily
CTP-730 High Dose or Matching Placebo
EXPERIMENTALCapsule, once daily.
Interventions
Eligibility Criteria
You may qualify if:
- Healthy adult males and females between 18 and 50 years of age.
- Body weight ≥ 50 kg and BMI within the range of 18 to 30 kg/m2
You may not qualify if:
- Medical, psychiatric illness or history of depression that could, in the investigator's opinion, compromise the subject's safety
- Significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- History of clinically significant central nervous system (eg, seizures), cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal (GI) conditions.
- PR interval ≥ 220 msec or QRS duration ≥ 120 msec or QTcB / QTcF interval \> 450 msec obtained at screening visit or prior to the first dose of study drug.
- Liver function tests greater than the upper limit of normal.
- Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, or hepatitis C virus antibody at screening.
- Urinalysis positive for protein or glucose.
- A positive screen for alcohol, drugs of abuse, or tobacco use.
- Inability to comply with food and beverage restrictions during study participation.
- Donation or blood collection or acute loss of blood prior to screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CMAX
Adelaide, South Australia, 5000, Australia
Study Officials
- STUDY DIRECTOR
Ginny Braman
Concert Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2015
First Posted
April 1, 2015
Study Start
March 1, 2015
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
February 5, 2016
Record last verified: 2015-06