Status:
COMPLETED
A Safety and Tolerability Study of CTP-730 in Healthy Volunteers
Lead Sponsor:
Concert Pharmaceuticals
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
This is a Phase 1, single center, single-ascending dose, randomized study
Detailed Description
Following a Screening period of up to 21 days, eight (8) subjects in each cohort, 6 subjects randomized to CTP-730 and 2 subjects randomized to placebo, will be admitted to the clinical research unit ...
Eligibility Criteria
Inclusion
- Healthy male and female volunteer subjects, 18 to 50 years of age, inclusive.
Exclusion
- Current significant medical condition, laboratory abnormality, or psychiatric illness
- 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
- Elevated liver function tests greater than twice the upper limit of normal
- Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, or hepatitis C virus antibody
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT02239081
Start Date
September 1 2014
End Date
May 1 2015
Last Update
May 29 2015
Active Locations (1)
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1
CMAX
Adelaide, South Australia, Australia, 5000