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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Pharmacokinetic Profile
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Arms & Interventions
CTP-730 High Dose or Matching Placebo
Capsule, once daily.
Intervention: Placebo for CTP-730 (Drug)
CTP-730 Low Dose or Matching Placebo
Capsule, once daily.
Intervention: CTP-730 (Drug)
CTP-730 Low Dose or Matching Placebo
Capsule, once daily.
Intervention: Placebo for CTP-730 (Drug)
CTP-730 Mid Dose or Matching Placebo
Capsule, once daily
Intervention: CTP-730 (Drug)
CTP-730 Mid Dose or Matching Placebo
Capsule, once daily
Intervention: Placebo for CTP-730 (Drug)
CTP-730 High Dose or Matching Placebo
Capsule, once daily.
Intervention: CTP-730 (Drug)
Outcomes
Primary Outcomes
Pharmacokinetic Profile
Time Frame: 96 hours
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
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: 24 hours
Adverse events categorized by body system and MedDRA term
Secondary Outcomes
No secondary outcomes reported