Multiple Ascending Dose Study in Healthy Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: CTP-730
* Drug: Placebo for CTP-730


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CTP-730 Low Dose or Matching Placebo<br>Capsule, once daily. | Drug: CTP-730<br> <br> Drug: Placebo for CTP-730<br> <br> |
| Experimental: CTP-730 Mid Dose or Matching Placebo<br>Capsule, once daily | Drug: CTP-730<br> <br> Drug: Placebo for CTP-730<br> <br> |
| Experimental: CTP-730 High Dose or Matching Placebo<br>Capsule, once daily. | Drug: CTP-730<br> <br> Drug: Placebo for CTP-730<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety/Efficacy Study, Randomized, Double Blind