A Safety and Tolerability Study of CTP-730 in Healthy Volunteers

Study Overview
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Brief Summary
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This is a Phase 1, single center, single-ascending dose, randomized study

Detailed Description
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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 (CRU) on the evening before dosing and remain sequestered at the study site until after the last inpatient blood sample is collected at 48 hours.

Official Title
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A Randomized, Double-blind, Single Ascending Dose, Safety, Tolerability, Pharmacokinetics Study of CTP-730 in Healthy Volunteers

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 male and female volunteer subjects, 18 to 50 years of age, inclusive. Exclusion Criteria: 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

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: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CTP-730, 5 mg<br>oral suspension, once daily. | Drug: CTP-730<br> <br> Drug: Placebo for CTP-730<br> <br> |
| Experimental: CTP-730, 10 mg<br>Oral Suspension, once daily. | Drug: CTP-730<br> <br> Drug: Placebo for CTP-730<br> <br> |
| Experimental: CTP-730, 20 mg<br>Oral Suspension, once daily. | Drug: CTP-730<br> <br> Drug: Placebo for CTP-730<br> <br> |
| Experimental: CTP-730, 30 mg<br>Oral Suspension, once daily. | Drug: CTP-730<br> <br> Drug: Placebo for CTP-730<br> <br> |
| Experimental: CTP-730, 40 mg<br>Oral Suspension, once daily. | Drug: CTP-730<br> <br> Drug: Placebo for CTP-730<br> <br> |
| Experimental: CTP-730, 50 mg<br>Oral Suspension, once daily. | Drug: CTP-730<br> <br> Drug: Placebo for CTP-730<br> <br> |
| Experimental: CTP-730, 60 mg<br>Oral Suspension, 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 |
| --- | --- | --- |
| Number and severity of adverse events |  | 3 days | 
| Pharmacokinetics parameters | Peak plasma concentration - Cmax by dose Area under the plasma concentration by time - AUC by dose | 96 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics, Safety