TD-6450 SAD and MAD in Healthy Subjects

Study Overview
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Brief Summary
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This study consists of two parts, Parts A and B. Part A is a single ascending dose (SAD) study in healthy subjects. Part B is a multiple ascending dose (MAD) study in healthy subjects.

Official Title
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A Double-Blinded, Randomized, Placebo-Controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of TD-6450, a NS5A Inhibitor, in Healthy Subjects

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: TD-6450
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is a female of non-childbearing potential or male, who is healthy, nonsmoking, and 18 to 60 years old, inclusive, at screening. Females are considered to be of non childbearing potential if they have had a hysterectomy or tubal ligation (documentation required) or are postmenopausal (amenorrheic for at least 2 years) with a follicle stimulating hormone (FSH) level >40 IU/L Subject has a body mass index 18 to 30 kg/m2, inclusive, and weighs at least 50 kg. Exclusion Criteria: Subject has evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease. Subject has an estimated creatinine clearance of <90 mL/min at Screening or Day -1, calculated using the Cockcroft-Gault equation. Subject has participated in another clinical trial of an investigational drug (or medical device) within 60 days prior to Screening, or is currently participating in another trial of an investigational drug (or medical device).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: SAD TD-6450<br>Single ascending dose (Part A) | Drug: TD-6450<br> <br> Drug: Placebo<br> <br> |
| Placebo Comparator: MAD TD-6450<br>Multiple ascending dose (Part B) | Drug: TD-6450<br> <br> Drug: Placebo<br> <br> |
| Active Comparator: Food effect of TD-6450<br>Food effect will be assessed in Part A (SAD) of this study. | Drug: TD-6450<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | 28 days max | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Pharmacokinetics | 28 days max | 
| Tmax | Pharmacokinetics | 28 days max | 
| AUC | Pharmacokinetics | 28 days max | 
| T1/2 | Pharmacokinetics | 28 days max | 
| Food effect on AUC value | Measure difference between fasted and fed doses | 15 days max | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C