NCT02022306CompletedPhase 1
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
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Theravance Biopharma
- Enrollment
- 111
- Locations
- 1
- Primary Endpoint
- Adverse events
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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).
Arms & Interventions
SAD TD-6450
Placebo Comparator
Single ascending dose (Part A)
Intervention: TD-6450 (Drug)
SAD TD-6450
Placebo Comparator
Single ascending dose (Part A)
Intervention: Placebo (Drug)
MAD TD-6450
Placebo Comparator
Multiple ascending dose (Part B)
Intervention: TD-6450 (Drug)
MAD TD-6450
Placebo Comparator
Multiple ascending dose (Part B)
Intervention: Placebo (Drug)
Food effect of TD-6450
Active Comparator
Food effect will be assessed in Part A (SAD) of this study.
Intervention: TD-6450 (Drug)
Outcomes
Primary Outcomes
Adverse events
Time Frame: 28 days max
Secondary Outcomes
- Tmax(28 days max)
- Cmax(28 days max)
- T1/2(28 days max)
- Food effect on AUC value(15 days max)
- AUC(28 days max)
Investigators
Study Sites (1)
Loading locations...
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