TD-6450 SAD and MAD in Healthy Subjects

Theravance Biopharma

Status and phase: Completed; Phase 1

Conditions: Hepatitis C

Treatments: Drug: TD-6450; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02022306

0094

Details and patient eligibility

About

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.

Enrollment: 111 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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111 participants in 3 patient groups, including a placebo group

SAD TD-6450

Placebo Comparator group

Description:

Single ascending dose (Part A)

Treatment:

Drug: TD-6450

Drug: Placebo

MAD TD-6450

Placebo Comparator group

Description:

Multiple ascending dose (Part B)

Treatment:

Drug: TD-6450

Drug: Placebo

Food effect of TD-6450

Active Comparator group

Description:

Food effect will be assessed in Part A (SAD) of this study.

Treatment:

Drug: TD-6450