TD-9855 Mass Balance Study

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the absorption, distribution, metabolism, and excretion (ADME) of a single oral dose of [14C]TD-9855

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Theravance Biopharma; Theravance Biopharma R & D, Inc.

Criteria

Inclusion Criteria:

• Healthy, nonsmoking male subjects or healthy, nonsmoking female subjects not of childbearing potential, 18 to 50 years old, inclusive. Women are considered to be not of childbearing potential if they have had a hysterectomy or tubal ligation or are at least 2 years postmenopausal (follicle-stimulating hormone [FSH] >40 IU/mL)

• Body mass index 19 to 31 kg/m2, inclusive, and weight at least 55 kg

• Negative for hepatitis B, hepatitis C, and HIV antibody

Exclusion Criteria:

• Have evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, dermatologic, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease

• Subjects who, in the opinion of the investigator, are at risk for suicide or risk of harming others, or who score positive on the C-SSRS (item 2 or higher on ideation). Subjects with any history of suicide attempts

• Any condition possibly affecting drug absorption (e.g., previous surgery on the gastrointestinal tract [including removal of parts of the stomach, bowel, liver, gall bladder, or pancreas])

• Infrequent bowel movements (less than once per 24 hours) in the last 7 days prior to Day -1. Subject is unable to provide a fecal sample prior to study drug dosing on Day -1 or Day 1.