TD-9855 Mass Balance Study
Status: | Completed |
---|---|
Conditions: | Fibromyalgia, Psychiatric, Pain, ADHD |
Therapuetic Areas: | Musculoskeletal, Psychiatry / Psychology, Rheumatology, Other |
Healthy: | No |
Age Range: | 18 - 50 |
Updated: | 11/23/2013 |
Start Date: | October 2013 |
End Date: | December 2013 |
Contact: | Roger Kohler, BA, BS |
Email: | Rkohler@theravance.com |
Phone: | 1.650.808.6401 |
An Open-Label Study to Evaluate the Absorption, Distribution, Metabolism, and Excretion of TD-9855 Following a Single Oral Dose Containing Approximately 100 µCi [14C]-Labeled TD-9855 (20 mg) in Healthy Subjects
The purpose of the study is to evaluate the absorption, distribution, metabolism, and
excretion (ADME) of a single oral dose of [14C]TD-9855
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.
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