TD-9855 Mass Balance Study

Completed · Phase 1

Conditions studied: ADHD, Fibromyalgia

In brief

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

Key facts

Study ID

NCT01924143

Run by

Theravance Biopharma

People needed

6

Starts

2013-10-01

Expected to finish

2013-12-01

Last updated by the study team

2021-01-19

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Study site — Lincoln, Nebraska, United States

Full record on ClinicalTrials.gov

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