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TD-9855 Mass Balance Study

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Theravance Biopharma

Status and phase

Completed
Phase 1

Conditions

Fibromyalgia
ADHD

Treatments

Drug: TD-9855

Study type

Interventional

Funder types

Industry

Identifiers

NCT01924143
0105 (Other Identifier)

Details and patient eligibility

About

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

Enrollment

6 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

6 participants in 1 patient group

TD-9855
Experimental group
Treatment:
Drug: TD-9855

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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