TD-9855 Mass Balance Study

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01924143
• Other study ID #: 0105
• Status: Completed
• Phase: Phase 1
• Start date: October 2013
• Est. completion date: December 2013

Study information

• Verified date: January 2021
• Source: Theravance Biopharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• ADHD
• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• TD-9855
radiolabeled (100 µCi [14C]-Labeled) TD-9855 (20 mg)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Theravance Biopharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To define the routes and rates of elimination and mass balance of [14C]-labeled TD-9855	Urinary and fecal recovery of total radioactivity. Whole blood and plasma concentrations of total radioactivity.	1-21 Days
Secondary	Pharmacokinetics of total drug-related material and TD-9855: Cmax	Whole blood and plasma concentrations	1-21 Days
Secondary	PK: Tmax	Whole blood and plasma concentrations	1-21 Days
Secondary	PK: AUCt	Whole blood and plasma concentrations	1-21 Days
Secondary	PK: AUCinf		1-21 Days
Secondary	PK: CL/F (Renal clearance)	Urine	1-21 Days
Secondary	PK: Vz/F (oral volume of distribution during the terminal phase)		1-21 Days
Secondary	PK: amount excreted in urine (Ae)	Urine	1-21 Days
Secondary	PK: CLR (Renal clearance, computed as amount recovered in urine/ AUCinf)	Urine	8-21 Days
Secondary	Metabolic profiles in plasma and excreta		1-21 days