TD-9855 Mass Balance Study

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

Study Overview

• Status: Completed
• Conditions: Fibromyalgia; ADHD
• Intervention / Treatment: Drug: TD-9855

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68502

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TD-9855	Drug: TD-9855; radiolabeled (100 µCi [14C]-Labeled) TD-9855 (20 mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics of total drug-related material and TD-9855: Cmax	Whole blood and plasma concentrations	1-21 Days
PK: Tmax	Whole blood and plasma concentrations	1-21 Days
PK: AUCt	Whole blood and plasma concentrations	1-21 Days
PK: AUCinf		1-21 Days
PK: CL/F (Renal clearance)	Urine	1-21 Days
PK: Vz/F (oral volume of distribution during the terminal phase)		1-21 Days
PK: amount excreted in urine (Ae)	Urine	1-21 Days
PK: CLR (Renal clearance, computed as amount recovered in urine/ AUCinf)	Urine	8-21 Days
Metabolic profiles in plasma and excreta		1-21 days

Collaborators and Investigators

• Sponsor: Theravance Biopharma

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: August 9, 2013
• First Submitted That Met QC Criteria: August 15, 2013
• First Posted (Estimate): August 16, 2013

Study Record Updates

• Last Update Posted (Actual): January 19, 2021
• Last Update Submitted That Met QC Criteria: January 15, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: ADHD; Fibromyalgia
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: 0105 (CCOP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No