TD-9855 Mass Balance Study

NCT01924143 — Phase 1, Completed, 6 participants, Theravance Biopharma

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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

Registry	NCT01924143
Status	Completed
Phase	Phase 1
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	6 (Actual)
Sponsor	Theravance Biopharma (Industry)
Conditions	ADHD, Fibromyalgia
Interventions	TD-9855 (Drug)
Dates	start 2013-10-01, primary completion 2013-11-01, completion 2013-12-01, first posted 2013-08-16, last updated 2021-01-19
Locations	1 site in United States

-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

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+Arms and interventions

Arm	Type	Interventions	Description
TD-9855	Experimental	Drug: TD-9855

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

+Outcome measures

Primary outcomes

To define the routes and rates of elimination and mass balance of [14C]-labeled TD-9855 [1-21 Days]: Urinary and fecal recovery of total radioactivity. Whole blood and plasma concentrations of total radioactivity.

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 50 Years, 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.

+Locations (1)

Facility	City	Country	Status
	Lincoln, Nebraska	United States

+Investigators

Medical Monitor, Study director, Theravance Biopharma