TD-9855 Mass Balance Study

Phase 1

Completed

• Conditions: ADHD; Fibromyalgia
• Interventions: Drug: TD-9855

• Registration Number: NCT01924143
• Lead Sponsor: Theravance Biopharma

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-09
• Study First Submitted QC: 2013-08-15
• Study First Posted: 2013-08-16
• Study Start: 2013-10
• Primary Completion: 2013-11
• Study Completion: 2013-12
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-15
• Last Update Posted: 2021-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TD-9855	TD-9855	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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: amount excreted in urine (Ae)	1-21 Days	Urine
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: CLR (Renal clearance, computed as amount recovered in urine/ AUCinf)	8-21 Days	Urine
Metabolic profiles in plasma and excreta	1-21 days