TD-9855 Mass Balance Study

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

Official Title
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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

Conditions
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ADHD, Fibromyalgia

Intervention / Treatment
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* Drug: TD-9855


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, Fibromyalgia