ADHD, Fibromyalgia
Conditions
Keywords
ADHD, Fibromyalgia
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
Interventions
DRUGTD-9855
radiolabeled (100 µCi \[14C\]-Labeled) TD-9855 (20 mg)
Sponsors
Theravance Biopharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Pharmacokinetics of total drug-related material and TD-9855: Cmax | 1-21 Days | Whole blood and plasma concentrations |
| 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 | — |
| PK: Vz/F (oral volume of distribution during the terminal phase) | 1-21 Days | — |
Countries
United States
Outcome results
None listed