Back to resultsTD-9855 Mass Balance Study
Primary Purpose
ADHD, Fibromyalgia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TD-9855
Sponsored by
About this trial
This is an interventional treatment trial for ADHD focused on measuring ADHD, Fibromyalgia
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TD-9855
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Pharmacokinetics of total drug-related material and TD-9855: Cmax
Whole blood and plasma concentrations
PK: Tmax
Whole blood and plasma concentrations
PK: AUCt
Whole blood and plasma concentrations
PK: AUCinf
PK: CL/F (Renal clearance)
Urine
PK: Vz/F (oral volume of distribution during the terminal phase)
PK: amount excreted in urine (Ae)
Urine
PK: CLR (Renal clearance, computed as amount recovered in urine/ AUCinf)
Urine
Metabolic profiles in plasma and excreta
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01924143
Brief Title
TD-9855 Mass Balance Study
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
October 2013 (Actual)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theravance Biopharma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD, Fibromyalgia
Keywords
ADHD, Fibromyalgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TD-9855
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
TD-9855
Intervention Description
radiolabeled (100 µCi [14C]-Labeled) TD-9855 (20 mg)
Primary Outcome Measure Information:
Title
To define the routes and rates of elimination and mass balance of [14C]-labeled TD-9855
Description
Urinary and fecal recovery of total radioactivity. Whole blood and plasma concentrations of total radioactivity.
Time Frame
1-21 Days
Secondary Outcome Measure Information:
Title
Pharmacokinetics of total drug-related material and TD-9855: Cmax
Description
Whole blood and plasma concentrations
Time Frame
1-21 Days
Title
PK: Tmax
Description
Whole blood and plasma concentrations
Time Frame
1-21 Days
Title
PK: AUCt
Description
Whole blood and plasma concentrations
Time Frame
1-21 Days
Title
PK: AUCinf
Time Frame
1-21 Days
Title
PK: CL/F (Renal clearance)
Description
Urine
Time Frame
1-21 Days
Title
PK: Vz/F (oral volume of distribution during the terminal phase)
Time Frame
1-21 Days
Title
PK: amount excreted in urine (Ae)
Description
Urine
Time Frame
1-21 Days
Title
PK: CLR (Renal clearance, computed as amount recovered in urine/ AUCinf)
Description
Urine
Time Frame
8-21 Days
Title
Metabolic profiles in plasma and excreta
Time Frame
1-21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Theravance Biopharma
Official's Role
Study Director
Facility Information:
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68502
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
Learn more about this trial
TD-9855 Mass Balance Study
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