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TD-9855 Mass Balance Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01924143
Recruitment Status : Completed
First Posted : August 16, 2013
Last Update Posted : January 19, 2021
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
ADHD Fibromyalgia Drug: TD-9855 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Experimental: TD-9855 Drug: TD-9855
radiolabeled (100 µCi [14C]-Labeled) TD-9855 (20 mg)




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


Secondary Outcome Measures :
  1. Pharmacokinetics of total drug-related material and TD-9855: Cmax [ Time Frame: 1-21 Days ]
    Whole blood and plasma concentrations

  2. PK: Tmax [ Time Frame: 1-21 Days ]
    Whole blood and plasma concentrations

  3. PK: AUCt [ Time Frame: 1-21 Days ]
    Whole blood and plasma concentrations

  4. PK: AUCinf [ Time Frame: 1-21 Days ]
  5. PK: CL/F (Renal clearance) [ Time Frame: 1-21 Days ]
    Urine

  6. PK: Vz/F (oral volume of distribution during the terminal phase) [ Time Frame: 1-21 Days ]
  7. PK: amount excreted in urine (Ae) [ Time Frame: 1-21 Days ]
    Urine

  8. PK: CLR (Renal clearance, computed as amount recovered in urine/ AUCinf) [ Time Frame: 8-21 Days ]
    Urine

  9. Metabolic profiles in plasma and excreta [ Time Frame: 1-21 days ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01924143


Locations
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United States, Nebraska
Lincoln, Nebraska, United States, 68502
Sponsors and Collaborators
Theravance Biopharma
Investigators
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Study Director: Medical Monitor Theravance Biopharma
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Responsible Party: Theravance Biopharma
ClinicalTrials.gov Identifier: NCT01924143    
Other Study ID Numbers: 0105
First Posted: August 16, 2013    Key Record Dates
Last Update Posted: January 19, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Theravance Biopharma:
ADHD
Fibromyalgia
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases