TD-1211 IV/Oral 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. Identifier: NCT01702194
Recruitment Status : Completed
First Posted : October 5, 2012
Last Update Posted : September 5, 2014
Information provided by (Responsible Party):
Theravance Biopharma Antibiotics, Inc. ( Theravance Biopharma R & D, Inc. )

Brief Summary:
The purpose of this study is to determine TD-1211 is processed by the body.

Condition or disease Intervention/treatment Phase
OIC Drug: TD-1211 IV [C14] Drug: TD-1211 PO [C14] Phase 1

Detailed Description:
This study will provide information regarding the metabolic pathway of TD 1211, the need for evaluation of potential drug-drug interactions, the need for studies in special populations and the absolute oral bioavailability of TD-1211. The administration of radiolabeled drug is necessary to fully characterize the rates and routes of elimination of TD 1211, providing further quantitative information on the disposition of TD 1211. The results from this study will allow a more comprehensive comparison between animal and human routes of elimination and metabolic profiles of TD 1211.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-Dose, Fixed-Sequence, Two-Period, Two−Treatment Study to Evaluate the Absorption, Distribution, Metabolism, and Excretion of TD−1211 Following an Intravenous Infusion and an Oral Dose of [14C]TD−1211 in Healthy Male Subjects
Study Start Date : November 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : March 2013

Arm Intervention/treatment
Experimental: TD-1211 IV [C14]
TD-1211 IV [C14]
Drug: TD-1211 IV [C14]
Other Name: TD-1211
Experimental: TD-1211 PO [C14]
TD-1211 PO [C14]
Drug: TD-1211 PO [C14]
Other Name: TD-1211

Primary Outcome Measures :
  1. Area under the plasma concentration versus time curve (AUC) [ Time Frame: 0 to 168 hours postdose ]
  2. Peak plasma concentration (Cmax) [ Time Frame: 0 to 168 hours postdose ]
  3. Time to peak plasma concentration (Tmax) [ Time Frame: 0 to 168 hours postdose ]
  4. Half-life (T 1/2) [ Time Frame: 0 to 168 hours postdose ]
  5. Percent total recovery of radioactivity in blood, urine, and feces [ Time Frame: 0 to 312 hours postdose ]

Secondary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: Baseline to 14 days ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Healthy, nonsmoking male, 18 to 50 years old, inclusive.
  2. Agrees to use a highly effective method of birth control.
  3. Body mass index (BMI) 19 to 30 kg/m2, inclusive, and weighs at least 55 kg.
  4. Willing and able to give written informed consent.

Exclusion Criteria:

  1. Evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
  2. Hemoglobin <14.1 g/dL or hematocrit < 40.6% at Screening.
  3. History of hypersensitivity to drugs, or a history of or any current clinically significant hypersensitivities.
  4. 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]).
  5. Participated in another clinical trial of an investigational drug (or medical device) within 60 days (or 5 half-lives of the investigational drug, whichever is longer) prior to Screening, or is currently participating in another trial of an investigational drug (or medical device).

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 identifier (NCT number): NCT01702194

United States, Wisconsin
Madison, Wisconsin, United States
Sponsors and Collaborators
Theravance Biopharma R & D, Inc.

Responsible Party: Theravance Biopharma R & D, Inc. Identifier: NCT01702194     History of Changes
Other Study ID Numbers: 0087
First Posted: October 5, 2012    Key Record Dates
Last Update Posted: September 5, 2014
Last Verified: September 2014

Keywords provided by Theravance Biopharma Antibiotics, Inc. ( Theravance Biopharma R & D, Inc. ):
Opioid Induced Constipation