TD-1211 IV/Oral Mass Balance Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Theravance Biopharma Antibiotics, Inc. ( Theravance Biopharma R & D, Inc. )
ClinicalTrials.gov Identifier:
NCT01702194
First received: October 2, 2012
Last updated: September 3, 2014
Last verified: September 2014
  Purpose

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


Condition Intervention Phase
OIC
Drug: TD-1211 IV [C14]
Drug: TD-1211 PO [C14]
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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

Further study details as provided by Theravance Biopharma Antibiotics, Inc.:

Primary Outcome Measures:
  • Area under the plasma concentration versus time curve (AUC) [ Time Frame: 0 to 168 hours postdose ] [ Designated as safety issue: No ]
  • Peak plasma concentration (Cmax) [ Time Frame: 0 to 168 hours postdose ] [ Designated as safety issue: No ]
  • Time to peak plasma concentration (Tmax) [ Time Frame: 0 to 168 hours postdose ] [ Designated as safety issue: No ]
  • Half-life (T 1/2) [ Time Frame: 0 to 168 hours postdose ] [ Designated as safety issue: No ]
  • Percent total recovery of radioactivity in blood, urine, and feces [ Time Frame: 0 to 312 hours postdose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: Baseline to 14 days ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: November 2012
Study Completion Date: March 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01702194

Locations
United States, Wisconsin
Covance
Madison, Wisconsin, United States
Sponsors and Collaborators
Theravance Biopharma R & D, Inc.
  More Information

No publications provided

Responsible Party: Theravance Biopharma Antibiotics, Inc. ( Theravance Biopharma R & D, Inc. )
ClinicalTrials.gov Identifier: NCT01702194     History of Changes
Other Study ID Numbers: 0087
Study First Received: October 2, 2012
Last Updated: September 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Theravance Biopharma Antibiotics, Inc.:
OIC
Opioid Induced Constipation
Constipation

ClinicalTrials.gov processed this record on October 23, 2014