TD-1211 IV/Oral Mass Balance Study

May 19, 2026 updated by: Glycyx Therapeutics

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53704
        • Covance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TD-1211 IV [C14]
Drug: TD-1211 IV [C14]
Other Names:
  • TD-1211
Experimental: TD-1211 PO [C14]
Drug: TD-1211 PO [C14]
Other Names:
  • TD-1211

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events
Time Frame: Baseline to 14 days
Baseline to 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glycyx Therapeutics

Investigators

  • Study Director: Medical Monitor, Theravance Biopharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

October 2, 2012

First Submitted That Met QC Criteria

October 4, 2012

First Posted (Estimated)

October 5, 2012

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0087

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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