TD-1211 IV/Oral Mass Balance Study

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01702194

Enrollment

Registered

2012-10-05

Start date

2012-11-01

Completion date

2013-03-01

Last updated

2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

OIC

Keywords

OIC, Opioid Induced Constipation, Constipation

Brief summary

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

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.

Interventions

DRUGTD-1211 IV [C14]

DRUGTD-1211 PO [C14]

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 Years

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).

Design outcomes

Primary

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

Secondary

Measure	Time frame
Number of participants with adverse events	Baseline to 14 days

Countries

United States

Contacts

STUDY_DIRECTORMedical Monitor

Theravance Biopharma

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026