TD-1211 IV/Oral Mass Balance Study

Theravance Biopharma

Status and phase: Completed; Phase 1

Conditions: OIC

Treatments: Drug: TD-1211 PO [C14]; Drug: TD-1211 IV [C14]

Study type: Interventional

Funder types: Industry

Identifiers

NCT01702194

0087

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

TD-1211 IV [C14]

Experimental group

Description:

TD-1211 IV \[C14\]

Treatment:

Drug: TD-1211 IV [C14]

TD-1211 PO [C14]

Experimental group

Description:

TD-1211 PO \[C14\]

Treatment:

Drug: TD-1211 PO [C14]