TD-1211 IV/Oral Mass Balance Study

Completed · Phase 1

Conditions studied: OIC

In brief

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

Key facts

Study ID

NCT01702194

Run by

Glycyx Therapeutics

People needed

10

Starts

2012-11-01

Expected to finish

2013-03-01

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older, up to 50. Sex: male. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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.
• Hemoglobin <14.1 g/dL or hematocrit < 40.6% at Screening.
• History of hypersensitivity to drugs, or a history of or any current clinically significant hypersensitivities.
• 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]).
• 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).

Where it is running

• Covance — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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