TD-1211 IV/Oral Mass Balance Study

Phase 1

Completed

• Conditions: OIC
• Interventions: Drug: TD-1211 IV [C14]; Drug: TD-1211 PO [C14]

• Registration Number: NCT01702194
• Lead Sponsor: Theravance Biopharma

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.

Study Timeline

• Study First Submitted: 2012-10-02
• Study First Submitted QC: 2012-10-04
• Study First Posted: 2012-10-05
• Study Start: 2012-11
• Primary Completion: 2013-02
• Study Completion: 2013-03
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-15
• Last Update Posted: 2021-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
TD-1211 IV [C14]	TD-1211 IV [C14]	TD-1211 IV \[C14\]
TD-1211 PO [C14]	TD-1211 PO [C14]	TD-1211 PO \[C14\]

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of participants with adverse events	Baseline to 14 days

Trial Locations

Locations (1)

Covance; 🇺🇸 Madison, Wisconsin, United States