TD-1211 IV/Oral Mass Balance Study

OIC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01702194
• Other study ID #: 0087
• Status: Completed
• Phase: Phase 1
• Start date: November 2012
• Est. completion date: March 2013

Study information

• Verified date: January 2021
• Source: Theravance Biopharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

• OIC

Intervention

Drug:
• TD-1211 IV [C14]

• TD-1211 PO [C14]

Locations

Country	Name	City	State
United States	Covance	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Theravance Biopharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration versus time curve (AUC)		0 to 168 hours postdose
Primary	Peak plasma concentration (Cmax)		0 to 168 hours postdose
Primary	Time to peak plasma concentration (Tmax)		0 to 168 hours postdose
Primary	Half-life (T 1/2)		0 to 168 hours postdose
Primary	Percent total recovery of radioactivity in blood, urine, and feces		0 to 312 hours postdose
Secondary	Number of participants with adverse events		Baseline to 14 days