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
1 other identifier
interventional
10
1 country
1
Brief Summary
The purpose of this study is to determine TD-1211 is processed by the body.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Nov 2012
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 2, 2012
CompletedFirst Posted
Study publicly available on registry
October 5, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedJanuary 20, 2021
January 1, 2021
3 months
October 2, 2012
January 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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 Outcomes (1)
Number of participants with adverse events
Baseline to 14 days
Study Arms (2)
TD-1211 IV [C14]
EXPERIMENTALTD-1211 IV \[C14\]
TD-1211 PO [C14]
EXPERIMENTALTD-1211 PO \[C14\]
Interventions
Eligibility Criteria
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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Covance
Madison, Wisconsin, 53704, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Theravance Biopharma
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2012
First Posted
October 5, 2012
Study Start
November 1, 2012
Primary Completion
February 1, 2013
Study Completion
March 1, 2013
Last Updated
January 20, 2021
Record last verified: 2021-01