Single Ascending Dose Study of TD-0714 in Healthy Subjects
NCT ID: NCT02639078
Last Updated: 2021-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
56 participants
INTERVENTIONAL
2015-11-30
2016-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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TD-0714
One time dosing in capsule formulation
TD-0714
One time dosing in capsule formulation
Placebo
Placebo comparator one time dosing in capsule formulation
Placebo Comparator
One time dosing in capsule formulation
Interventions
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TD-0714
One time dosing in capsule formulation
Placebo Comparator
One time dosing in capsule formulation
Eligibility Criteria
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Inclusion Criteria
* Women of child bearing potential must have a negative pregnancy test and either abstain from sex or use highly effective methods of birth control
* Women of non-childbearing potential are at least 2 years postmenopausal or are surgically sterile
* Males must abstain from sex or use highly effective methods of birth control
* Negative for HIV, and Hepatitis A, B, and C
Exclusion Criteria
* Subjects with a history of angioedema.
* Subject has 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.
* Subject has acute illness (gastrointestinal, infection \[e.g., influenza\] or known inflammatory process)
* Subject bradycardia
* Subject has hypertension
* Subjects has orthostatic hypotension
* Subjects has orthostatic tachycardia
* Subject has a known personal or family history of congenital long QT syndrome or known family history of sudden death.
* Subject has donated blood or blood components or has had blood loss exceeding 400 mL within the 90 days prior to Screening.
19 Years
55 Years
ALL
Yes
Sponsors
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Theravance Biopharma
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Theravance Biopharma
Locations
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Celerion
Lincoln, Nebraska, United States
Countries
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Other Identifiers
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0139
Identifier Type: -
Identifier Source: org_study_id