Single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and
pharmacodynamics of TD-0714 in healthy subjects.
Drug: Placebo Comparator
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Locations near you
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Full eligibility criteria for NCT02639078
Ages eligible for Study
19 Years to 55 Years
Genders eligible for Study
Accepts Healthy Volunteers
Body Mass Index (BMI) 18 to 32 kg/m2 inclusive
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
Female subjects who are pregnant, lactating, breastfeeding or planning to become pregnant during the study.
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 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.
Additional exclusion criteria apply
All locations for NCT02639078
United States (1)
Lincoln, Nebraska, United States, 68502
View full eligibility
Tris trial is registered with FDA with number: NCT02639078. The sponsor of the trial is Theravance Biopharma and it is looking for 56 volunteers for the current phase.
Official trial title: A Phase 1, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TD−0714 in Healthy Subjects
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