Single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and
pharmacodynamics of TD-1439 in healthy subjects
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Locations near you
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Full eligibility criteria for NCT02903095
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
- 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
- Subject has acute illness (gastrointestinal, infection [e.g., influenza] or known
- 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.
- Additional exclusion criteria apply
All locations for NCT02903095
United States (1)
Lincoln, Nebraska, United States, 68502
View full eligibility
Tris trial is registered with FDA with number: NCT02903095. The sponsor of the trial is Theravance Biopharma and it is looking for 66 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-1439 in Healthy Subjects
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