Single Ascending Dose Study of TD-1439 in Healthy Subjects
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy Subjects
In brief
Single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TD-1439 in healthy subjects
Key facts
- Study ID
- NCT02903095
- Run by
- Theravance Biopharma
- People needed
- 66
- Starts
- 2016-09-01
- Expected to finish
- 2017-02-01
- Last updated by the study team
- 2021-01-19
Who can join
Age: 19 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 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
Where it is running
- Celerion — Lincoln, Nebraska, United States
Full record on ClinicalTrials.gov
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