Single Ascending Dose Study of TD-0714 in Healthy Subjects



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:19 - 55
Updated:4/21/2016
Start Date:November 2015
End Date:February 2016

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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

Single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and
pharmacodynamics of TD-0714 in healthy subjects.


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
1
site
Lincoln, Nebraska 68502
?
mi
from
Lincoln, NE
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