Single Ascending Dose Study of TD-1439 in Healthy Subjects

Theravance Biopharma

Status and phase

Completed

Phase 1

Conditions

Healthy Subjects

Treatments

Drug: Placebo

Drug: TD-1439

Study type

Interventional

Funder types

Industry

Identifiers

0147

Details and patient eligibility

About

Single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TD-1439 in healthy subjects

Enrollment

66 patients

Sex

All

Ages

19 to 55 years old

Volunteers

Accepts Healthy Volunteers

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