Recent Updates
Recently added Catalysts

TD-1439

Phase 1

Healthy Adults, Elderly Subjects | Small molecule | Other |Theravance Biopharma, Inc.|Last Updated: Jan 20, 2021

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

TD-1439 · 2 trials · 2 indications

Phase 1 2
NCT02954263Multiple Ascending Dose Study of TD-1439 in Healthy Adult and Elderly SubjectsHealthy Adults, Elderly Subjects
COMPLETED40 Analytics
NCT02903095Single Ascending Dose Study of TD-1439 in Healthy SubjectsHealthy Subjects
COMPLETED66 Analytics
PHASE1COMPLETED
Multiple Ascending Dose Study of TD-1439 in Healthy Adult and Elderly Subjects
Healthy Adults, Elderly SubjectsUnlock trial analytics
PHASE1COMPLETED
Single Ascending Dose Study of TD-1439 in Healthy Subjects
Healthy SubjectsUnlock trial analytics

Study Endpoints

Primary Endpoints

The number of adverse events by severity, including changes in vital signs, physical examination, laboratory safety tests, and ECGs.
From Day 1 through end of study (Day 25)
Safety of TD-1439 by assessing the number and severity of adverse events, including changes in vital signs, physical examination, laboratory safety tests, and ECGs
From Day 1 through end of study (Day 10)

Secondary Endpoints

Pharmacokinetics (PK) of TD-1439 in plasma after multiple doses - peak plasma concentration (Cmax)
Day 1 to 3 days after last dose (Day 17)
PK of TD-1439 in plasma after multiple doses - time to peak plasma concentration (Tmax)
Day 1 to 3 days after last dose (Day 17)
PK of TD-1439 in plasma after multiple doses - time to last measurable concentration (Tlast)
Day 1 to 3 days after last dose (Day 17)
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
TD-1439EXPERIMENTALCapsule formulation
PlaceboPLACEBO_COMPARATORCapsule formulation

Interventions

NameTypeDescription
TD-1439DRUG -
PlaceboDRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range19 Years to 80 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 s...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about TD-1439

What is TD-1439?

TD-1439 is an investigational small molecule being developed by Theravance Biopharma, Inc. (TBPH). It has been studied in Phase 1 clinical trials in healthy subjects, including healthy adults and elderly subjects. The drug is not approved and remains in clinical development.

What is TD-1439 used for?

TD-1439 has been studied in healthy volunteers, including healthy adults and elderly subjects, in early-stage clinical trials. Its intended therapeutic use has not been established, as it is still in Phase 1 development.

Who makes TD-1439?

TD-1439 is being developed by Theravance Biopharma, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol TBPH. The company has conducted Phase 1 studies of this investigational small molecule in the United States.

What phase is TD-1439 in?

TD-1439 is in Phase 1 clinical development. Two Phase 1 trials have been completed, including a single ascending dose study and a multiple ascending dose study in healthy subjects. The drug is investigational and has not been approved.

What clinical trials is TD-1439 in?

TD-1439 has been studied in two completed Phase 1 trials. NCT02903095 was a single ascending dose study in healthy subjects with 66 participants. NCT02954263 was a multiple ascending dose study in healthy adult and elderly subjects with 40 participants. Both were conducted in the United States.

Is TD-1439 the same as other drugs?

TD-1439 is the sole name provided for this investigational drug. No alternative names have been identified in the available clinical trial information.