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TR-701 FA with Tyramine

Phase 1

Healthy Volunteers | Small molecule | Other |Merck & Company, Inc.|Last Updated: May 3, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

TR-701 FA with Tyramine · 1 trial · 1 indication

Phase 1 1
NCT01539473A Phase 1 TR-701 FA Study of Blood Pressure Response Post Tyramine ChallengeHealthy Volunteers
COMPLETED30 Analytics
PHASE1COMPLETED
A Phase 1 TR-701 FA Study of Blood Pressure Response Post Tyramine Challenge
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Study Endpoints

Primary Endpoints

Systolic Blood Pressure
14 days

To assess tyramine dose required to cause increase of 30 mmHg in systolic blood pressure

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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP

Treatment Arms

ArmTypeDescription
TR-701 FA with TyramineEXPERIMENTALTR-701 FA 200 oral with Tyramine
Placebo-controlled with TyraminePLACEBO_COMPARATORPlacebo-controlled with Tyramine

Interventions

NameTypeDescription
TR-701 FA with TyramineDRUGTR-701 FA 200 mg oral and Tyramine
Placebo-controlled withTyramineDRUGPlacebo-controlled and Tyramine
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male or female subjects between 18 to 45 years of age, inclusive * Body mass index between 19 kg/m2 and 31 kg/m2, inclusive * Healthy subjects with no clinically significant abnormalities identified by a detailed medical history, Exclusion Criteria: * Systolic blood pressure...

Countries:United States
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Frequently asked questions about TR-701 FA with Tyramine

What is TR-701 FA used for?

TR-701 FA is an investigational small molecule being studied for bacterial infections, including skin and subcutaneous tissue bacterial infections such as major cutaneous abscess, cellulitis, and erysipelas. It has also been evaluated in healthy volunteers and in subjects with hepatic impairment.

Who is developing TR-701 FA?

TR-701 FA is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. The company has sponsored clinical trials of the drug in the United States.

What phase is TR-701 FA in?

TR-701 FA is in Phase 1 clinical development. It has completed Phase 1 trials, and one Phase 2 trial has also been completed. The drug remains investigational and is not yet approved for any use.

What clinical trials is TR-701 FA in?

TR-701 FA has completed several clinical trials, including NCT00983255, a Phase 1 ascending dose pharmacokinetic and absolute bioavailability study in bacterial infections; NCT01461460, a thorough QT study in healthy subjects; NCT01496677, a pharmacokinetics, safety, and tolerability study in elderly subjects; and NCT01519778, a Phase 2 safety and exploratory skin lesion measurement study.

Is TR-701 FA the same as TR-701 free acid?

Yes, TR-701 FA stands for TR-701 free acid. Clinical trial titles refer to TR-701 free acid (FA), and the drug is identified by the same name across studies. It is an investigational small molecule being studied for bacterial infections.