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TR-701 di- salt

Phase 1

Healthy | 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

RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

TR-701 di- salt · 1 trial · 1 indication

Phase 1 1
NCT00876655Exploratory Pharmacokinetic and Bioavailability Study of 2 Capsule Formulations of Torezolid PhosphateHealthy
COMPLETED12 Analytics
PHASE1COMPLETED
Exploratory Pharmacokinetic and Bioavailability Study of 2 Capsule Formulations of Torezolid Phosphate
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Study Endpoints

Primary Endpoints

To evaluate the pharmacokinetics and relative bioavailability of TR-701 free acid phosphate powder in capsule formulation compared to di-sodium phosphate salt formulated capsule after single doses in normal healthy adult subjects
4 days

Secondary Endpoints

To determine the safety and tolerability of 2 different TR-701 oral formulations (free acid phosphate powder in capsule and di-sodium phosphate salt formulated capsule) after single doses in normal healthy adult
4 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
free acidEXPERIMENTALTR-701 free acid phosphate powder in capsule formulation (equivalent to 150 mg TR-700)
di-sodium phosphate saltEXPERIMENTALOne 200 mg capsule of TR-701 di-sodium phosphate salt (equivalent to 150 mg TR-700)

Interventions

NameTypeDescription
TR-701 di-sodium phosphate saltDRUGOne 200 mg capsule of TR-701 di-sodium phosphate salt (equivalent to 150 mg TR-700)
TR-701 free acid phosphateDRUGOne 182 mg capsule of TR-701 free acid phosphate (equivalent to 150 mg TR-700)
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, and vital signs; * Females will be non-pregnant, non-lactating, and either postmenopausal for at least 1 year, surgically sterile for at least 90 days, or ...

Countries:United States
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Frequently asked questions about TR-701 di- salt

What is TR-701 di-salt?

TR-701 di-salt is an investigational small molecule being developed by Merck & Company, Inc. (MRK). It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers, with one completed trial involving 12 participants.

What is TR-701 di-salt used for?

TR-701 di-salt is being studied for use in healthy volunteers. The completed Phase 1 trial was an exploratory pharmacokinetic and bioavailability study of two capsule formulations of torezolid phosphate. The drug is still in early clinical development and is not approved for any medical condition.

Who makes TR-701 di-salt?

TR-701 di-salt is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's pharmacokinetics and bioavailability in healthy subjects.

What phase is TR-701 di-salt in?

TR-701 di-salt is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and no active trials are currently listed.

What clinical trials is TR-701 di-salt in?

TR-701 di-salt has one completed clinical trial, NCT00876655, titled "Exploratory Pharmacokinetic and Bioavailability Study of 2 Capsule Formulations of Torezolid Phosphate." This Phase 1 study enrolled 12 healthy volunteers in the United States and was controlled and biomarker-selected.