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BLI-489

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Sep 27, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment56

FDA Designations

No designations recorded

Clinical trial landscape

BLI-489 · 4 trials · 2 indications

Phase 1 4
NCT00909688Study to Evaluate Whether BLI-489 Can be Safely Tolerated by Healthy Subjects Given Multiple DosesHealthy
COMPLETED16 Analytics
NCT00894439Study Evaluating BLI-489 and Piperacillin in Healthy SubjectsHealthy Subjects
COMPLETED24 Analytics
NCT00854009Study Evaluating Single Doses of BLI-489 in Healthy Japanese Male SubjectsHealthy
COMPLETED40 Analytics
NCT00820404Study Evaluating Single Doses of BLI-489 in Healthy SubjectsHealthy Subjects
COMPLETED54 Analytics
PHASE1COMPLETED
Study to Evaluate Whether BLI-489 Can be Safely Tolerated by Healthy Subjects Given Multiple Doses
HealthyUnlock trial analytics
PHASE1COMPLETED
Study Evaluating BLI-489 and Piperacillin in Healthy Subjects
Healthy SubjectsUnlock trial analytics
PHASE1COMPLETED
Study Evaluating Single Doses of BLI-489 in Healthy Japanese Male Subjects
HealthyUnlock trial analytics
PHASE1COMPLETED
Study Evaluating Single Doses of BLI-489 in Healthy Subjects
Healthy SubjectsUnlock trial analytics

Study Endpoints

Primary Endpoints

Assess safety of drug given to healthy subjects by evaluating any reported adverse events (AEs), scheduled physical examinations, vital sign measurements, 12-lead ECGs, and clinical laboratory test results.
4 months
Pharmacokinetics as evaluated by drug concentrations in the blood and urine.
10 days
Safety as measured by the number of adverse events and serious adverse events. Tolerability will be assessed based upon the occurrence of dose limiting toxicities.
15 days

Secondary Endpoints

Safety as measured by the number of adverse events and serious adverse events.
10 weeks
Pharmacokinetics as evaluated by drug concentrations in the blood and urine.
4 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelSINGLE_GROUP
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTALBLI-489
2PLACEBO_COMPARATORplacebo

Interventions

NameTypeDescription
BLI-489DRUG -
placeboDRUG -
BLI-489/PiperacillinDRUG -
PiperacillinDRUG -
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Men or women of non-childbearing potential (WONCBP) aged 18 to 50 years inclusive at screening; * Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight ≥50 kg.; * Healthy as determined by the investigator on the basis of screening evaluations; * Calculated creat...

Countries:United StatesJapan
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Frequently asked questions about BLI-489

What is BLI-489 used for?

BLI-489 is an investigational small molecule being studied in healthy subjects, including healthy Japanese male subjects. It is being evaluated in Phase 1 clinical trials to assess its safety, tolerability, and pharmacokinetics, both alone and in combination with piperacillin. It is not approved for any disease indication.

Who makes BLI-489?

BLI-489 is being developed by Pfizer, Inc., which trades under the ticker symbol PFE on the New York Stock Exchange. The company is conducting Phase 1 clinical trials of this investigational small molecule in healthy volunteers.

What phase is BLI-489 in?

BLI-489 is in Phase 1 clinical development. All four clinical trials listed for the drug are Phase 1 studies and have been completed. The drug remains investigational and has not been approved by regulatory authorities.

What clinical trials is BLI-489 in?

BLI-489 has been studied in four completed Phase 1 trials: NCT00820404 and NCT00854009 evaluated single doses in healthy subjects and healthy Japanese male subjects, respectively; NCT00894439 evaluated BLI-489 with piperacillin; and NCT00909688 evaluated multiple doses. All trials are completed.

Is BLI-489 the same as piperacillin?

No, BLI-489 is not the same as piperacillin. BLI-489 is an investigational small molecule being studied alone and in combination with piperacillin in a Phase 1 clinical trial (NCT00894439) to evaluate the safety and tolerability of the combination in healthy subjects.