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BLI-489

Phase 1

Undisclosed | Small molecule | Other |Pfizer, Inc.|Trials Updated: Sep 27, 2018

BLI-489 development status

Highest phase Phase 1
Registered trials 4 across 1 sponsor since Jan 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials4
Total Enrollment134

FDA Designations

No designations recorded

BLI-489 clinical trials

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?

BLI-489 is an investigational small molecule developed by Pfizer, Inc. (ticker PFE). It has been studied in Phase 1 clinical trials involving healthy adult volunteers, including a study of BLI-489 combined with piperacillin. No patient indication has been disclosed for the program.

Who makes BLI-489?

BLI-489 is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer sponsored the Phase 1 clinical program for the compound, including trials conducted in the United States and Japan.

What phase is BLI-489 in?

BLI-489 is in Phase 1 development. All four of its recorded clinical trials are Phase 1 studies, and all four are completed, with no active trials ongoing. It is an investigational agent and has not been approved by the FDA.

What clinical trials is BLI-489 in?

BLI-489 has been evaluated in four completed Phase 1 trials: NCT00909688, a multiple-dose tolerability study in healthy subjects; NCT00894439, a study of BLI-489 and piperacillin in healthy subjects; NCT00854009, a single-dose study in healthy Japanese male subjects; and NCT00820404, a single-dose study in healthy subjects.

How many patients have been enrolled in BLI-489 trials?

Across the four completed Phase 1 trials, 134 participants have been enrolled. The studies were randomized, double-blind, and placebo-controlled, and all enrolled healthy volunteers rather than patients with a disclosed disease indication.