Recent Updates
Recently added Catalysts

Lersivirine Immediate-Release

Phase 1

Healthy Volunteer | Small molecule | Other |Pfizer, Inc.|Last Updated: Sep 19, 2012

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

Lersivirine Immediate-Release · 1 trial · 1 indication

Phase 1 1
NCT01603485Study to Estimate the Pharmacokinetics, Bioavailability and Effect of Food on Single Dose Modified-release Lersivirine 500 mg in Healthy SubjectsHealthy Volunteer
COMPLETED16 Analytics
PHASE1COMPLETED
Study to Estimate the Pharmacokinetics, Bioavailability and Effect of Food on Single Dose Modified-release Lersivirine 500 mg in Healthy Subjects
Healthy Volunteer
NCT0160348516
Unlock trial analytics

Study Endpoints

Primary Endpoints

Lersivirine Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]
T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose
Lersivirine Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose
Lersivirine Maximum Observed Plasma Concentration (Cmax)
T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose

Secondary Endpoints

Lersivirine Plasma Decay Half-Life (t1/2)
T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose
Lersivirine Time to Reach Maximum Observed Plasma Concentration (Tmax)
T = 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36 and 48 hours post dose
Lersivirine Observed Plasma Concentration at time 24hr (C24)
T = 24 hours post dose
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
LersivirineEXPERIMENTAL -

Interventions

NameTypeDescription
Lersivirine Immediate-Release (fasted)DRUGSingle 500 mg dose of Lersivirine Immediate-Release Tablets (2 x 250 mg)
Lersivirine Modified-Release #1 (fasted)DRUGSingle 500 mg dose of Lersivirine Modified-Release Tablet #1
Lersivirine Modified-Release #2 (fasted)DRUGSingle 500 mg dose of Lersivirine Modified-Release Tablet #2
Lersivirine Modified-Release #3 (fasted)DRUGSingle 500 mg dose of Lersivirine Modified-Release Tablet #3
Lersivirine Modified-Release (fed)DRUGSingle 500 mg dose of Lersivirine Modified-Release Tablet dosed with food.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). * Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Exclusion Criteria: * History of regular alcohol consump...

Countries:Belgium
Unlock Eligibility Criteria

Frequently asked questions about Lersivirine Immediate-Release

What is Lersivirine Immediate-Release?

Lersivirine Immediate-Release is an investigational small molecule being developed by Pfizer, Inc. It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers to evaluate its pharmacokinetics, bioavailability, and the effect of food on a single dose.

What is Lersivirine Immediate-Release used for?

Lersivirine Immediate-Release is being studied in healthy volunteers. It is an investigational drug in Phase 1 clinical development. The completed trial focused on estimating the pharmacokinetics, bioavailability, and effect of food on a single dose of the drug.

Who makes Lersivirine Immediate-Release?

Lersivirine Immediate-Release is being developed by Pfizer, Inc., a company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical development.

What phase is Lersivirine Immediate-Release in?

Lersivirine Immediate-Release is in Phase 1 clinical development. It is an investigational drug 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 Lersivirine Immediate-Release in?

Lersivirine Immediate-Release has one completed clinical trial, NCT01603485, titled 'Study to Estimate the Pharmacokinetics, Bioavailability and Effect of Food on Single Dose Modified-release Lersivirine 500 mg in Healthy Subjects.' This Phase 1 study enrolled 16 healthy volunteers in Belgium.

Is Lersivirine Immediate-Release the same as Lersivirine?

Lersivirine Immediate-Release is a formulation of the drug lersivirine. The completed clinical trial NCT01603485 studied a modified-release formulation of lersivirine 500 mg, while the immediate-release version is also under development by Pfizer, Inc.