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PF-00232798

Phase 2

HIV | Small molecule | Infectious Disease |Pfizer, Inc.|Last Updated: Oct 30, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment43

FDA Designations

No designations recorded

Clinical trial landscape

PF-00232798 · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT00495677A Phase 2 Study Of PF-00232798 In HIV Positive PatientsHIV
COMPLETED43 Analytics
PHASE2COMPLETED
A Phase 2 Study Of PF-00232798 In HIV Positive Patients
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Study Endpoints

Primary Endpoints

Change From Baseline in Log 10-transformed Human Immunodeficiency Virus (HIV) Viral Load at Day 11
Baseline, Day 11

Viral load was determined using the Roche COBAS Taqman HIV-1 assay with a lower limit of detection of 40 copies per milliliter (copies/mL). Samples with an initial reading of less than 1,000,000 copies/mL were diluted into range and re-assayed.

QTc, using Fridericia's correction method (QTcF) at each time point of PF-00232798 and placebo on Day 7.
7 days

Secondary Endpoints

Number of Participants With Time to Rebound of Human Immunodeficiency Virus (HIV) Viral Load
Day 1 up to Day 25
Maximum Observed Plasma Concentration (Cmax)
0 hour (pre-dose) on Day 1 to 9; 0 hour (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10; Day 12, 13, 15 morning
Time to Reach Maximum Observed Plasma Concentration (Tmax)
0 hour (pre-dose) on Day 1 to 9; 0 hour (pre-dose), 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Day 10; Day 12, 13, 15 morning
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PF-00232798 40 mgACTIVE_COMPARATOR -
PF-00232798 300 mgACTIVE_COMPARATOR -
PF-00232798 400 mgACTIVE_COMPARATOR -
PF-00232798 5 mgACTIVE_COMPARATOR -
PF-00232798 20 mgACTIVE_COMPARATOR -
PF-00232798 150 mgACTIVE_COMPARATOR -
PF-00232798 supratherapeutic doseEXPERIMENTALPF-00232798 supratherapeutic dose
PF-00232798 therapeutic doseEXPERIMENTALPF-00232798 therapeutic dose
Placebo for PF-00232798PLACEBO_COMPARATORPlacebo for PF-00232798
MoxifloxacinACTIVE_COMPARATORMoxifloxacin

Interventions

NameTypeDescription
PF-00232798DRUGSolution, 20 mg. once daily, 10 days
PlaceboDRUGOral solution once daily x 7 days
MoxifloxacinDRUG400 mg tablet single dose
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Asymptomatic HIV-1 infected male patients between the ages of 18 and 55 years inclusive. * Patients with CCR5 tropic virus as determined by the Monogram PhenoSense Entry assay. Exclusion Criteria: * Patients who have received any experimental drug within the past four months...

Countries:GermanySingapore
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Frequently asked questions about PF-00232798

What is PF-00232798 used for?

PF-00232798 is an investigational small molecule being studied for the treatment of HIV. It is being developed by Pfizer, Inc. (PFE) for infectious disease. The drug has been evaluated in a Phase 2 clinical trial in HIV positive patients, but it is not approved and remains in clinical development.

Who makes PF-00232798?

PF-00232798 is being developed by Pfizer, Inc., which trades under the ticker symbol PFE. The company has conducted clinical trials of the drug in HIV positive patients and in healthy subjects. Pfizer is the sole developer of this investigational small molecule.

What phase is PF-00232798 in?

PF-00232798 is in Phase 2 clinical development. It has completed a Phase 2 study in HIV positive patients and a Phase 1 study in healthy subjects. The drug is investigational and has not been approved by regulatory authorities. No active trials are currently listed for this asset.

What clinical trials is PF-00232798 in?

PF-00232798 has been studied in two completed trials. NCT00495677 was a Phase 2 study in 43 HIV positive male patients in Germany. NCT01140425 was a Phase 1 study in 44 healthy subjects in Singapore to evaluate the effect of multiple oral doses on QT intervals. Both trials are completed.

Is PF-00232798 the same as any other drug?

No alternative names for PF-00232798 have been disclosed. The drug is identified solely by its development code PF-00232798 in clinical trial records. It is an investigational small molecule being studied for HIV and has no known brand name or other aliases.