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GSK364735 and

Phase 1

HIV Infection | Small molecule | Infectious Disease |GSK plc|Last Updated: Jun 4, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment56

FDA Designations

No designations recorded

Clinical trial landscape

GSK364735 and · 1 trial · 2 indications

Phase 1 1
NCT00386347A Study To Evaluate Formulations And Food Effect On GSK364735 In Healthy Subjects.HIV Infection
COMPLETED56 Analytics
PHASE1COMPLETED
A Study To Evaluate Formulations And Food Effect On GSK364735 In Healthy Subjects.
HIV InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

Part 1: PK parameters Day 1: AUC(0-t), AUC(0-t), Cmax, and C12 and C24 Part 2: PK parameters on Day 6: AUC(0-t), Ct, and Cmax

Secondary Endpoints

Part 1 and 2 safety measures: AE, Clinical labs, con meds, ECGs, and Vital signs Part 1: PK parameters Day 1: tmax, t1/2, tlag and CL/F Part 2: PK parameters Day 1&6: AUC 0-t, AUC 0-infinity, AUC 0-12, Cmax, C12 or C24, tmax, t1/2, CL/F, and tlag.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Interventions

NameTypeDescription
GSK364735 oral solution and oral tabletsDRUG -
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion criteria: * The subject is healthy with no clinically significant problems identified by the physician. * Females of non-childbearing potential and males surgically sterile or agrees to birth control. * Body mass Index (BMI) of 19-29.9 (kg/m2). Exclusion criteria: * As a result of the p...

Countries:United States
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Frequently asked questions about GSK364735 and

What is GSK364735 used for?

GSK364735 is an investigational small molecule being developed for the treatment of HIV infection, including HIV-1 infection. It is being studied in adults with HIV who have not previously been treated with integrase inhibitors. The drug is currently in clinical development and is not approved by the FDA.

What does GSK364735 target?

GSK364735 is being studied as a monotherapy in integrase-naive HIV-1 infected adults, indicating it targets the HIV integrase enzyme. By inhibiting integrase, the drug aims to block viral DNA integration into host cells, thereby reducing viral replication. This mechanism is being evaluated in clinical trials.

Who makes GSK364735?

GSK364735 is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating HIV infection.

What phase is GSK364735 in?

GSK364735 is in Phase 2 clinical development. It has completed a Phase 1 study in healthy subjects and a Phase 2 study in HIV-1 infected adults. The drug is investigational and has not received FDA approval. Its development status is based on completed trials.

What clinical trials is GSK364735 in?

GSK364735 has been studied in two completed clinical trials. NCT00386347 was a Phase 1 study evaluating formulations and food effects in healthy subjects. NCT00398125 was a Phase 2 monotherapy versus placebo study over 10 days in integrase-naive HIV-1 infected adults. Both trials were conducted in the United States.

Is GSK364735 the same as another drug?

GSK364735 is not known to have alternative names. It is identified by its compound number in clinical trials and is being developed solely by GSK plc. No other names or aliases have been associated with this drug in the available clinical trial information.