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GSK706769 & KALETRA

Phase 1

Infection, Human Immunodeficiency Virus | Small molecule | Infectious Disease |GSK plc|Last Updated: Jul 21, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment17

FDA Designations

No designations recorded

Clinical trial landscape

GSK706769 & KALETRA · 1 trial · 1 indication

Phase 1 1
NCT00723775GSK706769/KALETRA Drug-drug Interaction StudyInfection, Human Immunodeficiency Virus
COMPLETED17 Analytics
PHASE1COMPLETED
GSK706769/KALETRA Drug-drug Interaction Study
Infection, Human Immunodeficiency VirusUnlock trial analytics

Study Endpoints

Primary Endpoints

GSK706769 PK
Part 1: 4 days; Part 2; 25 days

Secondary Endpoints

GSK706769 safety parameters, including adverse events, clinical laboratory, ECG, and vital signs assessments.
Part 1: 4 days; Part 2; 25 days
Plasma GSK706769 AUC(0-∞), AUC(0-t), and Cmax following a single dose of GSK706769 50mg and following combined administration of a single dose of GSK706769 50mg with a single dose of LPV 400mg/RTV 100mg.
Part 1: 4 days; Part 2; 25 days
Plasma metabolite GSK1996847 AUC(0-∞), AUC(0-t), and Cmax following a single dose of GSK706769 50mg and following combined administration of a single dose of GSK706769 50mg with a single dose of LPV 400mg/RTV 100mg.
Part 1: 4 days; Part 2; 25 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1OTHERGSK706769 new vs. current formulation; GSK706769 alone vs. GSK706769 plus Kaletra
Part 2OTHERGSK706769 alone for 10 days; GSK706769 + Kaletra for 14 days

Interventions

NameTypeDescription
GSK706769 & KALETRADRUGGSK706769 alone and GSK706769 + Kaletra
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy as determined by a responsible physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the populati...

Countries:United States
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Frequently asked questions about GSK706769 & KALETRA

What is GSK706769 used for?

GSK706769 is an investigational small molecule being studied for the treatment of Human Immunodeficiency Virus (HIV) infection. It is in Phase 1 clinical development and has been evaluated in a drug-drug interaction study in combination with KALETRA. The drug is not yet approved and remains in clinical trials.

Who makes GSK706769?

GSK706769 is being developed by GSK plc, a global biopharmaceutical company listed on the London Stock Exchange under the ticker GSK. The company is conducting clinical research on this investigational small molecule for the treatment of HIV infection.

What phase is GSK706769 in?

GSK706769 is in Phase 1 clinical development. It has completed one Phase 1 trial, a drug-drug interaction study with KALETRA, which enrolled 17 participants. The drug is investigational and has not received regulatory approval.

What clinical trials is GSK706769 in?

GSK706769 has been studied in one completed clinical trial, NCT00723775, titled "GSK706769/KALETRA Drug-drug Interaction Study." This Phase 1 trial enrolled 17 participants in the United States and evaluated the drug in healthy volunteers.

Is GSK706769 the same as KALETRA?

No, GSK706769 is not the same as KALETRA. GSK706769 is an investigational small molecule being developed by GSK plc, while KALETRA is a separate drug used in the clinical trial as a combination partner. The study NCT00723775 was designed to assess the drug-drug interaction between the two.