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darunavir/ritonavir

Phase 1

Healthy Subjects | Small molecule | Infectious Disease |GSK plc|Last Updated: Nov 3, 2010

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

darunavir/ritonavir · 1 trial · 2 indications

Phase 1 1
NCT00920088Drug Interaction Study of Darunavir/Ritonavir and Lopinavir/Ritonavir on GSK2248761 PK and CYP450 Probe DrugsHealthy Subjects
COMPLETED24 Analytics
PHASE1COMPLETED
Drug Interaction Study of Darunavir/Ritonavir and Lopinavir/Ritonavir on GSK2248761 PK and CYP450 Probe Drugs
Healthy SubjectsUnlock trial analytics

Study Endpoints

Primary Endpoints

PK parameters
35 days

Secondary Endpoints

12-lead ECGs
35 days
clinical laboratory assessments
35 days
vital signs
35 days
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTALGSK2248761 with LPV/RTV arm and probes
Cohort 2EXPERIMENTALGSK2248761 with DRV/RTV

Interventions

NameTypeDescription
darunavir/ritonavirDRUGDRV/RTV 600/100mg
lopinavir/ritonavirDRUGLPV/RTV 400/100mg
MidazolamDRUGMidazolam 3mg
DextromethorphanDRUGDextromethorphan 30mg
FlurbiprofenDRUGFlurbiprofen 50mg
GSK2248761DRUGNNRTI under investigation
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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 and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. * Male or female between 18 and 50 years of age inclusive, at the time of signing the infor...

Countries:United States
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Frequently asked questions about darunavir/ritonavir

What is Darunavir used for?

Darunavir is a small molecule drug being studied in healthy subjects and healthy volunteers. It is being investigated in clinical trials for potential use in treating Human Immunodeficiency Virus (HIV) infection. The drug is currently in Phase 1 clinical development.

Who makes Darunavir?

Darunavir is being developed by GSK plc, a pharmaceutical company traded on the stock exchange under the ticker symbol GSK. The company is conducting clinical trials to evaluate the drug's safety and interactions in healthy volunteers.

What phase is Darunavir in?

Darunavir is in Phase 1 clinical development. It is an investigational drug that has not yet been approved by regulatory authorities. The drug is being studied in early-stage clinical trials to assess its safety, tolerability, and drug interactions.

What clinical trials is Darunavir in?

Darunavir has been studied in two completed Phase 1 clinical trials. NCT00867152 evaluated drug interactions with etravirine and either darunavir/ritonavir or lopinavir/ritonavir. NCT00920088 studied drug interactions of darunavir/ritonavir and lopinavir/ritonavir on GSK2248761 pharmacokinetics and CYP450 probe drugs.

Is Darunavir FDA approved?

Darunavir is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The drug has been studied in clinical trials involving healthy volunteers, but it has not received regulatory approval for any medical use.

What does Darunavir target?

Darunavir is a small molecule drug being studied for its potential effects in healthy subjects. The specific molecular target of Darunavir has not been disclosed in the available clinical trial information. The drug is being evaluated for its safety and drug interactions in early-stage trials.