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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00723775 |
To compare plasma GSK706769 PK following repeat administration of GSK706769 QD with and without KALETRA (LPV 400 mg/RTV 100mg) q12h
Condition | Intervention | Phase |
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Healthy Subjects |
Drug: GSK706769 & KALETRA |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study |
Official Title: | Phase I, Open Label Drug-Drug Interaction Study in Healthy Volunteers to Evaluate the Effect of KALETRA (Lopinavir-Ritonavir) on GSK706769 Pharmacokinetics and to Evaluate the Pharmacokinetics of a New Oral Formulation of GSK706769 |
Enrollment: | 28 |
Study Start Date: | July 2008 |
Study Completion Date: | November 2008 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Part 1
GSK706769 new vs. current formulation; GSK706769 alone vs. GSK706769 plus Kaletra
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Drug: GSK706769 & KALETRA
GSK706769 alone and GSK706769 + Kaletra
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Part 2
GSK706769 alone for 10 days; GSK706769 + Kaletra for 14 days
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Drug: GSK706769 & KALETRA
GSK706769 alone and GSK706769 + Kaletra
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Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
An average weekly intake of >14 drinks/week for men or >7 drinks/week for women.
Note: One drink is equivalent to (12 g alcohol) = 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of 80 proof distilled spirits.
Note: "Study" or "investigational" drugs include GSK706769 or Kaletra
Note: this does not include plasma donation.
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | CRR110744 |
Study First Received: | July 28, 2008 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00723775 History of Changes |
Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
GSK706769 healthy volunteers HIV KALETRA |
HIV Protease Inhibitors Anti-HIV Agents Anti-Retroviral Agents Lopinavir Ritonavir |
HIV Infections Acquired Immunodeficiency Syndrome Healthy Antiviral Agents Protease Inhibitors |
Anti-Infective Agents HIV Protease Inhibitors Anti-HIV Agents Anti-Retroviral Agents Molecular Mechanisms of Pharmacological Action Lopinavir |
Therapeutic Uses Enzyme Inhibitors Antiviral Agents Pharmacologic Actions Protease Inhibitors |