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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00726336 |
A study in healthy volunteers to determine whether there is a drug interaction between GSK1349572 and tenofovir
Condition | Intervention | Phase |
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Healthy Subjects |
Drug: GSK1349572 and tenofovir |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Pharmacokinetics Study |
Official Title: | A Phase I, Open Label, Single Sequence,Drug Interaction Study Evaluating Plasma GSK1349572 and Tenofovir Pharmacokinetics in Healthy Adult Subjects (ING111604) |
Estimated Enrollment: | 16 |
Study Start Date: | August 2008 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
A female subject is eligible to participate if she is of non-childbearing potential (i.e., physiologically incapable of becoming pregnant) including any female who:
Exclusion Criteria:
History of regular alcohol consumption within 6 months of the study defined as:
· An average weekly intake of >14 drinks/week for men or >7 drinks/week for women. 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.
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 111604 |
Study First Received: | July 29, 2008 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00726336 |
Health Authority: | United States: Food and Drug Administration |
healthy volunteer pharmacokinetics GSK1349572 integrase |
Tenofovir Healthy Tenofovir disoproxil |
Anti-Infective Agents Anti-HIV Agents Anti-Retroviral Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Enzyme Inhibitors Antiviral Agents Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Reverse Transcriptase Inhibitors |