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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00711386 |
To determine safety, tolerability and Pharmacokinetics of GSK706769
Condition | Intervention | Phase |
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Healthy Subjects |
Drug: GSK706769 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Single Group Assignment, Safety Study |
Official Title: | A Double-Blind, Randomized, Placebo-Controlled, Repeat Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK706769 in Healthy Male and Female Subjects |
Enrollment: | 40 |
Study Start Date: | May 2008 |
Study Completion Date: | September 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Repeat Dose: Placebo Comparator
Escalating doses
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Drug: GSK706769
GSK706769 or placebo
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Ages Eligible for Study: | 18 Years to 50 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:
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation. This includes subjects with a history of known or suspected sulfa related hypersensitivity.
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | CRR111382 |
Study First Received: | July 3, 2008 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00711386 History of Changes |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
GSK706769, CCR5 Healthy volunteers |
Healthy |