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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00711126 |
This study will involve the use of a new medicine called GW642444 being developed for the treatment of asthma and chronic obstructive pulmonary disease (COPD). The purpose of the study is to see how safe and how well tolerated the study drug is when it is given as a liquid by mouth or by injection into a vein. In addition the study will measure how much of the medicine gets into the bloodstream when it is given by mouth, by injection into a vein and inhaled, and how long the body takes to get rid of it.
Condition | Intervention | Phase |
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Healthy Volunteer |
Drug: GW642444 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
Official Title: | A Single-Centre, Open-Label, Sequential, Dose-Ascending Study to Examine Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single Intravenous, Inhaled and Oral Doses of GW642444 in Healthy Male Subjects |
Enrollment: | 9 |
Study Start Date: | October 2008 |
Study Completion Date: | January 2009 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm 1: Experimental
HVTs
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Drug: GW642444
2.5mcg IV
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Arm 3: Experimental
HVTs
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Drug: GW642444
10mcg IV
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Arm 4: Experimental
HVTs
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Drug: GW642444
100mcg inhaled
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Arm 6: Experimental
HVTs
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Drug: GW642444
500mcg oral
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Arm 5: Experimental
HVTs
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Drug: GW642444
20mcg IV
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Arm 2: Experimental
HVTs
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Drug: GW642444
5mcg IV
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | B2C106180 |
Study First Received: | July 3, 2008 |
Last Updated: | January 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00711126 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
GW642444, intravenous, oral, inhaled, |
pharmacokinetics, pharmacodynamics, safety, tolerability |
Healthy |