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Sponsored by: |
Gilead Sciences |
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Information provided by: | Gilead Sciences |
ClinicalTrials.gov Identifier: | NCT00800579 |
The purpose of this study is to evaluate the safety and tolerability of escalating doses of GS-9411 in healthy male volunteers. GS-9411 is a sodium channel inhibitor, that may restore airway hydration and mucociliary clearance in the lung.
Condition | Intervention | Phase |
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Cystic Fibrosis |
Drug: GS-9411 Drug: Placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety Study |
Official Title: | A Randomised, Double-Blind, Placebo-Controlled Trial to Assess the Safety, Tolerability and Pharmacokinetics of GS-9411 in Healthy Male Volunteers |
Estimated Enrollment: | 12 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
GS-9411 0.6 mg
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Drug: GS-9411
Inhaled GS-9411 dissolved in sterile saline
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2: Experimental
GS-9411 1.2 mg
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Drug: GS-9411
Inhaled GS-9411 dissolved in sterile saline
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3: Experimental
GS-9411 2.4 mg
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Drug: GS-9411
Inhaled GS-9411 dissolved in sterile saline
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4: Placebo Comparator
Inhaled volume-matched sterile saline placebo
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Drug: Placebo
Inhaled volume-matched placebo in sterile saline
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GS-9411 is being evaluated as a potential therapy to improve airway hydration and mucociliary clearance in patients with cystic fibrosis. This study is evaluating the safety and tolerability of 3 dose levels of GS-9411 as an inhaled product, compared to a matched placebo.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jeffery Wong | 613-9076-8900 | j.wong@nucleusnetwork.com.au |
Contact: Zafirah Khan | 613-9076-8936 | z.khan@nucleusnetwork.com.au |
Australia, Victoria | |
Nucleus Network Ltd. | Recruiting |
Melbourne, Victoria, Australia, 3004 |
Principal Investigator: | Peter Hodsman, MD | Nucleus Network Ltd |
Responsible Party: | Gilead Sciences, Inc. ( Thomas O'Riordan, MD ) |
Study ID Numbers: | GS-US-221-0101 |
Study First Received: | November 21, 2008 |
Last Updated: | December 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00800579 |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
cystic fibrosis CF mucociliary clearance amiloride |
ENaC ENaC Inhibitor airway hydration epithelial sodium channel inhibitor |
Digestive System Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Cystic Fibrosis Fibrosis Lung Diseases |
Amiloride Infant, Newborn, Diseases Pancreatic Diseases Healthy Cystic fibrosis |
Pathologic Processes |