Role of Endothelin-A (ETA) and Endothelin-B (ETB) Receptors in the Vasodilatory Response to Endothelin-3 (ET-3)
NCT ID: NCT01100736
Last Updated: 2015-07-21
Study Results
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Basic Information
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COMPLETED
EARLY_PHASE1
10 participants
INTERVENTIONAL
2009-01-31
2010-01-31
Brief Summary
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We aim to investigate the endothelial ETB-mediated vascular responses between bosentan and sitaxsentan by using a ETB selective agonist (ET-3). We hypothesise that at clinically relevant doses:
* Bosentan will show evidence of ETB receptor blockade compared to sitaxsentan and placebo.
* These effects will be confirmed by 2 functional markers of ETB receptor antagonism: plasma ET-1 (a very sensitive, but not necessarily clinically relevant marker), and the forearm vasodilator response to ET-3.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
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Bosentan
Bosentan 125mg twice daily will be taken for 7 days, before ET-1 plasma sample taken. ET-3 infusion (5mins) and associated forearm blood flow study (60 mins) will also occur after 7 days of bosentan therapy
Endothelin-3
5 minute local intra-arterial infusion of endothelin-3 at a rate of rate of 60 pmol/min, during forearm blood flow studies
Bosentan
Bosentan 125mg tablets, orally, twice daily for 7 days
Sitaxsentan
Sitaxsentan 100mg once daily + placebo tablet will be taken for 7 days, before ET-1 plasma sample taken. ET-3 infusion (5mins) and associated forearm blood flow study (60 mins) will also occur after 7 days of sitaxsentan therapy
Sitaxsentan
Sitaxsentan 100mg tablets, orally, once daily for 7 days
Placebo
Placebo tablets taken twice daily, orally, for 7 days (placebo arm) or once daily for 7 days (sitaxsentan arm)
Endothelin-3
5 minute local intra-arterial infusion of endothelin-3 at a rate of rate of 60 pmol/min, during forearm blood flow studies
Placebo
Placebo tablet twice daily will be taken for 7 days, before ET-1 plasma sample taken. ET-3 infusion (5mins) and associated forearm blood flow study (60 mins) will also occur after 7 days of placebo therapy
Placebo
Placebo tablets taken twice daily, orally, for 7 days (placebo arm) or once daily for 7 days (sitaxsentan arm)
Endothelin-3
5 minute local intra-arterial infusion of endothelin-3 at a rate of rate of 60 pmol/min, during forearm blood flow studies
Interventions
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Sitaxsentan
Sitaxsentan 100mg tablets, orally, once daily for 7 days
Placebo
Placebo tablets taken twice daily, orally, for 7 days (placebo arm) or once daily for 7 days (sitaxsentan arm)
Endothelin-3
5 minute local intra-arterial infusion of endothelin-3 at a rate of rate of 60 pmol/min, during forearm blood flow studies
Bosentan
Bosentan 125mg tablets, orally, twice daily for 7 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18-70 years
* BMI 18-35 kg/m2
Exclusion Criteria
* Have donated blood within the last 4 weeks
* Have a history of past or present drug or alcohol abuse
* Have participated in another clinical trial within 1 month
* Are considered to be at a high risk of HIV or Hepatitis B
* Are taking routine medicines
* Are women taking hormone replacement therapy
* Have significant medical or psychiatric illness
18 Years
70 Years
ALL
Yes
Sponsors
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Encysive Pharmaceuticals
INDUSTRY
University of Edinburgh
OTHER
Responsible Party
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University of Edinburgh
Locations
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Clinical Research Centre, Western General Hospital
Edinburgh, Scotland, United Kingdom
Countries
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Other Identifiers
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08/S1102/1
Identifier Type: -
Identifier Source: secondary_id
2008/W/CRC/01
Identifier Type: -
Identifier Source: org_study_id
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