Icosabutate - A Phase I, Single Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Subjects
NCT ID: NCT02364635
Last Updated: 2015-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
32 participants
INTERVENTIONAL
2015-02-28
2015-08-31
Brief Summary
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Objective:
* To assess the safety and tolerability of single ascending oral doses of icosabutate in healthy subjects
* To evaluate the pharmacokinetic (PK) parameters of icosabutate in healthy subjects
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DOUBLE
Study Groups
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Icosabutate dose 1
Dose 1
icosabutate
Single dose at each dose levet
Icosabutate dose 2
Dose 2
icosabutate
Single dose at each dose levet
Icosabutate dose 3
Dose 3
icosabutate
Single dose at each dose levet
Placebo
Placebo (medium chain triglycerides)
icosabutate
Single dose at each dose levet
Icosabutate dose 4
Dose 4
icosabutate
Single dose at each dose levet
Interventions
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icosabutate
Single dose at each dose levet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* any ethnic origin
* Age 18-55 years
* BMI 18.0 - 33.0 kg/m2
* generally in good health
* signed informed consent
Exclusion Criteria
* recent blood donation
* recent blood received
* high consumption of alcohol
* high consumption of tobacco
* subjects who have engaged in heavy exercise last two weeks
* prescribed systemic or topical medication taken recently, or supplements/remedies interfering with study procedures or safety
* other medication know to alter drug absorption or elimination
* abnormal heart rate or blood pressure or 12-lead ECG
* significant history of drug allergy, or hypersensitivity to treatment ingredients
* ocular disorder requiring topical ocular therapy, or recent allergic eye disease
* other significant medical history or physical findings
18 Years
55 Years
ALL
Yes
Sponsors
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Pronova BioPharma
INDUSTRY
Responsible Party
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Principal Investigators
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Ashley Brooks, MD
Role: PRINCIPAL_INVESTIGATOR
Covance
Locations
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Covance Clinical Research Unit (CRU) Ltd.
Leeds, , United Kingdom
Countries
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Other Identifiers
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CTN401614104
Identifier Type: -
Identifier Source: org_study_id
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