Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of PAT-1251 in Healthy Adult Subjects
NCT ID: NCT02852551
Last Updated: 2016-11-30
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
78 participants
INTERVENTIONAL
2016-07-31
2016-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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PAT-1251 Single Dose
Oral solution of PAT-1251, 150 - 4000 mg administered once
PAT-1251
Placebo Single Dose
Matching placebo solution administered once
Placebo
PAT-1251 Multiple Dose
Oral tablet(s) of PAT-1251 up to 2000 mg administered daily for 7 days
PAT-1251
Placebo Multiple Dose
Matching placebo tablets administered daily for 7 days
Placebo
Interventions
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PAT-1251
Placebo
Eligibility Criteria
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Inclusion Criteria
* body weight of 50 to 100 kg, inclusive
* subjects must be in good health
Exclusion Criteria
* female subjects of childbearing potential who do not agree to use 2 acceptable methods of contraception
* history of, any clinically significant major disorder
* clinically significant allergic condition
* significant history of alcoholism or drug/chemical abuse
* use of any tobacco or nicotine-containing products
* clinically significant abnormality in heart rate, blood pressure, temperature, respiration rate, electrocardiogram or clinical laboratory findings
* positive urine drugs of abuse screen or alcohol breath test
18 Years
55 Years
ALL
Yes
Sponsors
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PharmAkea, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Kevin Holme, Ph.D.
Role: STUDY_DIRECTOR
PharmAkea, Inc.
Locations
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Covance Clinical Research Unit Ltd.
Leeds, , United Kingdom
Countries
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Related Links
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Sponsor Website
Other Identifiers
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PAT-1251-CL-001
Identifier Type: -
Identifier Source: org_study_id