A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacology of ONO-4474 in Healthy Volunteers
NCT ID: NCT02454387
Last Updated: 2016-06-30
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
141 participants
INTERVENTIONAL
2015-05-31
2016-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Experimental: ONO-4474 Part A1
Single doses of ONO-4474 or placebo, randomized 3 active: 1 placebo
ONO-4474 Part A1
Healthy volunteers
Experimental: ONO-4474 Placebo Part A1
Single doses of ONO-4474 or placebo, randomized 3 active: 1 placebo
Placebo Part A1
Healthy volunteers
Experimental: ONO-4474 Part A2
Single doses (2 periods) of ONO-4474 or placebo, randomized 3 active: 1 placebo
ONO-4474 Part A2
Healthy volunteers
Experimental: ONO-4474 Placebo Part A2
Single doses (2 periods) of ONO-4474 or placebo, randomized 3 active: 1 placebo
Placebo Part A2
Healthy volunteers
Experimental: ONO-4474 Part B
Multiple ascending doses of ONO-4474 or placebo, randomized 3 active: 1 placebo
ONO-4474 Part B
Healthy volunteers
Experimental: ONO-4474 Placebo Part B
Multiple ascending doses of ONO-4474 or placebo, randomized 3 active: 1 placebo
Placebo Part B
Healthy volunteers
Experimental: ONO-4474 Part C
NGF hyperalgesia and single or multiple doses of ONO-4474, randomized 1 active: 1 placebo in cross over design
ONO-4474 Part C
Healthy volunteers
Experimental: ONO-4474 Placebo Part C
NGF hyperalgesia and single or multiple doses of ONO-4474, randomized 1 active: 1 placebo in cross over design
Placebo Part C
Healthy volunteers
Experimental: ONO-4474 Part D
Single doses of ONO-4474 or placebo, randomized 3 active: 1 placebo
ONO-4474 Part D
Healthy volunteers
Experimental: ONO-4474 Placebo Part D
Single doses of ONO-4474 or placebo, randomized 3 active: 1 placebo
Placebo Part D
Healthy volunteers
Interventions
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ONO-4474 Part A1
Healthy volunteers
Placebo Part A1
Healthy volunteers
ONO-4474 Part A2
Healthy volunteers
Placebo Part A2
Healthy volunteers
ONO-4474 Part B
Healthy volunteers
Placebo Part B
Healthy volunteers
ONO-4474 Part C
Healthy volunteers
Placebo Part C
Healthy volunteers
ONO-4474 Part D
Healthy volunteers
Placebo Part D
Healthy volunteers
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subjects with a body mass index of 18.0-30.0 kg/m2 inclusive
Exclusion Criteria
2. Current smokers or those that have smoked or used nicotine products within 6 months of the Screening visit
18 Years
65 Years
ALL
Yes
Sponsors
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Ono Pharmaceutical Co. Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Drug Development Division
Role: STUDY_DIRECTOR
Ono Pharmaceutical Co. Ltd
Locations
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Aalborg Clinical Site
Aalborg, , Denmark
Nottingham Clinical SIte
Nottingham, , United Kingdom
Countries
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Other Identifiers
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ONO-4474-01
Identifier Type: -
Identifier Source: org_study_id
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