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
2010-05-31
2011-03-31
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
TREATMENT
DOUBLE
Study Groups
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E1. CG400549 640mg
CG400549 640mg BID on Day 1-5 and QD on Day 6 in the fed-state
CG400549 640mg
multiple oral doses of 640 mg CG400549 (n=6) BID for 5 days (Days 1-5) and a final dose on Day 6 in the fed state
E2: CG400549 320mg
CG400549 320mg QD on Day 1-5 in the fed-state.
CG400549 320 mg
multiple oral doses of 320 mg CG400549 (n=6) QD for 5 days in the fed state
E3: CG400549 640mg
CG400549 640mg QD on Day 1-5 in the fed-state.
CG400549 640 mg
multiple oral doses of 640 mg CG400549 (n=6) QD for 5 days in the fed state
E4: CG400549 960mg
CG400549 960mg QD on Day 1-5 in the fed-state.
CG400549 960 mg
multiple oral doses of 960 mg CG400549 (n=6) QD for 5 days in the fed state
P1 Placebo
Placebo 640mg BID on Day 1-5 and QD on Day 6 in the fed-state
Placebo 640mg
multiple oral doses of 640 mg placebo (n=2) BID for 5 days (Days 1-5) and a final dose on Day 6 in the fed state
P2: Placebo 320mg
Placebo 320mg QD on Day 1-5 in the fed-state
Placebo 320mg
multiple oral doses of 320 mg placebo (n=2) QD for 5 days in the fed state
P3 Placebo 640mg
Placebo 640mg QD on Day 1-5 in the fed-state.
placebo 960 mg
multiple oral doses of 960 mg placebo (n=2) QD for 5 days in the fed state
P4: Placebo 960mg
Placebo 960mg QD on Day 1-5 in the fed-state.
Placebo 640mg
multiple oral doses of 640 mg placebo (n=2) QD for 5 days in the fed state
Interventions
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CG400549 640mg
multiple oral doses of 640 mg CG400549 (n=6) BID for 5 days (Days 1-5) and a final dose on Day 6 in the fed state
CG400549 320 mg
multiple oral doses of 320 mg CG400549 (n=6) QD for 5 days in the fed state
CG400549 640 mg
multiple oral doses of 640 mg CG400549 (n=6) QD for 5 days in the fed state
CG400549 960 mg
multiple oral doses of 960 mg CG400549 (n=6) QD for 5 days in the fed state
Placebo 640mg
multiple oral doses of 640 mg placebo (n=2) BID for 5 days (Days 1-5) and a final dose on Day 6 in the fed state
Placebo 320mg
multiple oral doses of 320 mg placebo (n=2) QD for 5 days in the fed state
placebo 960 mg
multiple oral doses of 960 mg placebo (n=2) QD for 5 days in the fed state
Placebo 640mg
multiple oral doses of 640 mg placebo (n=2) QD for 5 days in the fed state
Eligibility Criteria
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Inclusion Criteria
* Body Mass Index :19-30 kg/m2, inclusive
* Sex:male
* Other criteria:healthy; non-smoking or smoking ≤ 10 cigarettes/day
Exclusion Criteria
* History of bacterial or viral infection requiring treatment with antibiotics or antivirals within 1 month of study
* Presence or history of esophageal or gastroduodenal ulceration within 1 month before screening.
18 Years
55 Years
MALE
Yes
Sponsors
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CrystalGenomics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Seonggu Ro, PhD
Role: STUDY_CHAIR
CrystalGenomics, Inc.
Locations
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PRA International clinical center
Zuidlaren, , Netherlands
Countries
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Other Identifiers
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CG400549-1-02
Identifier Type: -
Identifier Source: org_study_id
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