Absolute Bioavailability of Lu AE58054 in Healthy Subjects
NCT ID: NCT02019394
Last Updated: 2014-03-21
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
10 participants
INTERVENTIONAL
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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Lu AE58054
Lu AE58054
Oral dosing: 90 mg Lu AE58054 as a single dose once and after a 3 days washout period, once daily for 7 days.
Intravenous dosing: 90 μg/not more than (NMT) 1000 nCi/37 kBq 14C-Lu AE58054 for intravenous infusion once on Day 10.
Interventions
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Lu AE58054
Oral dosing: 90 mg Lu AE58054 as a single dose once and after a 3 days washout period, once daily for 7 days.
Intravenous dosing: 90 μg/not more than (NMT) 1000 nCi/37 kBq 14C-Lu AE58054 for intravenous infusion once on Day 10.
Eligibility Criteria
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Inclusion Criteria
* The subjects CYP2D6 genotype must be determined before inclusion into the study.
* Women must not be pregnant or lactating.
Exclusion Criteria
21 Years
55 Years
ALL
Yes
Sponsors
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H. Lundbeck A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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GB803
Nottingham, , United Kingdom
Countries
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Other Identifiers
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2012-005646-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
14915A
Identifier Type: -
Identifier Source: org_study_id
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