Effect of Multiple Doses of Itraconazole on the Multiple Dose Pharmacokinetics of Lu AE58054 in Healthy Subjects
NCT ID: NCT02122692
Last Updated: 2014-06-19
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
20 participants
INTERVENTIONAL
2014-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lu AE58054 30 mg + itraconazole 200 mg
Lu AE58054 30 mg
Lu AE58054 encapsulated film-coated tablets, once daily, Day 1-5, orally
Lu AE58054 30 mg + itraconazole 200 mg
Lu AE58054 encapsulated film-coated tablets, once daily, Day 6-11, orally + itraconazole capsules, once daily, Day 6-11, orally
Itraconazole
Itraconazole capsules, once daily, Day 12-13, orally
Interventions
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Lu AE58054 30 mg
Lu AE58054 encapsulated film-coated tablets, once daily, Day 1-5, orally
Lu AE58054 30 mg + itraconazole 200 mg
Lu AE58054 encapsulated film-coated tablets, once daily, Day 6-11, orally + itraconazole capsules, once daily, Day 6-11, orally
Itraconazole
Itraconazole capsules, once daily, Day 12-13, orally
Eligibility Criteria
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Inclusion Criteria
* Men and women, aged 18 - 45 years.
* Body weight at least 50 kg and Body Mass index 19 - 28 kg/m2.
* Good general health ascertained by a detailed medical history, laboratory tests and physical examination.
* Non-childbearing potential or use of contraception (both sexes).
* Women must not be pregnant or lactating.
* Known CYP2D6 genotype (Extensive metaboliser (n=15) and poor metaboliser (n =5)) .
18 Years
45 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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FR801
Rennes, , France
Countries
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Other Identifiers
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2013-003597-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
15820A
Identifier Type: -
Identifier Source: org_study_id
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