Study With Lu AF35700 in Healthy Men and Women in Fasting and Fed State
NCT ID: NCT03670082
Last Updated: 2019-11-01
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
2018-09-05
2019-01-13
Brief Summary
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Detailed Description
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For Group 1, period 1 only, a single intravenous micro-dose of Lu AF35700 will be given 4 hours after oral dosing.
All subjects will be confined to the clinic from one day prior to the first dosing until Day 6 (120 hours post dose) for each dosing period. Periods I and II will be separated by a period of 6 weeks.
Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Group 1: Fasting condition in Period I
Subjects will be in fasting condition in Period I and in a fed condition in Period II.
Lu AF35700
20 mg Lu AF35700 single oral dose
Lu AF35700 iv
100 μg \[14C\]-Lu AF35700 (4.7 μCi/174 kBq) single intravenous micro-dose
Group 2: Fed condition in Period I
Subjects will be in fed condition in Period I and in fasting condition in Period II.
Lu AF35700
20 mg Lu AF35700 single oral dose
Interventions
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Lu AF35700
20 mg Lu AF35700 single oral dose
Lu AF35700 iv
100 μg \[14C\]-Lu AF35700 (4.7 μCi/174 kBq) single intravenous micro-dose
Eligibility Criteria
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Inclusion Criteria
* Body Mass Index (BMI) of ≥18.5 and ≤30 kg/m2
* Subject must be in good general health as assessed using medical history, clinical laboratory tests, and physical examination
Exclusion Criteria
* The subject must not be a CYP2D6 or a CYP2C19 poor metabolizer
18 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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Covance
Leeds, , United Kingdom
Countries
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Other Identifiers
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17482A
Identifier Type: -
Identifier Source: org_study_id
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