Pharmacokinetics of Lu AF35700 in Subjects With Renal Impairment
NCT ID: NCT03241147
Last Updated: 2019-09-30
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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TERMINATED
PHASE1
23 participants
INTERVENTIONAL
2017-07-25
2019-07-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Subjects with severe renal impairment (Group A)
Lu AF35700
Single dose, 10 mg film coated tablet
Healthy subjects (Group B)
Lu AF35700
Single dose, 10 mg film coated tablet
Subjects with moderate renal impairment (Group C)
Lu AF35700
Single dose, 10 mg film coated tablet
Subjects with mild renal impairment (Group D)
Lu AF35700
Single dose, 10 mg film coated tablet
Interventions
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Lu AF35700
Single dose, 10 mg film coated tablet
Eligibility Criteria
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Inclusion Criteria
-Subjects with renal impairment: The subject has any form of renal dysfunction which includes polycystic kidney disease
The subject is classified as having renal impairment at Screening according to Cockroft-Gault method for estimating creatinine clearance:
Severe: CLCr ≤ 29 mL/min Moderate: 30 mL/min ≤ CLCr ≤ 59 mL/min Mild: 60 mL/min ≤ CLCr ≤ 89 mL/min
Exclusion Criteria
18 Years
70 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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APEX
Munich, , Germany
Countries
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Other Identifiers
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17278A
Identifier Type: -
Identifier Source: org_study_id
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