Pharmacokinetic Properties of Idalopirdine (Lu AE58054) in Subjects With and Without Impaired Kidney Function
NCT ID: NCT02340195
Last Updated: 2015-11-09
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
16 participants
INTERVENTIONAL
2015-01-31
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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Idalopirdine (Lu AE58054) 60 mg (Group A)
8 patients with severe renal impairment and not on dialysis
Idalopirdine (Lu AE58054) 60 mg
encapsulated film-coated tablets for oral use once daily for 10 days
Idalopirdine (Lu AE58054) 60 mg (Group B)
8 healthy subjects
Idalopirdine (Lu AE58054) 60 mg
encapsulated film-coated tablets for oral use once daily for 10 days
Idalopirdine (Lu AE58054) 60 mg (Group C)
Group C will not be tested, if severe renal impairment does not alter the pharmacokinetics to a clinically relevant extent, based on results from group A and B
8 patients with moderate renal impairment
Idalopirdine (Lu AE58054) 60 mg
encapsulated film-coated tablets for oral use once daily for 10 days
Idalopirdine (Lu AE58054) 60 mg (Group D)
Group D will not be tested, if severe renal impairment does not alter the pharmacokinetics to a clinically relevant extent, based on results from group A and B
8 patients with mild renal impairment
Idalopirdine (Lu AE58054) 60 mg
encapsulated film-coated tablets for oral use once daily for 10 days
Interventions
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Idalopirdine (Lu AE58054) 60 mg
encapsulated film-coated tablets for oral use once daily for 10 days
Eligibility Criteria
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Inclusion Criteria
* BMI ≥18.5 kg/m2 and ≤32 kg/m2 at the Screening Visit.
* Group A: Patients with severe renal impairment renal impairment (creatinine clearance (ClCr) ≤29 mL/min)
* Group B: Healthy subjects with normal kidney function (creatinine clearance (ClCr) ≥90 mL/min, inclusive)
* Group C: Patients with moderate renal impairment ((creatinine clearance between 30 - 59 mL/min, inclusive)
* Group D: Patients with mild renal impairment (Creatinine clearance between 60 - 89 mL/min, inclusive)
Exclusion Criteria
50 Years
75 Years
ALL
Yes
Sponsors
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H. Lundbeck A/S
INDUSTRY
Responsible Party
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Locations
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DE801
München, , Germany
Countries
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Other Identifiers
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2012-005647-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
14916A
Identifier Type: -
Identifier Source: org_study_id
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