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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 November 2015 |
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Main ID: |
NCT02340195 |
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Date of registration:
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13/01/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Pharmacokinetic Properties of Idalopirdine (Lu AE58054) in Subjects With and Without Impaired Kidney Function
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Scientific title:
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Interventional, Single-site, Open-label, Reduced/Staged, Multiple-dose Study Investigating the Pharmacokinetic Properties of Idalopirdine (Lu AE58054) in Patients With Renal Impairment and in Healthy Subjects |
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Date of first enrolment:
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January 2015 |
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Target sample size:
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16 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02340195 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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Germany
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Men or women aged between 50 and 75 years (inclusive)
- 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:
•The subject has taken disallowed medication <1 week prior to the first dose of IMP or <5
half-lives prior to the first dose of IMP for any disallowed medication taken, whichever
is longer)
Other protocol defined inclusion and exclusion criteria do apply
Age minimum:
50 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Alzheimer Disease
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Intervention(s)
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Drug: Idalopirdine (Lu AE58054) 60 mg
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Primary Outcome(s)
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Area under the LuAE58054 plasma concentration-time curve from time zero to 24h(AUC0-24)
[Time Frame: Day 10]
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Maximum observed concentration (Cmax) of Lu AE58054
[Time Frame: 0-12 hours day 10]
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Secondary ID(s)
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14916A
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2012-005647-25
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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