Pharmacokinetic Properties of Idalopirdine (Lu AE58054) in Subjects With and Without Impaired Kidney Function
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
2 other identifiers
interventional
16
1 country
1
Brief Summary
The purpose of this study is to evaluate the pharmacokinetics properties of idalopirdine following multiple dosing in patients with renal impairment and compare to those in healthy subjects
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 alzheimer-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 13, 2015
CompletedFirst Posted
Study publicly available on registry
January 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedNovember 9, 2015
November 1, 2015
8 months
January 13, 2015
November 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Area under the LuAE58054 plasma concentration-time curve from time zero to 24h(AUC0-24)
Day 10
Maximum observed concentration (Cmax) of Lu AE58054
0-12 hours day 10
Study Arms (4)
Idalopirdine (Lu AE58054) 60 mg (Group A)
EXPERIMENTAL8 patients with severe renal impairment and not on dialysis
Idalopirdine (Lu AE58054) 60 mg (Group B)
EXPERIMENTAL8 healthy subjects
Idalopirdine (Lu AE58054) 60 mg (Group C)
EXPERIMENTALGroup 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 (Group D)
EXPERIMENTALGroup 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
Interventions
encapsulated film-coated tablets for oral use once daily for 10 days
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- H. Lundbeck A/Slead
Study Sites (1)
DE801
München, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2015
First Posted
January 16, 2015
Study Start
January 1, 2015
Primary Completion
September 1, 2015
Last Updated
November 9, 2015
Record last verified: 2015-11