Back to resultsPharmacokinetics of Lu AF35700 in Subjects With Renal Impairment
Primary Purpose
Renal Failure
Status
Terminated
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Lu AF35700
Sponsored by
About this trial
This is an interventional treatment trial for Renal Failure
Eligibility Criteria
Inclusion Criteria:
-Healthy subjects: The subject has a Glomerular Filtration Rate as based on creatinine clearance (CLCr) ≥90 mL/min (estimated by the Cockcroft-Gault method)
-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:
-The subject has previously been dosed with Lu AF35700
Sites / Locations
- APEX
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Subjects with severe renal impairment (Group A)
Healthy subjects (Group B)
Subjects with moderate renal impairment (Group C)
Subjects with mild renal impairment (Group D)
Arm Description
Outcomes
Primary Outcome Measures
AUC0-inf
Area under the Lu AF35700 plasma concentration-time curve from zero to infinity
Cmax
Maximum observed plasma concentration of Lu AF35700
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03241147
Brief Title
Pharmacokinetics of Lu AF35700 in Subjects With Renal Impairment
Official Title
Interventional, Open Label, Reduced/Staged, Single Dose Study Investigating the Pharmacokinetic Properties of Lu AF35700 in Subjects With Renal Impairment and in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
New data; the study was terminated based on new efficacy data
Study Start Date
July 25, 2017 (Actual)
Primary Completion Date
July 17, 2019 (Actual)
Study Completion Date
July 24, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the pharmacokinetics of Lu AF35700 after a single dose tablet to subjects with renal impairment (kidney insufficiency) and compare that with healthy subjects
Detailed Description
If the initial data shows a substantial effect in subjects with severe renal impairment, the study will be expanded to include subjects with intermediate level (mild and moderate) of renal impairment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subjects with severe renal impairment (Group A)
Arm Type
Experimental
Arm Title
Healthy subjects (Group B)
Arm Type
Experimental
Arm Title
Subjects with moderate renal impairment (Group C)
Arm Type
Experimental
Arm Title
Subjects with mild renal impairment (Group D)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Lu AF35700
Intervention Description
Single dose, 10 mg film coated tablet
Primary Outcome Measure Information:
Title
AUC0-inf
Description
Area under the Lu AF35700 plasma concentration-time curve from zero to infinity
Time Frame
Predose to day 57 postdose
Title
Cmax
Description
Maximum observed plasma concentration of Lu AF35700
Time Frame
Predose to day 57 postdose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
-Healthy subjects: The subject has a Glomerular Filtration Rate as based on creatinine clearance (CLCr) ≥90 mL/min (estimated by the Cockcroft-Gault method)
-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:
-The subject has previously been dosed with Lu AF35700
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@Lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
APEX
City
Munich
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetics of Lu AF35700 in Subjects With Renal Impairment
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