Status:
TERMINATED
Pharmacokinetics of Lu AF35700 in Subjects With Renal Impairment
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Renal Failure
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- The subject has previously been dosed with Lu AF35700
Key Trial Info
Start Date :
July 25 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 24 2019
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT03241147
Start Date
July 25 2017
End Date
July 24 2019
Last Update
September 30 2019
Active Locations (1)
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1
APEX
Munich, Germany