Pharmacokinetics of Lu AF35700 in Subjects With Renal Impairment
- Registration Number
- NCT03241147
- Lead Sponsor
- H. Lundbeck A/S
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 23
-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
-The subject has previously been dosed with Lu AF35700
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Subjects with severe renal impairment (Group A) Lu AF35700 - Healthy subjects (Group B) Lu AF35700 - Subjects with moderate renal impairment (Group C) Lu AF35700 - Subjects with mild renal impairment (Group D) Lu AF35700 -
- Primary Outcome Measures
Name Time Method AUC0-inf Predose to day 57 postdose Area under the Lu AF35700 plasma concentration-time curve from zero to infinity
Cmax Predose to day 57 postdose Maximum observed plasma concentration of Lu AF35700
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
APEX
🇩🇪Munich, Germany