Pharmacokinetics of Lu AF35700 in Subjects With Renal Impairment

• Status: Terminated
• Trial end date: 2019-07-24
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: H. Lundbeck A/S

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