Pharmacokinetics of Lu AF35700 in Subjects With Renal Impairment

Lundbeck

Status and phase: Terminated; Phase 1

Conditions: Renal Failure

Treatments: Drug: Lu AF35700

Study type: Interventional

Funder types: Industry

Identifiers

NCT03241147

17278A

Details and patient eligibility

About

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

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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23 participants in 4 patient groups

Subjects with severe renal impairment (Group A)

Experimental group

Treatment:

Drug: Lu AF35700

Healthy subjects (Group B)

Experimental group

Treatment:

Drug: Lu AF35700

Subjects with moderate renal impairment (Group C)

Experimental group

Treatment:

Drug: Lu AF35700

Subjects with mild renal impairment (Group D)

Experimental group

Treatment:

Drug: Lu AF35700