Pharmacokinetics of Lu AF35700 in Subjects With Renal Impairment

Phase 1TerminatedNCT03241147

H. Lundbeck A/S23 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Renal Failure

Interventions

Lu AF35700DRUG

Single dose, 10 mg film coated tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

APEX

Munich, Germany

Outcomes

Primary Outcomes

AUC0-inf

Area under the Lu AF35700 plasma concentration-time curve from zero to infinity

Time frame: Predose to day 57 postdose

Cmax

Maximum observed plasma concentration of Lu AF35700

Time frame: Predose to day 57 postdose

Data from ClinicalTrials.gov

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