Pharmacokinetics of Lu AF35700 in Subjects With Renal Impairment

Interventional, Open Label, Reduced/Staged, Single Dose Study Investigating the Pharmacokinetic Properties of Lu AF35700 in Subjects With Renal Impairment and in Healthy Subjects

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03241147

Enrollment

Registered

2017-08-07

Start date

2017-07-25

Completion date

2019-07-24

Last updated

2019-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Failure

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.

Interventions

DRUGLu AF35700

Single dose, 10 mg film coated tablet

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026