A Study of Lanabecestat in Participants With Severe Kidney Impairment Compared to Healthy Participants

Lilly

Status and phase: Withdrawn; Phase 1

Conditions: Renal Insufficiency

Treatments: Drug: Iohexol; Drug: Lanabecestat

Study type: Interventional

Funder types: Industry

Identifiers

NCT03545087

16007

I8D-MC-AZEN (Other Identifier)

Details and patient eligibility

About

The purpose of the study is to determine whether lanabecestat can be safely prescribed in participants with kidney impairment without a dose adjustment.

Participants will be on study for up to 6 weeks; this includes a 2-week screening and a follow-up about 10 days after final drug administration.

Sex: All

Ages: 35+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Have a body mass index (BMI) of 19 to 40 kilograms per meter square (kg/m²)

Exclusion criteria

• Have a history of or current significant ophthalmic disease, particularly any eye problem involving the retina
• Have moderate or severe vitiligo or any other clinically significant disorder of skin or hair pigmentation
• Have acute unstable neuropsychiatric disease
• Have active or uncontrolled neurologic disease, or clinically significant head injury

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups

Lanabecestat Control

Experimental group

Description:

Lanabecestat administered orally to participants with normal renal function

Treatment:

Drug: Lanabecestat

Lanabecestat Severe Renal Impairment

Experimental group

Description:

Lanabecestat administered orally to participants with severe renal impairment, not on dialysis

Treatment:

Drug: Lanabecestat

Drug: Iohexol