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

Phase 1

Withdrawn

• Conditions: Renal Insufficiency
• Interventions: Drug: Lanabecestat; Drug: Iohexol

• Registration Number: NCT03545087
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-22
• Study First Submitted QC: 2018-05-22
• Status Verified: 2018-06
• Study Start: 2018-06
• Study First Posted: 2018-06-04
• Last Update Submitted: 2018-06-26
• Last Update Posted: 2018-06-28
• Primary Completion: 2019-01
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lanabecestat Severe Renal Impairment	Lanabecestat	Lanabecestat administered orally to participants with severe renal impairment, not on dialysis
Lanabecestat Severe Renal Impairment	Iohexol	Lanabecestat administered orally to participants with severe renal impairment, not on dialysis
Lanabecestat Control	Lanabecestat	Lanabecestat administered orally to participants with normal renal function

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Area Under The Concentration Versus Time Curve From Zero To Infinity (AUC[0-∞]) for Lanabecestat	Baseline through 168 hours after the administration of study drug	PK: AUC(0-∞) for Lanabecestat
PK: Maximum Observed Drug Concentration (Cmax) of Lanabecestat	Baseline through 168 hours after the administration of study drug	PK: Cmax of Lanabecestat

Trial Locations

Locations (3)

Orange County Research Center; 🇺🇸 Tustin, California, United States

Clinical Pharmacology of Miami; 🇺🇸 Miami, Florida, United States

Orlando Clinical Research Ctr.; 🇺🇸 Orlando, Florida, United States