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

Renal Insufficiency Clinical Trial

Official title:

Pharmacokinetics of Lanabecestat (LY3314814) in Subjects With Impaired Renal Function

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03545087
• Other study ID #: 16007
• Secondary ID: I8D-MC-AZEN
• Status: Withdrawn
• Phase: Phase 1
• Start date: June 2018
• Est. completion date: January 2019

Study information

• Verified date: June 2018
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Renal Insufficiency

Intervention

Drug:
• Lanabecestat
Administered orally
• Iohexol
Administered intravenously. Administration is at investigator's discretion in participants with severe renal impairment.

Locations

Country	Name	City	State
United States	Clinical Pharmacology of Miami	Miami	Florida
United States	Orlando Clinical Research Ctr.	Orlando	Florida
United States	Orange County Research Center	Tustin	California

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Area Under The Concentration Versus Time Curve From Zero To Infinity (AUC[0-8]) for Lanabecestat	PK: AUC(0-8) for Lanabecestat	Baseline through 168 hours after the administration of study drug
Primary	PK: Maximum Observed Drug Concentration (Cmax) of Lanabecestat	PK: Cmax of Lanabecestat	Baseline through 168 hours after the administration of study drug