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

June 26, 2018 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Tustin, California, United States, 92780
        • Orange County Research Center
    • Florida
      • Miami, Florida, United States, 33014
        • Clinical Pharmacology of Miami
      • Orlando, Florida, United States, 32809
        • Orlando Clinical Research Ctr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lanabecestat Control
Lanabecestat administered orally to participants with normal renal function
Drug: Lanabecestat
Administered orally
Other Names:
  • LY3314814
Experimental: Lanabecestat Severe Renal Impairment
Lanabecestat administered orally to participants with severe renal impairment, not on dialysis
Drug: Lanabecestat
Administered orally
Other Names:
  • LY3314814
Drug: Iohexol
Administered intravenously. Administration is at investigator's discretion in participants with severe renal impairment.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Collaborators

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2018

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

May 22, 2018

First Submitted That Met QC Criteria

May 22, 2018

First Posted (Actual)

June 4, 2018

Study Record Updates

Last Update Posted (Actual)

June 28, 2018

Last Update Submitted That Met QC Criteria

June 26, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16007
  • I8D-MC-AZEN (Other Identifier: Eli Lilly and Company)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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