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WithdrawnNCT03545087Updated Jun 28, 2018

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

A Phase 1 interventional study of Lanabecestat and Iohexol in Renal Insufficiency, sponsored by Eli Lilly and Company. Withdrawn at 3 sites in United States. Open to participants aged 35 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-28.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

Why this study was withdrawn
Stopped for futility. Phase 3 studies not likely to meet primary endpoints.
Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
35 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Renal Insufficiency

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03

In context

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

Browse Renal Insufficiency studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Lanabecestat Control

    Lanabecestat administered orally to participants with normal renal function

    Drug: Lanabecestat

  • Experimental
    Lanabecestat Severe Renal Impairment

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

    Drug: Lanabecestat · Drug: Iohexol

Interventions

  • DrugLanabecestat

    Administered orally

    Also known as: LY3314814

  • DrugIohexol

    Administered intravenously. Administration is at investigator's discretion in participants with severe renal impairment.

06

What researchers measure

Primary outcomes

  1. Pharmacokinetics (PK): Area Under The Concentration Versus Time Curve From Zero To Infinity (AUC[0-∞]) for Lanabecestat

    PK: AUC(0-∞) for Lanabecestat

    Time frame: Baseline through 168 hours after the administration of study drug

  2. PK: Maximum Observed Drug Concentration (Cmax) of Lanabecestat

    PK: Cmax of Lanabecestat

    Time frame: Baseline through 168 hours after the administration of study drug

07

Study locations

3 sites
  • Orange County Research Center
    Tustin, California 92780, United States
  • Clinical Pharmacology of Miami
    Miami, Florida 33014, United States
  • Orlando Clinical Research Ctr.
    Orlando, Florida 32809, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03545087
Lead sponsor
Eli Lilly and Company
Collaborators
AstraZeneca
Responsible party
Sponsor
First posted
Jun 4, 2018
Start date
Jun 2018 (estimated)
Primary completion
Jan 2019 (estimated)
Completion
Jan 2019 (estimated)
Last update
Jun 28, 2018

Study contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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