Pharmacokinetics of Lanabecestat (LY3314814) in Subjects With Impaired Renal Function
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- Sponsor
- Eli Lilly and Company
- Locations
- 3
- Primary Endpoint
- Pharmacokinetics (PK): Area Under The Concentration Versus Time Curve From Zero To Infinity (AUC[0-∞]) for Lanabecestat
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to — (Adult, Older Adult)
- Sex
- 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
- •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
Arms & Interventions
Lanabecestat Control
Lanabecestat administered orally to participants with normal renal function
Intervention: Lanabecestat (Drug)
Lanabecestat Severe Renal Impairment
Lanabecestat administered orally to participants with severe renal impairment, not on dialysis
Intervention: Lanabecestat (Drug)
Lanabecestat Severe Renal Impairment
Lanabecestat administered orally to participants with severe renal impairment, not on dialysis
Intervention: Iohexol (Drug)
Outcomes
Primary Outcomes
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
PK: Maximum Observed Drug Concentration (Cmax) of Lanabecestat
Time Frame: Baseline through 168 hours after the administration of study drug
PK: Cmax of Lanabecestat
Secondary Outcomes
No secondary outcomes reported