Renal Insufficiency
Conditions
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.
Interventions
DRUGLanabecestat
Administered orally
DRUGIohexol
Administered intravenously. Administration is at investigator's discretion in participants with severe renal impairment.
Sponsors
AstraZeneca
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed