Phase 1
Completed N=82
A Drug-Drug Interaction Study of Lanabecestat (LY3314814) in Healthy Participants
Healthy
Source: ClinicalTrials.gov NCT02406261 ↗
Enrolled (actual)
82
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcomePrimary: Pharmacokinetic (PK): Area Under the Curve Zero to Infinity (AUC[0-∞]) for LY3314814 — 3200 Nanogram * hour per milliliter (ng*h/mL)
Summary
The purpose of this study is to study the effect of lanabecestat on how the body absorbs and processes 3 other medications, midazolam, simvastatin and donepezil and how these 3 medications affect lanabecestat when they are taken together. This study is in 2 cohorts, Cohort A is approximately 44 days long and Cohort B about 70 days only. The screening visit is required within 30 days prior to the start on the study
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetic (PK): Area Under the Curve Zero to Infinity (AUC[0-∞]) for LY3314814 |
3200 | — |
| PRIMARY PK Profile for Simvastatin: AUC(0-∞) |
15.1; 21.2 | — |
| PRIMARY PK Profile for Midazolam: AUC(0-∞) Oral and IV Dose |
6.53; 6.24; 5.59; 11.4; 11.6 | — |
| PRIMARY PK Profile for Donepezil: AUC(0-∞) |
271; 285 | — |
| SECONDARY Number of Participants With One or More Serious Adverse Events(s) Considered by the Investigator to be Related to Study Drug Administration |
0; 0 | — |
| SECONDARY Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) |
0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Overtly healthy and either sterile or, male and prepared to use an approved method of contraception
- Have a body mass index (BMI) at screening of 19.0 to 32.0 kilogram per square meter (kg/m^2)
Exclusion Criteria
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may put the subject at risk because of participation in the study, may influence the results, or may limit the subject's ability to participate in the study
- History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
- History of previous or ongoing psychiatric disease/condition
Data sourced from ClinicalTrials.gov (NCT02406261). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.