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A Drug-Drug Interaction Study of Lanabecestat (LY3314814) in Healthy Participants

NCT02406261 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2019-11-04

Study results available
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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

Conditions

  • Healthy

Interventions

DRUG

Lanabecestat

50 mg lanabecestat will be administered orally as 1 × 50-mg tablet

DRUG

Simvastatin

20 mg simvastatin will be administered orally as 1 × 20-mg tablet

DRUG

Midazolam

500 mcg midazolam will be administered orally as 0.25 mL of 2-mg/mL syrup

DRUG

Midazolam

250 mcg midazolam will be administered intravenous (IV) as 0.25 mL of 1-mg/mL injection solution

DRUG

Donepezil

5 mg donepezil will be administered orally as 1 × 5-mg tablet

DRUG

Lanabecestat

50 mg lanabecestat will be administered orally as 1 × 50-mg tablet

Sponsors & Collaborators

Principal Investigators

  • 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) · Eli Lilly and Company

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02406261 on ClinicalTrials.gov