A drug-Drug interaction study of Lanabecestat (LY3314814) in healthy participants

Study identifier:16014

ClinicalTrials.gov identifier:NCT02406261

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Study to Characterize LY3314814 Pharmacokinetics as a Function of Dosing Duration and to Determine the Effect of LY3314814 on the Pharmacokinetics of CYP3A Substrates in Healthy Subjects

Medical condition

Healthy

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Lanabecestat, Simvastatin, Midazolam, Donepezil

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 30 Apr 2015

Primary Completion Date: 31 Aug 2015

Study Completion Date: 31 Aug 2015

Study design

Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Other

Verification:

Verified 01 Oct 2019 by AstraZeneca

Collaborators

Eli Lilly and Company

Inclusion and exclusion criteria

No locations available

Arms	Assigned Interventions
Experimental: Cohort A 500 microgram (mcg) midazolam, single oral dose on Days 1, 17, and 35; 20 mg simvastatin, single oral dose on Days 2 and 36; 250 microgram (mcg) midazolam, intravenous (IV) on Days 3 and 37; 50 mg lanabecestat, single oral dose on Day 4; 50 mg lanabecestat, single oral dose, Days 10 to 37	Drug: Lanabecestat 50 mg lanabecestat will be administered orally as 1 × 50-mg tablet Other Name: LY3314814 Other Name: AZD3293 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
Experimental: Cohort B 5 mg donepezil, single oral dose on Day 1, Period 1; 50 mg lanabecestat, single oral dose Days 1 to 43, Period 2; 5 mg donepezil, single oral dose on Day 28, Period 2	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 Other Name: LY3314814 Other Name: AZD3293

Arms

Assigned Interventions

Experimental: Cohort A
500 microgram (mcg) midazolam, single oral dose on Days 1, 17, and 35; 20 mg simvastatin, single oral dose on Days 2 and 36; 250 microgram (mcg) midazolam, intravenous (IV) on Days 3 and 37; 50 mg lanabecestat, single oral dose on Day 4; 50 mg lanabecestat, single oral dose, Days 10 to 37

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

Other Name: LY3314814

Other Name: AZD3293

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

Experimental: Cohort B
5 mg donepezil, single oral dose on Day 1, Period 1; 50 mg lanabecestat, single oral dose Days 1 to 43, Period 2; 5 mg donepezil, single oral dose on Day 28, Period 2

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

Other Name: LY3314814

Other Name: AZD3293

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center 1-877-240-9479

[email protected]

Investigators

Principal Investigator

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)