Conditions: Healthy
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 82
Healthy volunteers: yes

Brief 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

Detailed description:
Astra Zeneca (AZ) registered this trial as sponsor. In July, 2015, sponsorship changed to Eli Lilly and Company (Lilly). In August, 2015, AZ transferred this trial to Lilly's ClinicalTrials.gov account and Lilly updated the record. This trial is not an applicable trial under the Food and Drug Administration Amendments Act of 2007 (FDAAA).

Arms:
arm 1: 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 arm 2: 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

Interventions: intervention 1: Lanabecestat intervention 2: Simvastatin intervention 3: Midazolam intervention 4: Midazolam intervention 5: Donepezil intervention 6: Lanabecestat
Intervention descriptions: intervention 1: 50 mg lanabecestat will be administered orally as 1 × 50-mg tablet intervention 2: 20 mg simvastatin will be administered orally as 1 × 20-mg tablet intervention 3: 500 mcg midazolam will be administered orally as 0.25 mL of 2-mg/mL syrup intervention 4: 250 mcg midazolam will be administered intravenous (IV) as 0.25 mL of 1-mg/mL injection solution intervention 5: 5 mg donepezil will be administered orally as 1 × 5-mg tablet intervention 6: 50 mg lanabecestat will be administered orally as 1 × 50-mg tablet

Protocol document: