Conditions: Major Depressive Disorder
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 20
Healthy volunteers: yes

Brief summary:
LY2216684 is being studied as adjunctive treatment for major depressive disorder (MDD) in participants who are partial responders to selective serotonin reuptake inhibitors (SSRIs). Sertraline is a medication that is widely used to treat MDD and is a known substrate of cytochrome P450s (CYP450s), including CYP450 2D6 (CYP2D6), CYP450 2C19 (CYP2C19), CYPP450 3A4 (CYP3A4), and a modest inhibitor of CYP2D6. Based on the diversity of hepatic metabolic clearance pathways for LY2216684 and its elimination by the kidney, it is expected that CYP2D6 inhibition by sertraline will not result in a substantial change in the pharmacokinetic (PK) profile of LY2216684. LY2216684 is only known to be a moderate inhibitor of CYP2C19, so it is unlikely that coadministration of sertraline with LY2216684 will result in a clinically meaningful change in the PK of sertraline. This study is being conducted to test these hypotheses.

Detailed description:

Arms:
arm 1: Period 1: LY2216684 18 milligram (mg) oral (po) dose on Days 1-3.

Period 2: Sertraline 50 mg po dose on Day 4 followed by sertraline 100 mg po dose on Days 5-10.

Period 3: LY2216684 18 mg po dose + sertraline 100 mg po dose on Days 11-13.

Interventions: intervention 1: LY2216684 intervention 2: Sertraline
Intervention descriptions: intervention 1: po administration intervention 2: po administration

Protocol document: