A Study in Healthy Volunteers to Assess Effect of AZD6765 on Midazolam Blood Levels

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: AZD6765; Drug: midazolam

Study type: Interventional

Funder types: Industry

Identifiers

NCT01069822

D6702C00008

Details and patient eligibility

About

The main purpose of this study is to evaluate the effect repeated doses of AZD6765 (a drug being developed for the treatment of patients with severe major depressive disorder) has on the PK (pharmacokinetic) profile of Midazolam. (The PK profile is how the drug leaves your body and acts in the body.)

Enrollment: 46 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• BMI between 19-30

Exclusion criteria

• Significant result for C-SSRS at screening or baseline
• Single arm preference for IV procedures

Trial design

46 participants in 2 patient groups

1

Experimental group

Description:

midazolam + AZD6765 IV solution

Treatment:

Drug: AZD6765

Drug: midazolam

2

Active Comparator group

Treatment:

Drug: midazolam