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

AstraZeneca46 enrolled

Overview

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.)

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

AZD6765DRUG

IV solution

midazolamDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * BMI between 19-30 Exclusion Criteria: * Significant result for C-SSRS at screening or baseline * Single arm preference for IV procedures

Locations (1)

Research Site

Overland Park, Kansas, United States

Outcomes

Primary Outcomes

Pharmacokinetic parameters to be calculated from midazolam and AZD6765 plasma concentrations

Time frame: on Day -1 and Day 6

Secondary Outcomes

Safety variables (adverse events, vital signs, physical and neurological examinations, clinical laboratory assessments, 12-lead ECG, C-SSRS, CADSS, and VAS scales)

Time frame: will be collected from the time of informed consent (Visit 1) until completion of the follow-up visit.

Optional Genetic sampling

Time frame: at admission Day -2

Exploratory - renal biomarkers in urine

Time frame: At admission Day -2 until follow up visit

Data from ClinicalTrials.gov

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