AZD2066 Cocktail Study

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Chronic Pain

Treatments: Drug: Caffeine; Drug: Omeprazole Tablet, 20 mg; Drug: AZD2066; Drug: Midazolam Tablet, 7.5 mg; Drug: Tolbutamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00930306

D0475C00011

Details and patient eligibility

About

The aims of this study are to examine the effect of repeated doses of AZD2066 and of caffeine, bupropion, tolbutamide, omeprazole, metoprolol and midazolam on the blood concentrations of each other

Enrollment: 15 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provision of informed consent prior to any study-specific procedures
• Healthy volunteers with BMI between 18 and 30 kg/m2
• Medical and surgical history and physical examination without any clinically significant findings
• Non smokers or past smokers who have stopped smoking within the last 6 months.

Exclusion criteria

• History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, personality disorder or other significant psychiatric disorders or any other major disorder that may interfere with the objectives of the study, as judged by the Investigator
• Clinically significant illness as judged by the Investigator, within four weeks before the first administration of investigational product.
• Female subjects who have a positive pregnancy test or who are pregnant or breast-feeding

Trial design

15 participants in 1 patient group

1

Experimental group

Description:

12 AZD2066 Capsule, 2 mg \& 8 mg 2 Caffeine Tablet, 2 x 50 mg 2 Tolbutamide Tablet, half of 500 mg 2 Omeprazole Tablet, 20 mg 2 Midazolam Tablet, 7.5 mg 2 Metoprolol Tablet, 100 mg 2 Bupropion Tablet, 150 mg

Treatment:

Drug: Midazolam Tablet, 7.5 mg

Drug: Tolbutamide

Drug: AZD2066

Drug: Omeprazole Tablet, 20 mg

Drug: Caffeine