AZD2066 Cocktail Study

Phase 1

Completed

• Conditions: Chronic Pain
• Interventions: Drug: AZD2066; Drug: Caffeine; Drug: Tolbutamide; Drug: Omeprazole Tablet, 20 mg; Drug: Midazolam Tablet, 7.5 mg

• Registration Number: NCT00930306
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-29
• Study First Submitted QC: 2009-06-29
• Study First Posted: 2009-06-30
• Study Completion: 2009-09
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-23
• Last Update Posted: 2009-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Omeprazole Tablet, 20 mg	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
1	Midazolam Tablet, 7.5 mg	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
1	Caffeine	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
1	Tolbutamide	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
1	AZD2066	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

Primary Outcome Measures

Name	Time	Method
PK variables	Frequent sampling occasions during

Secondary Outcome Measures

Name	Time	Method
Safety variables (adverse events, blood pressure, pulse, safety lab)	Frequent sampling occasions during

Trial Locations

Locations (1)

Research Site; 🇬🇧 Manchester, United Kingdom