AZD2066 Cocktail Study

NCT00930306 | Completed Phase 1

• 1 other identifier: D0475C00011
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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

Conditions

Chronic Pain

Keywords

Chronic Pain; AZD2066

Outcome Measures

Primary Outcomes (1)

• PK variables

  Frequent sampling occasions during

Secondary Outcomes (1)

• Safety variables (adverse events, blood pressure, pulse, safety lab)

  Frequent sampling occasions during

Study Arms (1)

1

EXPERIMENTAL

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

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

Interventions

AZD2066 DRUG

12 doses, Given as capsule, 2 mg \& 8 mg

1

Caffeine DRUG

2 doses, Given as Tablet, 2x50 mg

Also known as: Pharmapac/ProPlus®

1

Tolbutamide DRUG

2 doses, Given as Tablet, half of 500 mg

Also known as: Actavis /generic

1

Omeprazole Tablet, 20 mg DRUG

2 doses, Given as Tablet, 20 mg

Also known as: AstraZeneca/Losec® MUPS®

1

Midazolam Tablet, 7.5 mg DRUG

2 doses, Given as Tablet, 7.5 mg

Also known as: Roche/generic

1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (2)

Research Site

London, United Kingdom

Location

Research Site

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

AZD2066; Caffeine; Tolbutamide; Drugs, Generic; Omeprazole; Midazolam

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfonylurea Compounds; Urea; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pharmaceutical Preparations; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Pyridines; Heterocyclic Compounds, 1-Ring; Benzimidazoles; Benzodiazepines; Benzazepines

Study Officials

• Biljana Lilja

  AstraZeneca R&D, Södertälje, Sweden

  STUDY DIRECTOR

• Simon Constable

  ICON Development Solutions, Manchester, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 29, 2009
• First Posted: June 30, 2009
• Study Start: June 1, 2009
• Study Completion: September 1, 2009
• Last Updated: October 27, 2009

Record last verified: 2009-10

Locations

GB (2)