AZD2066 Cocktail Study

Chronic Pain Clinical Trial

Official title:

A Phase I, Open Label, Multi Centre Study in Healthy Volunteers to Estimate the Effect of Multiple Doses of AZD2066 on the Activity of CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6 and CYP3A4 by Administering a Cocktail of Caffeine, Bupropion, Tolbutamide, Omeprazole, Metoprolol and Midazolam

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00930306
• Other study ID #: D0475C00011
• Status: Completed
• Phase: Phase 1
• First received: June 29, 2009
• Last updated: October 23, 2009
• Start date: June 2009
• Est. completion date: September 2009

Study information

• Verified date: October 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Drug:
• AZD2066
12 doses, Given as capsule, 2 mg & 8 mg
• Caffeine
2 doses, Given as Tablet, 2x50 mg
• Tolbutamide
2 doses, Given as Tablet, half of 500 mg
• Omeprazole Tablet, 20 mg
2 doses, Given as Tablet, 20 mg
• Midazolam Tablet, 7.5 mg
2 doses, Given as Tablet, 7.5 mg

Locations

Country	Name	City	State
United Kingdom	Research Site	London
United Kingdom	Research Site	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK variables		Frequent sampling occasions during	No
Secondary	Safety variables (adverse events, blood pressure, pulse, safety lab)		Frequent sampling occasions during	Yes