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Completed

NCT Number: NCT00930306

AZD2066 Cocktail Study

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

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, London, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD2066

Drug

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

Caffeine

Drug

2 doses, Given as Tablet, 2x50 mg

Other names: Pharmapac/ProPlus®

tolbutamide

Drug

2 doses, Given as Tablet, half of 500 mg

Other names: Actavis /generic

Omeprazole Tablet, 20 mg

Drug

2 doses, Given as Tablet, 20 mg

Other names: AstraZeneca/Losec® MUPS®

Midazolam Tablet, 7.5 mg

Drug

2 doses, Given as Tablet, 7.5 mg

Other names: Roche/generic

Primary outcomes

  1. PK variables

    Time frame: Frequent sampling occasions during

Secondary outcomes

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

    Time frame: Frequent sampling occasions during

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2009
Study completion
2009
First posted
Jun 30, 2009
Registry last updated
Oct 27, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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