AZD2066 Cocktail Study

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Masking: None (Open Label)

Interventions

  • Drug: AZD2066
    • 12 doses, Given as capsule, 2 mg & 8 mg
  • Drug: Caffeine
    • 2 doses, Given as Tablet, 2×50 mg
  • Drug: Tolbutamide
    • 2 doses, Given as Tablet, half of 500 mg
  • Drug: Omeprazole Tablet, 20 mg
    • 2 doses, Given as Tablet, 20 mg
  • Drug: Midazolam Tablet, 7.5 mg
    • 2 doses, Given as Tablet, 7.5 mg

Arms, Groups and Cohorts

  • Experimental: 1
    • 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

Clinical Trial Outcome Measures

Primary Measures

  • PK variables
    • Time Frame: Frequent sampling occasions during

Secondary Measures

  • Safety variables (adverse events, blood pressure, pulse, safety lab)
    • Time Frame: Frequent sampling occasions during

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Provider of Information About this Clinical Study
    • MSD, AstraZeneca Pharmaceuticals
  • Overall Official(s)
    • Biljana Lilja, Study Director, AstraZeneca R&D, Södertälje, Sweden
    • Simon Constable, Principal Investigator, ICON Development Solutions, Manchester, UK

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