Effect of Multiple Doses of AZD6280 on the Pharmacokinetics of Midazolam (CYP3A4) and Caffeine (CYP1A2) (CYP)

A Phase I Open-labeled, Fixed Sequence Study to Determine the Effect of Multiple Doses of AZD6280 on the Pharmacokinetics of Midazolam (CYP3A4) and Caffeine (CYP1A2)

The aim of this study is to investigate the effects of taking repeated doses of AZD6280 on the blood levels of midazolam and caffeine in healthy volunteers

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: AZD6280; Drug: Midazolam; Drug: Caffeine

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy male subjects aged 18 to 45 years (inclusive) on Day 1.

Exclusion Criteria:

• Clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, hematology or urinalysis as judged by the investigator and/or sponsor.
• Enrollment in another concurrent investigational study or intake of an investigational drug within 3 months or intake of an investigational drug within a period of 5 half lives of that drug prior to the screening visit

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: AZD6280; oral; Drug: Midazolam; oral; Drug: Caffeine; oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine the effects of repeated doses of AZD6280 on the pharmacokinetic profile of a CYP3A4 substrate (midazolam and its 1' hydroxy metabolite) and a CYP1A2 substrate (caffeine and its paraxanthine [3-desmethyl] metabolite).	Blood samples will be taken throughout the 19-day inpatient period of the study.

Secondary Outcome Measures

Outcome Measure	Time Frame
To evaluate the safety and tolerability of repeated doses of AZD6280 in combination with midazolam and caffeine.	Observations taken post dosing.
Evaluation of the pharmacodynamic effects of AZD6280	Test batteries will be performed before and following study drug administration.
To evaluate the pharmacokinetics of AZD6280	Blood samples will be taken throughout the 19-day inpatient period of the study.

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Darren Wilbraham, MBBS, DCPSA, Guy's Drug Research Unit Quintiles Ltd

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: January 13, 2009
• First Submitted That Met QC Criteria: January 15, 2009
• First Posted (Estimate): January 16, 2009

Study Record Updates

• Last Update Posted (Estimate): July 31, 2009
• Last Update Submitted That Met QC Criteria: July 30, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: Phase I
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Purinergic Antagonists; Purinergic Agents; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Central Nervous System Stimulants; Midazolam; Caffeine
• Other Study ID Numbers: D0850C00015