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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00824057
First received: January 13, 2009
Last updated: July 30, 2009
Last verified: July 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy
 Drug: AZD6280
Drug: Midazolam
Drug: Caffeine
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: 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)

Resource links provided by NLM:

MedlinePlus related topics: Caffeine
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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). [ Time Frame: Blood samples will be taken throughout the 19-day inpatient period of the study. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate the safety and tolerability of repeated doses of AZD6280 in combination with midazolam and caffeine. [ Time Frame: Observations taken post dosing. ] [ Designated as safety issue: No ]
  • Evaluation of the pharmacodynamic effects of AZD6280 [ Time Frame: Test batteries will be performed before and following study drug administration. ] [ Designated as safety issue: No ]
  • To evaluate the pharmacokinetics of AZD6280 [ Time Frame: Blood samples will be taken throughout the 19-day inpatient period of the study. ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: January 2009
Study Completion Date: March 2009
Arms Assigned Interventions
Experimental: 1 Drug: AZD6280
oral
Drug: Midazolam
oral
Drug: Caffeine
oral

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00824057

Locations
United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Darren Wilbraham, MBBS, DCPSA Guy's Drug Research Unit Quintiles Ltd
  More Information

No publications provided

Responsible Party: Mark A. Smith, MD, PhDMedical Science Sr.Director, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00824057     History of Changes
Other Study ID Numbers: D0850C00015
Study First Received: January 13, 2009
Last Updated: July 30, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Keywords provided by AstraZeneca:
Phase I

Additional relevant MeSH terms:
Caffeine
Midazolam
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
 Neurotransmitter Agents
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents

ClinicalTrials.gov processed this record on May 23, 2013