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Determine the Effect of Multiple Doses of AZD7325, CYP Study (CYP)

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ClinicalTrials.gov Identifier: NCT00790114
Recruitment Status : Completed
First Posted : November 13, 2008
Last Update Posted : November 13, 2008
Sponsor:
Information provided by:
AstraZeneca

Study Description
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Brief Summary:
To determine the effects of repeated doses of AZD7325 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).

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: AZD7325 Drug: Midazolam Drug: Caffeine Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: A Phase I Open-Labeled, Fixed Sequence Study to Determine the Effect of Multiple Doses of AZD7325 on the Pharmacokinetics of Midazolam (CYP3A4) and Caffeine (CYP1A2)
Study Start Date : July 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine
Drug Information available for: Midazolam

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: AZD7325
Oral, day 1-12

Drug: Midazolam
single dose, twice during treatment

Drug: Caffeine
single dose, twice during treatment


Outcome Measures
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Primary Outcome Measures :
  1. To determine the effects of repeated doses of AZD7325 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 during the study. ]

Secondary Outcome Measures :
  1. To evaluate the safety and tolerability of repeated doses of AZD7325 in combination with midazolam and caffeine. [ Time Frame: Blood samples will be taken during the study. ]
  2. Evaluation of the pharmacodynamic effects of AZD7325 [ Time Frame: Test batteries will be performed at specified times both before and following study drug administration. ]
  3. To evaluate the pharmacokinetics of AZD7325 [ Time Frame: Blood samples will be taken on Days 1, 11 and 12. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00790114


Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Darren Wilbraham, MBBS, DCPSA Guy's Drug Research Unit Quintiles
More Information
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Responsible Party: Mark A. Smith, MD, PhDMedical Science Sr.Director, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00790114    
Other Study ID Numbers: D1140C00005
First Posted: November 13, 2008    Key Record Dates
Last Update Posted: November 13, 2008
Last Verified: November 2008
Keywords provided by AstraZeneca:
Phase I
Additional relevant MeSH terms:
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Midazolam
Caffeine
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
 Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents