Determine the Effect of Multiple Doses of AZD7325, CYP Study

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00790114
First received: November 11, 2008
Last updated: November 12, 2008
Last verified: November 2008
  Purpose

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 Intervention Phase
Healthy Volunteer
Drug: AZD7325
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)
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)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • Evaluation of the pharmacodynamic effects of AZD7325 [ Time Frame: Test batteries will be performed at specified times both before and following study drug administration. ] [ Designated as safety issue: No ]
  • To evaluate the pharmacokinetics of AZD7325 [ Time Frame: Blood samples will be taken on Days 1, 11 and 12. ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: July 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AZD7325
Oral, day 1-12
Drug: Midazolam
single dose, twice during treatment
Drug: Caffeine
single dose, twice during treatment

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00790114

Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Darren Wilbraham, MBBS, DCPSA Guy's Drug Research Unit Quintiles
  More Information

No publications provided

Responsible Party: Mark A. Smith, MD, PhDMedical Science Sr.Director, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00790114     History of Changes
Other Study ID Numbers: D1140C00005
Study First Received: November 11, 2008
Last Updated: November 12, 2008
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
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents

ClinicalTrials.gov processed this record on August 18, 2014