Determine the Effect of Multiple Doses of AZD7325, CYP Study - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00790114

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 I

MedlinePlus related topics: Caffeine

Drug Information available for: Midazolam Midazolam hydrochloride Midazolam maleate 3,7-Dihydro-1,3,7-trimethyl-1H-purine-2,6-dione Caffeine citrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Single Group Assignment, Safety Study
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)

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
1: Experimental	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

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

Responsible Party:	AstraZeneca Pharmaceuticals ( Mark A. Smith, MD, PhDMedical Science Sr.Director )
Study ID Numbers:	D1140C00005
Study First Received:	November 11, 2008
Last Updated:	November 12, 2008
ClinicalTrials.gov Identifier:	NCT00790114
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; United Kingdom: Research Ethics Committee

Keywords provided by AstraZeneca:

Phase I

Study placed in the following topic categories:

Caffeine citrate
Caffeine
Healthy
Midazolam

Additional relevant MeSH terms:

Anesthetics, Intravenous
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Anesthetics
Central Nervous System Depressants
Enzyme Inhibitors

Central Nervous System Stimulants
Pharmacologic Actions
Adjuvants, Anesthesia
Phosphodiesterase Inhibitors
Anesthetics, General
Therapeutic Uses
Hypnotics and Sedatives
GABA Agents
Anti-Anxiety Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009