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Determine the Effect of Multiple Doses of AZD7325, CYP Study

NCT ID: NCT00790114

Last Updated: 2008-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2008-09-30

Brief Summary

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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).

Detailed Description

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Conditions

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Healthy Volunteer

Keywords

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Phase I

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

AZD7325

Intervention Type DRUG

Oral, day 1-12

Midazolam

Intervention Type DRUG

single dose, twice during treatment

Caffeine

Intervention Type DRUG

single dose, twice during treatment

Interventions

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AZD7325

Oral, day 1-12

Intervention Type DRUG

Midazolam

single dose, twice during treatment

Intervention Type DRUG

Caffeine

single dose, twice during treatment

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca Pharmaceuticals

Principal Investigators

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Darren Wilbraham, MBBS, DCPSA

Role: PRINCIPAL_INVESTIGATOR

Guy's Drug Research Unit Quintiles

Other Identifiers

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D1140C00005

Identifier Type: -

Identifier Source: org_study_id