NCT00692510

Brief Summary

The purpose of the study is to evaluate if AZD3480 inhibits Cytochrome P450 1A2, 2C19, 3A4, 2C8, 2B6 and UGT1A1 activity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 6, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

November 26, 2008

Status Verified

November 1, 2008

Enrollment Period

10 months

First QC Date

May 29, 2008

Last Update Submit

November 25, 2008

Conditions

MetabolismAlzheimer's Disease

Keywords

AZD3480CocktailcaffeinebupropionomeprazolemidazolamrosiglitazonemetabolismDrug Drug Interaction

Outcome Measures

Primary Outcomes (1)

  • PK variables

    Frequent sampling occasions during the treatment periods

Secondary Outcomes (1)

  • Safety variables (adverse events, blood pressure, pulse, safety lab)

    During the whole treatment period

Study Arms (2)

1

EXPERIMENTAL

AZD3480 + cocktail

Drug: AZD3480Drug: Cocktail mix (Caffeine, Bupropion, Rosiglitazone, Omeprazole, Midazolam, Bilirubin)

2

PLACEBO COMPARATOR

Placebo + cocktail

Drug: PlaceboDrug: Cocktail mix (Caffeine, Bupropion, Rosiglitazone, Omeprazole, Midazolam, Bilirubin)

Interventions

AZD3480DRUG

Capsule, oral, dose once daily, 7 days

1
PlaceboDRUG

Capsule, oral, dose once daily, 7 days

2
Cocktail mix (Caffeine, Bupropion, Rosiglitazone, Omeprazole, Midazolam, Bilirubin)DRUG

Cocktail mix which contains the following: CYP1A2 (Caffeine), CYP2B6 (Bupropion), CYP2C8 (Rosiglitazone), CYP2C19 (Omeprazole), CYP3A4 (Midazolam), UGT1A1 (Bilirubin) single dose of mix

12

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Provision of signed written informed consent
  • Clinically normal physical findings and laboratory values

You may not qualify if:

  • Clinically significant illness or clinically relevant trauma within three weeks before the first dose
  • History of clinically significant disease
  • Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Uppsala, Sweden

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

isproniclineCaffeineBupropionRosiglitazoneOmeprazoleMidazolamBilirubin

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPropiophenonesKetonesOrganic ChemicalsThiazolidinedionesThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-Ring2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesPyridinesBenzimidazolesBenzodiazepinesBenzazepinesBile PigmentsTetrapyrrolesPyrrolesHeterocyclic Compounds, 4 or More RingsMacrocyclic CompoundsPolycyclic CompoundsPigments, BiologicalBiological Factors

Study Officials

  • Hans-Göran Hårdemark, MD

    AstraZeneca R&D, Södertälje, Sweden

    STUDY DIRECTOR

  • Cyril Clarke, MD

    ICON Development Solutions Manchester, Manchester Science Park, Manchester, UK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 29, 2008

First Posted

June 6, 2008

Study Start

November 1, 2007

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

November 26, 2008

Record last verified: 2008-11

Locations

SE(1)