NCT00790114

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).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2008

Shorter than P25 for phase_1

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
2 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
2 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 13, 2008

Completed
Last Updated

November 13, 2008

Status Verified

November 1, 2008

Enrollment Period

2 months

First QC Date

November 11, 2008

Last Update Submit

November 12, 2008

Conditions

Healthy Volunteer

Keywords

Phase I

Outcome Measures

Primary Outcomes (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).

    Blood samples will be taken during the study.

Secondary Outcomes (3)

  • To evaluate the safety and tolerability of repeated doses of AZD7325 in combination with midazolam and caffeine.

    Blood samples will be taken during the study.

  • Evaluation of the pharmacodynamic effects of AZD7325

    Test batteries will be performed at specified times both before and following study drug administration.

  • To evaluate the pharmacokinetics of AZD7325

    Blood samples will be taken on Days 1, 11 and 12.

Study Arms (1)

1

EXPERIMENTAL
Drug: AZD7325Drug: MidazolamDrug: Caffeine

Interventions

AZD7325DRUG

Oral, day 1-12

1
MidazolamDRUG

single dose, twice during treatment

1
CaffeineDRUG

single dose, twice during treatment

1

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

4-amino-8-(2-fluoro-6-methoxy-phenyl)-N-propylcinnoline-3-carboxamideMidazolamCaffeine

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsXanthinesAlkaloidsPurinonesPurines

Study Officials

  • Darren Wilbraham, MBBS, DCPSA

    Guy's Drug Research Unit Quintiles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 11, 2008

First Posted

November 13, 2008

Study Start

July 1, 2008

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

November 13, 2008

Record last verified: 2008-11