NCT00824057

Brief Summary

The aim of this study is to investigate the effects of taking repeated doses of AZD6280 on the blood levels of midazolam and caffeine in healthy volunteers

Trial Health

87
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 healthy

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_1 healthy

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 16, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

July 31, 2009

Status Verified

July 1, 2009

First QC Date

January 13, 2009

Last Update Submit

July 30, 2009

Conditions

Healthy

Keywords

Phase I

Outcome Measures

Primary Outcomes (1)

  • To determine the effects of repeated doses of AZD6280 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 throughout the 19-day inpatient period of the study.

Secondary Outcomes (3)

  • To evaluate the safety and tolerability of repeated doses of AZD6280 in combination with midazolam and caffeine.

    Observations taken post dosing.

  • Evaluation of the pharmacodynamic effects of AZD6280

    Test batteries will be performed before and following study drug administration.

  • To evaluate the pharmacokinetics of AZD6280

    Blood samples will be taken throughout the 19-day inpatient period of the study.

Study Arms (1)

1

EXPERIMENTAL
Drug: AZD6280Drug: MidazolamDrug: Caffeine

Interventions

AZD6280DRUG

oral

1
MidazolamDRUG

oral

1
CaffeineDRUG

oral

1

Eligibility Criteria

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

You may qualify if:

  • Healthy male subjects aged 18 to 45 years (inclusive) on Day 1.

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

Study Sites (1)

Research Site

London, United Kingdom

Location

MeSH Terms

Interventions

4-amino-8-(2,5-dimethoxyphenyl)-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 Ltd

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 13, 2009

First Posted

January 16, 2009

Study Start

January 1, 2009

Study Completion

March 1, 2009

Last Updated

July 31, 2009

Record last verified: 2009-07

Locations

GB(1)