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Completed

NCT Number: NCT00824057

Effect of Multiple Doses of AZD6280 on the Pharmacokinetics of Midazolam (CYP3A4) and Caffeine (CYP1A2)

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

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

AZD6280

Drug

oral

midazolam

Drug

oral

Caffeine

Drug

oral

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).

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

Secondary outcomes

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

    Time frame: Observations taken post dosing.

  2. Evaluation of the pharmacodynamic effects of AZD6280

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

  3. To evaluate the pharmacokinetics of AZD6280

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase I Open-labeled, Fixed Sequence Study to Determine the Effect of Multiple Doses of AZD6280 on the Pharmacokinetics of Midazolam (CYP3A4) and Caffeine (CYP1A2)

Acronym: CYP

Important dates

Study start
2009
Study completion
2009
First posted
Jan 16, 2009
Registry last updated
Jul 31, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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