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OpenTrials
Completed

NCT Number: NCT00790114

Determine the Effect of Multiple Doses of AZD7325, CYP Study

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).

Completed

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Key information

Conditions

Healthy Volunteer

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

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

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

AZD7325

Drug

Oral, day 1-12

midazolam

Drug

single dose, twice during treatment

Caffeine

Drug

single dose, twice during treatment

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).

    Time frame: Blood samples will be taken during the study.

Secondary outcomes

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

    Time frame: Blood samples will be taken during the study.

  2. Evaluation of the pharmacodynamic effects of AZD7325

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

  3. To evaluate the pharmacokinetics of AZD7325

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

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 AZD7325 on the Pharmacokinetics of Midazolam (CYP3A4) and Caffeine (CYP1A2)

Acronym: CYP

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Nov 13, 2008
Registry last updated
Nov 13, 2008

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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