Determine the Effect of Multiple Doses of AZD7325, CYP Study

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: Caffeine; Drug: Midazolam; Drug: AZD7325

Study type: Interventional

Funder types: Industry

Identifiers

NCT00790114

D1140C00005

Details and patient eligibility

About

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).

Enrollment: 24 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

24 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Caffeine

Drug: Midazolam

Drug: AZD7325