Determine the Effect of Multiple Doses of AZD7325, CYP Study (CYP)

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)

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).

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: AZD7325; Drug: Midazolam; Drug: Caffeine

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: QUADRUPLE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1	Drug: AZD7325; Oral, day 1-12; Drug: Midazolam; single dose, twice during treatment; Drug: Caffeine; single dose, twice during treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Darren Wilbraham, MBBS, DCPSA, Guy's Drug Research Unit Quintiles

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (ACTUAL): September 1, 2008
• Study Completion (ACTUAL): September 1, 2008

Study Registration Dates

• First Submitted: November 11, 2008
• First Submitted That Met QC Criteria: November 12, 2008
• First Posted (ESTIMATE): November 13, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): November 13, 2008
• Last Update Submitted That Met QC Criteria: November 12, 2008
• Last Verified: November 1, 2008

More Information

Terms related to this study

• Keywords: Phase I
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Purinergic Antagonists; Purinergic Agents; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Central Nervous System Stimulants; Midazolam; Caffeine
• Other Study ID Numbers: D1140C00005