Determine the Effect of Multiple Doses of AZD7325, CYP Study

AstraZeneca24 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

QUADRUPLE

Enrollment

Conditions

Healthy Volunteer

Interventions

AZD7325DRUG

Oral, day 1-12

MidazolamDRUG

single dose, twice during treatment

CaffeineDRUG

single dose, twice during treatment

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.

Evaluation of the pharmacodynamic effects of AZD7325

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

To evaluate the pharmacokinetics of AZD7325

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

Data from ClinicalTrials.gov

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