A Study to Determine the Effect of Food on the Pharmacokinetics of Oral AZD8931 Tablets

AstraZeneca24 enrolled

Overview

Phase I, randomised, open label, 3-period crossover study in healthy male subjects to investigate the effect of food on the pharmacokinetics of AZD8931 and to investigate the safety and tolerability of AZD8931.

Study Type

INTERVENTIONAL

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

AZD8931DRUG

160mg oral single dose (4 x 40mg tablets)

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Provision of written informed consent * Body mass index (BMI) between 19 and 30 kg/m2 Exclusion Criteria: * Use of any prescribed or non-prescribed medication (including analgesics, herbal remedies, vitamins and minerals) during the two weeks prior to the first administration of investigational product * Administration of another investigational medicinal product in the 3 months before the start of dosing in this study * Definite or suspected clinically relevant personal history of adverse drug reactions, or drug hypersensitivity

Locations (1)

Research Site

Alderley Park, Cheshire, United Kingdom

Outcomes

Primary Outcomes

To investigate the effect of food on the pharmacokinetics of AZD8931 160mg oral dose

Time frame: Multiple blood PK samples taken between predose to up to 5 days post last dose

Secondary Outcomes

To evaluate the safety profile by assessment of adverse events, physical examination, pulse, blood pressure, clinical chemistry, haematology, urinalysis & ECG

Time frame: Maximus of 7 weeks (From time of consent to last visit including any follow-up)

Data from ClinicalTrials.gov

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