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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: AZD8931

Study type: Interventional

Funder types: Industry

Identifiers

NCT00879346

D0102C00011

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

24 participants in 1 patient group

1

Experimental group

Description:

160mg oral dose of AZD8931

Treatment:

Drug: AZD8931