A Study to Compare Two Different Tablet Formulations of AZD8931 in Healthy Males and Females

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: AZD8931

Study type: Interventional

Funder types: Industry

Identifiers

NCT01330758

D0102C00005

Details and patient eligibility

About

A study to compare two different tablet formulations of AZD8931 in healthy males and females.

Enrollment: 26 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female subjects aged 18 to 55 years
• Females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating and must be of non-child bearing potential
• Body mass index between 19 and 30 kg/m2 and weight at least 50 kg and no more than 100 kg
• Male subjects must be willing to use barrier methods of contraception
• Be willing and able to comply with study procedures, restrictions and requirements

Exclusion criteria

• History of any clinically significant disease or disorder
• Any clinically significant abnormalities at screening
• Use of any prescribed or non-prescribed medication within 2 weeks
• Receipt of another NCE or participation in any other clinical trial within 3 months
• Subjects who have previously received AZD8931

Trial design

26 participants in 2 patient groups

40 mg AZD8931 wet granulation tablet formulation

Active Comparator group

Treatment:

Drug: AZD8931

Drug: AZD8931

40 mg AZD8931 roller compacted tablet formulation

Experimental group

Treatment:

Drug: AZD8931

Drug: AZD8931