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

Phase 1CompletedNCT01330758

AstraZeneca26 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

AZD8931DRUG

40 mg AZD8931 wet granulation tablet formulation

AZD8931DRUG

40 mg AZD8931 roller compacted tablet formulation

Eligibility

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

Medical Language ↔ Plain English

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

Locations (1)

Research Site

London, United Kingdom

Outcomes

Primary Outcomes

To determine the relative bioavailability of 40 mg AZD8931 Phase II wet granulation tablet formulation in relation to the 40mg AZD8931 Phase II/III roller compacted tablet formulation.

Time frame: Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period

Secondary Outcomes

To further investigate the safety and tolerability variables (adverse events,vital signs, ECG, physical examination, safety labs).

Time frame: From screening period through to 5 to 10 days after visit 3. An average time of 7 weeks.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.