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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: AZD8931

• Registration Number: NCT01330758
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-22
• Study Start: 2011-04
• Study First Submitted QC: 2011-04-06
• Study First Posted: 2011-04-07
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-28
• Last Update Posted: 2011-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
40 mg AZD8931 roller compacted tablet formulation	AZD8931	-
40 mg AZD8931 wet granulation tablet formulation	AZD8931	-

Primary Outcome Measures

Name	Time	Method
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.	Pharmacokinetic (PK) sampling will be performed day 1 to day 5 for each treatment period

Secondary Outcome Measures

Name	Time	Method
To further investigate the safety and tolerability variables (adverse events,vital signs, ECG, physical examination, safety labs).	From screening period through to 5 to 10 days after visit 3. An average time of 7 weeks.

Trial Locations

Locations (1)

Research Site; 🇬🇧 London, United Kingdom