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

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT01330758

First received: March 22, 2011

Last updated: July 28, 2011

Last verified: July 2011

Purpose

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

Condition	Intervention	Phase
Healthy	Drug: AZD8931	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Open Label
Official Title:	A Phase I, Randomised, Open-label, Cross-over, Single-centre Study in Healthy Male and Non-fertile Female Volunteers to Determine the Relative Bioavailability of the Phase II Wet Granulation Tablet Formulation Compared to the Phase II/III Roller Compacted Tablet Formulation of AZD8931

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	26
Study Start Date:	April 2011
Study Completion Date:	May 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 40 mg AZD8931 wet granulation tablet formulation	Drug: AZD8931 40 mg AZD8931 wet granulation tablet formulation
Experimental: 40 mg AZD8931 roller compacted tablet formulation	Drug: AZD8931 40 mg AZD8931 roller compacted tablet formulation

Eligibility

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01330758

Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Mary Stuart	AstraZeneca,1F64, Mereside, Alderley Park, Macclesfield, Cheshire,SK10 4TG UK
Principal Investigator:	Dr Darren Wilbraham, DICP, MBBS	Quintiles Drug Research Unit at Guy's Hospital
Study Director:	Jason Clark, BSc	Quintiles Drug Research Unit at Guy's Hospital

More Information

No publications provided

Responsible Party:	Mary Stuart/Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier:	NCT01330758 History of Changes
Other Study ID Numbers:	D0102C00005
Study First Received:	March 22, 2011
Last Updated:	July 28, 2011
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:

Phase I
Healthy male and non-fertile female volunteers
Bioavailability
AZD8931

ClinicalTrials.gov processed this record on June 17, 2013