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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01330758

Enrollment

Registered

2011-04-07

Start date

2011-04-30

Completion date

2011-05-31

Last updated

2011-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

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

Brief summary

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

Interventions

DRUGAZD8931

40 mg AZD8931 wet granulation tablet formulation

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026