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

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

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: AZD8931
* Drug: AZD8931


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 40 mg AZD8931 wet granulation tablet formulation<br> | Drug: AZD8931<br>* 40 mg AZD8931 wet granulation tablet formulation<br>|
| Experimental: 40 mg AZD8931 roller compacted tablet formulation<br> | Drug: AZD8931<br>* 40 mg AZD8931 roller compacted tablet formulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase I, Healthy male and non-fertile female volunteers, Bioavailability, AZD8931