A Bioavailability Study Comparing 3 Different AZD1981 Tablets

Study Overview
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Brief Summary
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The purpose of this study is to study the relative bioavailability of AZD1981 when using a new tablet compared to the current tablet.

Official Title
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A Phase I, Open Label, Randomised, 4-way Crossover Study to Investigate the Relative Bioavailability of Single Dose AZD1981 Via 3 Different Tablets in Healthy Men and Healthy Women of Non-childbearing Potential

Conditions
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Healthy

Intervention / Treatment
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* Drug: AZD1981, current small-particle tablet
* Drug: AZD1981, new small-particle tablet
* Drug: AZD1981, new large-particle table


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and postmenopausal or surgically sterile female volunteers aged 18-55, inclusive Have a body mass index between 19-30 kg/m2 and weigh at least 50 kg and no more than 100 kg, inclusive Be a non-smoker or ex-smoker who has stopped smoking for >6 months prior to screening Volunteers must be willing to use barrier methods of contraceptive, unless their partners are post-menopausal, surgically sterile or using accepted contraceptive methods. Exclusion Criteria: Any clinically significant disease or disorder Any clinically relevant abnormal findings in the physical examination, clinical chemistry, haematology, urinalysis, vital signs (including body temperature), or ECG assessments at Visit 1, or in vital signs (including body temperature) at Visit 2 Prolonged QTcF >450 ms or shortened QTcF<340 ms at Visit 1 or family history of long QT syndrome History of, or current alcohol or drug abuse

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

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br> | Drug: AZD1981, current small-particle tablet<br>* 3x100 mg per oral, single dose in fasted state<br>|
| Experimental: Treatment B<br> | Drug: AZD1981, new small-particle tablet<br>* 3x100 mg per oral, single dose<br>|
| Experimental: Treatment C<br> | Drug: AZD1981, new small-particle tablet<br>* 3x100 mg per oral, single dose<br>|
| Experimental: Treatment D<br> | Drug: AZD1981, new large-particle table<br>* 3x100 mg per oral, single dose in fasted state<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the area under the plasma concentration time-curve from zero to infinity /AUC) and the maximum plasma concentration (Cmax) of AZD1981 |  | Pharmacokinetic (PK) sampling continuously for 60 h after each single dose, ie day 1-3 for each period. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate basic systemic PK parameters as follows: | AUC(0-t): area under the plasma concentration versus time curve from time zero to time of last quantifiable concentration tmax: time to reach Cmax t1/2λz: terminal half-life CL/F: apparent plasma clearance MRT: apparent mean residence time Vz/F: apparent volume of distribution during terminal phase | PK sampling continuously for 60 h after each single dose, ie day 1-3 for each period | 
| To evaluate the safety and tolerability of AZD1981 by assessment of adverse events, laboratory safety parameters, vital signs, ECG, physical examination and weight |  | Safety will be monitored continuously and safety assessments will be made on several occasions throughout the whole study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase 1, bioavailability study, AZD1981, tablets, To study the relative bioavailability of single dose AZD1981 via three different tablets, To compare the bioavailability between three different AZD1981 tablets