A Drug-Drug Interaction Study Between AZD1981 and Pravastatin to Study the Effect of AZD1981 on the Kinetics of Pravastatin

Study Overview
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Brief Summary
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The primary purpose of this study is to determine whether the treatment with AZD1981 will affect the pharmacokinetics of pravastatin.

Official Title
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A Phase I, Open Label, Randomised, Parallel Group Study of Repeated Oral Doses of AZD1981 (100 mg Twice Daily and 400 mg Twice Daily Via Tablet) for Eight Days and Single Doses of Pravastatin (Pravachol® Tablet 40 mg) to Evaluate the Pharmacokinetic Interaction of AZD1981 and Pravastatin in Healthy Male Volunteers

Conditions
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Drug Interaction

Intervention / Treatment
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* Drug: AZD1981
* Drug: AZD1981
* Drug: pravastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male volunteers aged 18 to 55, inclusive Have a body mass index between 19 and 30 kg/m2 and weight 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 contraception during study and 3 months after the end of their participation in the study Exclusion Criteria: Any clinically significant disease or disorder Any clinically relevant abnormal findings in physical examination

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

Sexes Eligible for Study
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Male

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: AZD1981<br>* 100 mg per oral, twice daily for 8 days<br>Drug: pravastatin<br>* 40 mg, once daily at Day 1, period A and Day 8, period B<br>* Other names: pravachol;|
| Experimental: B<br> | Drug: AZD1981<br>* 4x100 mg per oral, twice daily for 8 days<br>Drug: pravastatin<br>* 40 mg, once daily at Day 1, period A and Day 8, period B<br>* Other names: pravachol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics for pravastatin measured by Cmax and AUC | Pharmacokinetics for pravastatin measured by Cmax and AUC | Pharmacokinetic (PK) sampling will be performed on Day 1, period A and on Day 7-8, period B | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC | Pharmacokinetics for pravastatin measured by AUC[0-t],Cmax (tmax), CL/F, t1/2λz, Vz/F, MRT | PK sampling will be performed on Day 1, period A and on Day 7-8, period B | 
| AUCτ | Pharmacokinetics for AZD1981 measured by AUCτ,Css,max, Css, max (tmax ss), CLss/F, t1/2λz, Vz/F, MRT | PK sampling will be performed on Day 7 and Day 8, period B | 
| Safety and tolerability | Safety and tolerability of AZD1981 | Safety will be monitored continously 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, Drug-Drug interaction, pravastatin, AZD1981, The pharmacokinetics resulting from AZD1981 and pravastatin interaction, The effects of taking a combination of AZD1981 and pravastatin