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

Phase 1

Completed

• Conditions: Drug Interaction
• Interventions: Drug: AZD1981; Drug: pravastatin

• Registration Number: NCT01254461
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-12-03
• Study First Submitted QC: 2010-12-03
• Study First Posted: 2010-12-06
• Study Start: 2011-02
• Status Verified: 2011-04
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Last Update Submitted: 2011-04-28
• Last Update Posted: 2011-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	AZD1981	-
A	pravastatin	-
B	pravastatin	-
A	AZD1981	-

Primary Outcome Measures

Name	Time	Method
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	Pharmacokinetics for pravastatin measured by Cmax and AUC

Secondary Outcome Measures

Name	Time	Method
AUC	PK sampling will be performed on Day 1, period A and on Day 7-8, period B	Pharmacokinetics for pravastatin measured by AUC\[0-t\],Cmax (tmax), CL/F, t1/2λz, Vz/F, MRT
AUCτ	PK sampling will be performed on Day 7 and Day 8, period B	Pharmacokinetics for AZD1981 measured by AUCτ,Css,max, Css, max (tmax ss), CLss/F, t1/2λz, Vz/F, MRT
Safety and tolerability	Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study	Safety and tolerability of AZD1981

Trial Locations

Locations (1)

Research Site; 🇸🇪 Uppsala, Sweden