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

AstraZeneca1 site in 1 country30 target enrollmentFebruary 2011

Overview

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

Registry

clinicaltrials.gov

Start Date

February 2011

End Date

April 2011

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Sponsor

•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

Intervention: AZD1981

Intervention: pravastatin

Intervention: AZD1981

Intervention: pravastatin

Pharmacokinetics for pravastatin measured by Cmax and AUC

Time Frame: 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

AUC(PK sampling will be performed on Day 1, period A and on Day 7-8, period B)
AUCτ(PK sampling will be performed on Day 7 and Day 8, period B)
Safety and tolerability(Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study)