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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Drug Interaction

Treatments: Drug: pravastatin; Drug: AZD1981

Study type: Interventional

Funder types: Industry

Identifiers

NCT01254461

2010-023876-14 (EudraCT Number)

D9830C00016

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

A

Experimental group

Treatment:

Drug: AZD1981

Drug: pravastatin

Drug: AZD1981

B

Experimental group

Treatment:

Drug: AZD1981

Drug: pravastatin

Drug: AZD1981