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

Drug Interaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01254461
• Other study ID #: D9830C00016
• Secondary ID: 2010-023876-14
• Status: Completed
• Phase: Phase 1
• First received: December 3, 2010
• Last updated: April 28, 2011
• Start date: February 2011
• Est. completion date: April 2011

Study information

• Verified date: April 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Drug Interaction

Intervention

Drug:
• AZD1981
100 mg per oral, twice daily for 8 days
• AZD1981
4x100 mg per oral, twice daily for 8 days
• pravastatin
40 mg, once daily at Day 1, period A and Day 8, period B

Locations

Country	Name	City	State
Sweden	Research Site	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	AUC	Pharmacokinetics for pravastatin measured by AUC[0-t],Cmax (tmax), CL/F, t1/2?z, Vz/F, MRT	PK sampling will be performed on Day 1, period A and on Day 7-8, period B	No
Secondary	AUCt	Pharmacokinetics for AZD1981 measured by AUCt,Css,max, Css, max (tmax ss), CLss/F, t1/2?z, Vz/F, MRT	PK sampling will be performed on Day 7 and Day 8, period B	No
Secondary	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	Yes