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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01254461

Enrollment

Registered

2010-12-06

Start date

2011-02-28

Completion date

2011-04-30

Last updated

2011-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Interaction

Keywords

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

Brief summary

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

Interventions

DRUGAZD1981

100 mg per oral, twice daily for 8 days

DRUGpravastatin

40 mg, once daily at Day 1, period A and Day 8, period B

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026