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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01254461
First Posted: December 6, 2010
Last Update Posted: April 29, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
The primary purpose of this study is to determine whether the treatment with AZD1981 will affect the pharmacokinetics of pravastatin.

Condition Intervention Phase
Drug Interaction Drug: AZD1981 Drug: pravastatin Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • AUC [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study ]
    Safety and tolerability of AZD1981


Estimated Enrollment: 30
Study Start Date: February 2011
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: AZD1981
100 mg per oral, twice daily for 8 days
Drug: pravastatin
40 mg, once daily at Day 1, period A and Day 8, period B
Other Name: pravachol
Experimental: B Drug: AZD1981
4x100 mg per oral, twice daily for 8 days
Drug: pravastatin
40 mg, once daily at Day 1, period A and Day 8, period B
Other Name: pravachol

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01254461


Locations
Sweden
Research Site
Uppsala, Sweden
Sponsors and Collaborators
AstraZeneca
  More Information

Responsible Party: Christer Hultquist/Medical Science Director, AstraZeneca R&D
ClinicalTrials.gov Identifier: NCT01254461     History of Changes
Other Study ID Numbers: D9830C00016
2010-023876-14 ( EudraCT Number )
First Submitted: December 3, 2010
First Posted: December 6, 2010
Last Update Posted: April 29, 2011
Last Verified: April 2011

Keywords provided by AstraZeneca:
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

Additional relevant MeSH terms:
Pravastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors