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

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.
 
ClinicalTrials.gov Identifier: NCT01254461
Recruitment Status : Completed
First Posted : December 6, 2010
Last Update Posted : April 29, 2011
Sponsor:
Information provided by:
AstraZeneca

Tracking Information
First Submitted Date  ICMJE December 3, 2010
First Posted Date  ICMJE December 6, 2010
Last Update Posted Date April 29, 2011
Study Start Date  ICMJE February 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 2, 2011)
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
Original Primary Outcome Measures  ICMJE
 (submitted: December 3, 2010)
Cmax and 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 Maximum Concentration (Cmax) and Area Under the Curve (AUC)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2010)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Drug-Drug Interaction Study Between AZD1981 and Pravastatin to Study the Effect of AZD1981 on the Kinetics of Pravastatin
Official Title  ICMJE 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
Brief Summary The primary purpose of this study is to determine whether the treatment with AZD1981 will affect the pharmacokinetics of pravastatin.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Drug Interaction
Intervention  ICMJE
  • Drug: AZD1981
    100 mg per oral, twice daily for 8 days
  • 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
Study Arms  ICMJE
  • Experimental: A
    Interventions:
    • Drug: AZD1981
    • Drug: pravastatin
  • Experimental: B
    Interventions:
    • Drug: AZD1981
    • Drug: pravastatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: December 3, 2010)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01254461
Other Study ID Numbers  ICMJE D9830C00016
2010-023876-14 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Christer Hultquist/Medical Science Director, AstraZeneca R&D
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account AstraZeneca
Verification Date April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP