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Trial record 86 of 88 for:    ASPIRIN AND thromboxane

Effects of Steady State Tipranavir/Ritonavir or Darunavir/Ritonavir or Ritonavir on Platelet Function, Coagulation and Fibrinolysis Biomarkers in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02251795
Recruitment Status : Completed
First Posted : September 29, 2014
Last Update Posted : September 29, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE September 25, 2014
First Posted Date  ICMJE September 29, 2014
Last Update Posted Date September 29, 2014
Study Start Date  ICMJE August 2007
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2014)
Percent change from baseline in the area under the curve (AUC) of platelet aggregation in response to arachidonic acid (AA) [ Time Frame: pre-dose, up to 48 h after drug administration ]
calculated as the ratio of the AUC at steady state TPV plasma concentrations and the baseline AUC
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2014)
  • Changes in platelet aggregation in response to AA [ Time Frame: pre-dose, up to 48 h after drug administration ]
  • Changes in platelet aggregation in response to collagen [ Time Frame: pre-dose, up to 48 h after drug administration ]
  • Changes in platelet aggregation in response adenosine diphosphate (ADP) [ Time Frame: pre-dose, up to 48 h after drug administration ]
  • Changes in closure Time (CT) [ Time Frame: pre-dose, up to 48 h after drug administration ]
    Platelet Function Analyzer (PFA)-100 test
  • Changes in urinary thromboxane B2 metabolites [ Time Frame: pre-dose, up to 48 h after drug administration ]
  • Changes in bleeding time [ Time Frame: Baseline, up to day 30 ]
  • Changes in activated partial thromboplastin time (aPTT) [ Time Frame: Baseline, up to day 30 ]
  • Changes in prothrombin time (PT) [ Time Frame: Baseline, up to day 30 ]
  • Changes in fibrinogen [ Time Frame: Baseline, up to day 30 ]
  • Changes in von Willebrand antigen [ Time Frame: Baseline, up to day 30 ]
  • Changes in von anti-thrombin III antigen [ Time Frame: Baseline, up to day 30 ]
  • Changes in anti-thrombin III activity [ Time Frame: Baseline, up to day 30 ]
  • Changes in factor II [ Time Frame: Baseline, up to day 30 ]
  • Changes in factor VII [ Time Frame: Baseline, up to day 30 ]
  • Changes in factor IX [ Time Frame: Baseline, up to day 30 ]
  • Changes in factor X [ Time Frame: Baseline, up to day 30 ]
  • Changes in plasminogen activity [ Time Frame: Baseline, up to day 30 ]
  • Changes in alpha 2-antiplasmin [ Time Frame: Baseline, up to day 30 ]
  • Changes in D-dimer [ Time Frame: Baseline, up to day 30 ]
  • Changes in Plasminogen Activator Inhibitor (PAI-1) [ Time Frame: Baseline, up to day 30 ]
  • Maximum measured concentration of the analyte in plasma (Cmax) [ Time Frame: pre-dose, up to 48 h after drug administration ]
  • Serum concentration at 12 hours (Cp12h) [ Time Frame: 12 hours after drug administration ]
  • Area under the curve from 0-12 hours (AUC0-12h) [ Time Frame: up to 12 hours after drug administration ]
  • Time from dosing to the maximum measured concentration of the analyte in plasma (Tmax) [ Time Frame: up to 48 h after drug administration ]
  • Total clearance of the analyte in plasma (CL/F) [ Time Frame: pre-dose, up to 48 h after drug administration ]
  • Apparent volume of distribution (V/F) [ Time Frame: pre-dose, up to 48 h after drug administration ]
  • Terminal half-life (t1/2) [ Time Frame: pre-dose, up to 48 h after drug administration ]
  • Number of subjects with abnormal findings in laboratory tests [ Time Frame: up to day 61 ]
  • Number of subjects with treatment-emergent adverse events [ Time Frame: up to 96 days ]
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 Effects of Steady State Tipranavir/Ritonavir or Darunavir/Ritonavir or Ritonavir on Platelet Function, Coagulation and Fibrinolysis Biomarkers in Healthy Subjects
Official Title  ICMJE Effects of Steady State Tipranavir/Ritonavir or Darunavir/Ritonavir or Ritonavir on Platelet Function, Coagulation and Fibrinolysis Biomarkers in Healthy Subjects
Brief Summary Study to determine the effect of steady-state plasma concentration of Tipranavir/ritonavir (TPV/r) on platelet aggregation in healthy subjects and investigate the effect of TPV/r at steady state plasma concentrations on other platelet functions and biomarkers of coagulation and fibrinolysis.
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: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Tipranavir
    Other Name: APTIVUS®
  • Drug: Ritonavir
    Other Name: Norvir®
  • Drug: Darunavir
    Other Name: PREZISTA®
  • Drug: Aspirin
    single dose on day 2
    Other Name: Acetylsalicylic acid
Study Arms  ICMJE
  • Experimental: Tipranavir/Ritonavir
    500 mg Tipranavir / 200 mg Ritonavir 10 days BID
    Interventions:
    • Drug: Tipranavir
    • Drug: Ritonavir
    • Drug: Aspirin
  • Active Comparator: Darunavir/Ritonavir
    600 mg Darunavir /100 mg Ritonavir 10 days BID
    Interventions:
    • Drug: Ritonavir
    • Drug: Darunavir
    • Drug: Aspirin
  • Active Comparator: Ritonavir
    100 mg Ritonavir 10 days BID
    Interventions:
    • Drug: Ritonavir
    • Drug: Aspirin
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
Actual Enrollment  ICMJE
 (submitted: September 25, 2014)
52
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Ability and willingness to give written informed consent to participate in this study (i.e., prior to any study-specific procedures)
  2. Age ≥18 years and ≤50 years
  3. Female subjects of child-bearing potential were eligible if:

    • They had used a barrier contraceptive method for at least 12 weeks before administration of study medication and had a negative serum pregnancy test result during the screening period (Day - 35 to Day -3); or,
    • Were abstinent for more than 12 weeks before screening and had a negative serum pregnancy test result during the screening period (Day -35 to Day -3); or,
    • Had a documented tubal ligation and had a negative serum pregnancy test result during the screening period (Day -35 to Day -3)
  4. Ability to swallow capsules without difficulty
  5. Reasonable probability of completing the study
  6. Findings from medical history, physical examination and 12-lead ECG indicating subject was healthy and suitable for the trial in the opinion of the investigator
  7. Agreement to abstain from alcohol consumption or drugs of abuse during the study
  8. Agreement to abstain from ingestion of grapefruit, grapefruit juice, Seville oranges, or orange marmalade from screening period to the end of the study
  9. Negative urine drug screen for drugs of abuse
  10. Non smoker
  11. Agreement to abstain from use of tobacco products from screening period to the end of the study
  12. Negative HIV-1 serology by ELISA testing
  13. Negative Hepatitis B surface Antigen test (HBsAg)
  14. Negative Hepatitis C Virus antibody (anti-HCV) test by Enzyme Immunoassay
  15. Platelet count ≥125,000/mm3
  16. Hemoglobin ≥11.0 g/dL
  17. Prothrombin time ≤1.0 x upper limit of normal (ULN)
  18. Activated Partial thromboplastin time ≤1.0 x ULN

Exclusion Criteria:

  1. Female subjects who:

    • had a positive serum pregnancy test during the screening period (Day -35 to Day -3) or during the study
    • were breast feeding or planing to breast feed at any time from the screening period through 30 days after the last dose of the study drug
    • were not willing to use a barrier method of contraception at any time from screening period through 30 days after the last dose of the study drug
    • were taking any hormonal therapy for any reason such as birth control or replacement therapy
  2. Had used any investigational agent within 30 days prior to Visit 2
  3. Blood or plasma donations (>100 mL total) for research or altruistic reasons within 30 days prior to Visit 2
  4. Had used aspirin or any non-steroidal anti-inflammatory agent (NSAID), and including COX-2 inhibitors, dipyridamole, clopidogrel, ticlopidine or other antiplatelet drugs within 14 days prior to Visit 2 or during the study
  5. Active peptic ulceration or history of peptic ulcer disease
  6. Known history of or suspected hypersensitivity to aspirin, any NSAID or any other component of the test drugs (Tipranavir, Darunavir, Ritonavir)
  7. Known hypersensitivity to antiretroviral drugs (marketed or experimental drug in clinical research studies)
  8. Active bleeding disorder or history of active bleeding disorder
  9. Active Intra cranial hemorrhage (ICH) or history of ICH
  10. Active coronary artery disease or history of coronary artery disease
  11. Alcohol abuse (more than 60 g/day)
  12. Any indication for current use of aspirin or any NSAID or indication for such use from Visit 2 to Visit 18
  13. Had used any over-the-counter medication within 7 days prior to Visit 2, or current use of any prescription drug
  14. Subjects who had an abnormal laboratory result of Grade 1 or greater, as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS), (result must have been available at least 3 days prior to Visit 2-Day 1), except the following screening laboratory values:

    • serum potassium, serum sodium, serum phosphate and uric acid, where central laboratory reference ranges will be used to determine eligibility rather than DAIDS table; or,
    • amylase or creatinine results of Grade 1 on DAIDS table if these results are considered clinically not significant by investigator; or
    • other marginally abnormal laboratory values not considered clinically significant by investigator and approved by clinical monitor
  15. History of any illness that in the opinion of the investigator might confound the results of the study or pose additional risks in administering aspirin, Tipranavir, Darunavir, or Ritonavir
  16. Hypersensitivity to sulphonamide drugs
  17. Had used proton pump inhibitors during 14 days prior to Visit 2
  18. Vitamin E intake in excess of 60 mg/day within 30 days prior to Visit 2
  19. Vitamin E supplementation in excess of 60 mg/day during the study (Vitamin E content of multivitamin tablets is allowed)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02251795
Other Study ID Numbers  ICMJE 1182.117
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Boehringer Ingelheim
Verification Date September 2014

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