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HealthyPhase 1NCT02251795

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

A Phase 1 study testing Tipranavir, Ritonavir and Darunavir in people with Healthy, run by Boehringer Ingelheim.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Tipranavir, Ritonavir and Darunavir
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
No sites listed yet
Study dates
Aug 2007to Jun 2008
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Ability and willingness to give written informed consent to participate in this study (i.e., prior to any study-specific procedures)
  • Age ≥18 years and ≤50 years
  • 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)
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  • Ability to swallow capsules without difficulty
  • Reasonable probability of completing the study
  • 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
  • Agreement to abstain from alcohol consumption or drugs of abuse during the study
  • Agreement to abstain from ingestion of grapefruit, grapefruit juice, Seville oranges, or orange marmalade from screening period to the end of the study
  • Negative urine drug screen for drugs of abuse
  • Non smoker
  • Agreement to abstain from use of tobacco products from screening period to the end of the study
  • Negative HIV-1 serology by ELISA testing
  • Negative Hepatitis B surface Antigen test (HBsAg)
  • Negative Hepatitis C Virus antibody (anti-HCV) test by Enzyme Immunoassay
  • Platelet count ≥125,000/mm3
  • Hemoglobin ≥11.0 g/dL
  • Prothrombin time ≤1.0 x upper limit of normal (ULN)
  • Activated Partial thromboplastin time ≤1.0 x ULN

Who cannot join

  • 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
  • Had used any investigational agent within 30 days prior to Visit 2
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  • Blood or plasma donations (>100 mL total) for research or altruistic reasons within 30 days prior to Visit 2
  • 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
  • Active peptic ulceration or history of peptic ulcer disease
  • Known history of or suspected hypersensitivity to aspirin, any NSAID or any other component of the test drugs (Tipranavir, Darunavir, Ritonavir)
  • Known hypersensitivity to antiretroviral drugs (marketed or experimental drug in clinical research studies)
  • Active bleeding disorder or history of active bleeding disorder
  • Active Intra cranial hemorrhage (ICH) or history of ICH
  • Active coronary artery disease or history of coronary artery disease
  • Alcohol abuse (more than 60 g/day)
  • Any indication for current use of aspirin or any NSAID or indication for such use from Visit 2 to Visit 18
  • Had used any over-the-counter medication within 7 days prior to Visit 2, or current use of any prescription drug
  • 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
  • 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
  • Hypersensitivity to sulphonamide drugs
  • Had used proton pump inhibitors during 14 days prior to Visit 2
  • Vitamin E intake in excess of 60 mg/day within 30 days prior to Visit 2
  • Vitamin E supplementation in excess of 60 mg/day during the study (Vitamin E content of multivitamin tablets is allowed)

About this study

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.

Conditions
Healthy
Being tested
Tipranavir, Ritonavir, Darunavir, Aspirin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TipranavirDrug

    Also called APTIVUS®

  • RitonavirDrug

    Also called Norvir®

  • DarunavirDrug

    Also called PREZISTA®

  • AspirinDrug

    Also called Acetylsalicylic acid

    single dose on day 2

Study groups in NCT02251795
Study groupRoleWhat they receive
Tipranavir/RitonavirExperimental500 mg Tipranavir / 200 mg Ritonavir 10 days BID
Receives: Drug: Tipranavir; Drug: Ritonavir; Drug: Aspirin
Darunavir/RitonavirActive comparator600 mg Darunavir /100 mg Ritonavir 10 days BID
Receives: Drug: Ritonavir; Drug: Darunavir; Drug: Aspirin
RitonavirActive comparator100 mg Ritonavir 10 days BID
Receives: Drug: Ritonavir; Drug: Aspirin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent change from baseline in the area under the curve (AUC) of platelet aggregation in response to arachidonic acid (AA)

    calculated as the ratio of the AUC at steady state TPV plasma concentrations and the baseline AUC

    Measured: pre-dose, up to 48 h after drug administration

Secondary outcomes (29)

  1. Changes in platelet aggregation in response to AA

    Measured: pre-dose, up to 48 h after drug administration

  2. Changes in platelet aggregation in response to collagen

    Measured: pre-dose, up to 48 h after drug administration

  3. Changes in platelet aggregation in response adenosine diphosphate (ADP)

    Measured: pre-dose, up to 48 h after drug administration

  4. Changes in closure Time (CT)

    Platelet Function Analyzer (PFA)-100 test

    Measured: pre-dose, up to 48 h after drug administration

  5. Changes in urinary thromboxane B2 metabolites

    Measured: pre-dose, up to 48 h after drug administration

  6. Changes in bleeding time

    Measured: Baseline, up to day 30

  7. Changes in activated partial thromboplastin time (aPTT)

    Measured: Baseline, up to day 30

  8. Changes in prothrombin time (PT)

    Measured: Baseline, up to day 30

  9. Changes in fibrinogen

    Measured: Baseline, up to day 30

  10. Changes in von Willebrand antigen

    Measured: Baseline, up to day 30

  11. Changes in von anti-thrombin III antigen

    Measured: Baseline, up to day 30

  12. Changes in anti-thrombin III activity

    Measured: Baseline, up to day 30

  13. Changes in factor II

    Measured: Baseline, up to day 30

  14. Changes in factor VII

    Measured: Baseline, up to day 30

  15. Changes in factor IX

    Measured: Baseline, up to day 30

  16. Changes in factor X

    Measured: Baseline, up to day 30

  17. Changes in plasminogen activity

    Measured: Baseline, up to day 30

  18. Changes in alpha 2-antiplasmin

    Measured: Baseline, up to day 30

  19. Changes in D-dimer

    Measured: Baseline, up to day 30

  20. Changes in Plasminogen Activator Inhibitor (PAI-1)

    Measured: Baseline, up to day 30

  21. Maximum measured concentration of the analyte in plasma (Cmax)

    Measured: pre-dose, up to 48 h after drug administration

  22. Serum concentration at 12 hours (Cp12h)

    Measured: 12 hours after drug administration

  23. Area under the curve from 0-12 hours (AUC0-12h)

    Measured: up to 12 hours after drug administration

  24. Time from dosing to the maximum measured concentration of the analyte in plasma (Tmax)

    Measured: up to 48 h after drug administration

  25. Total clearance of the analyte in plasma (CL/F)

    Measured: pre-dose, up to 48 h after drug administration

  26. Apparent volume of distribution (V/F)

    Measured: pre-dose, up to 48 h after drug administration

  27. Terminal half-life (t1/2)

    Measured: pre-dose, up to 48 h after drug administration

  28. Number of subjects with abnormal findings in laboratory tests

    Measured: up to day 61

  29. Number of subjects with treatment-emergent adverse events

    Measured: up to 96 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2014 (estimated)
  2. Study startAug 2007
  3. Primary completionJun 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02251795
Sponsor's protocol ID
1182.117
Status last verified
Sep 2014
First submitted
25 Sep 2014
Last updated
29 Sep 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tipranavir, Ritonavir and Darunavir in people with Healthy, run by Boehringer Ingelheim.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02251795.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2014.

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