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Hepatic InsufficiencyPhase 1NCT02249442

Study to Determine the Pharmacokinetics on TPV/r in Subjects With Mild and Moderate Hepatic Insufficiency

A Phase 1 study testing Tipranavir (TPV) and Ritonavir (r) in people with Hepatic Insufficiency, 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

To determine the pharmacokinetics of single-dose and steady-state Tipranavir/Ritonavir (TPV/r) 500/200 mg in subjects with mild to moderate hepatic insufficiency Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hepatic Insufficiency
What is being tested?
Tipranavir (TPV) and Ritonavir (r)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
No sites listed yet
Study dates
1 Oct 2003to 1 Jun 2004
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent prior to trial participation.
  • Male and female subjects with:
  • Diagnostically established hepatic disease with mild hepatic insufficiency (defined as maximum ever Child-Pugh score ≤6) or
  • Diagnostically established hepatic disease with moderate hepatic insufficiency (defined as maximum ever Child-Pugh score ≤9) for less than 5 years. Current Child-Pugh score must be less than 9 or
  • Subjects matched by gender, race, age (±3 years), and weight (±3 kg) and cigarette smoking (matched where possible by +/- .25 pack years) to subjects with mild or moderate hepatic impairment already enrolled in the study.
  • Body Mass Index (BMI) between 18 and 29 kg/m2
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  • Subjects ≥18 and ≤75 years old.
  • Ability to swallow multiple large capsules without difficulty.
  • Laboratory values that indicate adequate baseline organ function are required at the time of screening. All subjects (including healthy controls) should have all laboratory values less than or equal to Grade 1, based on the AIDS Clinical Trial Group (ACTG) Grading Scale.The following exceptions will be made only for subjects with mild or moderate hepatic insufficiency:
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <5 x upper limit normal (ULN) (≤ Grade 2)
  • Alkaline Phosphatase <2 x ULN
  • Hemoglobin >10.0 g / dL
  • Platelets >75,000 / μl
  • Willingness to abstain from alcohol starting 2 days prior to administration of study drug up to the end of the study.
  • Willingness to abstain from the following 72 hours prior to pharmacokinetic (PK) sampling: Garlic supplements, methylxanthine containing drinks (coffee, tea, cola, energy drinks, chocolate, etc.).
  • Willingness to abstain from over the counter herbal medications for the duration of the study.
  • Acceptable medical history, physical examination and chest X-ray (at investigator's discretion) are required prior to entering the treatment phase of the study.
  • Willingness to abstain from the following starting 14 days prior to administration of study drug up until the end of the study: Grapefruit or grapefruit juice; Red wine; Seville oranges (marmalade); St. John's Wort or Milk Thistle.
  • Willingness to abstain from vigorous physical exercise during intense PK study days (Days 1 and 7).
  • Reasonable probability for completion of the study, including dosing requirements of TPV/r and risk for hepatic decompensation among subjects with mild and moderate hepatic insufficiency.

Who cannot join

  • Female subjects who are of reproductive potential who:
  • Have positive serum β-hCG (Human chorionic gonadotropin test for pregnancy) at Visit 1 or on Day 0.
  • Have not been using a barrier contraceptive method for at least 3 months prior to Day 0 (Visit 2).
  • Are not willing to use a reliable method of at least barrier contraception, during the trial and 60 days after completion/termination.
  • Are breast-feeding.
  • Participation in another trial with an investigational medicine within 60 days prior to Day 0 (Visit 2).
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  • Use of any medication listed in the protocol within 30 days prior to Day 0 (Visit 2).
  • Use of any pharmacological contraceptive (including oral or patch) for one month prior to study initiation and for the duration of the study. Use of implantable or injectable contraceptive agents is excluded for at least six months prior to study start.
  • Use of hormone replacement therapy with estrogen-based preparations for at least 1 month prior to study initiation and for the duration of the study.
  • Administration of antimicrobial agents within 10 days prior to Day 0 (Visit 2) or during the trial.
  • Subjects with a history of spontaneous bacterial peritonitis, advanced hepatic cirrhosis (including Child's-Pugh score >8), active esophageal variceal disease, or asterixis.
  • Subjects with active or untreated hepatocellular carcinoma or who test positive for serum alpha fetoprotein (>10mg/dL).
  • Subjects with active coagulopathy.
  • Have serological evidence of exposure to, or infection with, HIV.
  • Recent history of alcohol or substance abuse (within 6 months of study period).
  • Blood or plasma donations within 30 days prior to Day 0 (Visit 2).
  • Subjects with a seated systolic blood pressure either <100 mm Hg or >150 mm Hg; resting heart rate either <50 beats/min or >90 beats/min. For subjects with a resting heart rate below 50, or above 90, the investigator could discuss exclusion with the medical monitor on a case-by-case basis.
  • Subjects with a history of any illness or allergy that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering TPV and ritonavir (RTV).
  • Subjects who have had an acute illness within 2 weeks prior to Day 0 (Visit 2).
  • Current use of any medications to control symptoms of hepatic disease within 30 days prior to Day 0, (Visit 2) or for the duration of the trial.
  • Known hypersensitivity to TPV, Ritonavir or the sulphonamide class of drugs.
  • Inability to adhere to the requirements of the protocol.

About this study

Official title: An Open-label Study to Determine the Pharmacokinetics of Single-dose and/or Steady-state TPV/r 500/200 mg in Subjects With Mild and Moderate Hepatic Insufficiency

To determine the pharmacokinetics of single-dose and steady-state Tipranavir/Ritonavir (TPV/r) 500/200 mg in subjects with mild to moderate hepatic insufficiency

Being tested
Tipranavir (TPV), Ritonavir (r)
Medical subject headings
Hepatic Insufficiency

What participants receive

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

  • Tipranavir (TPV)Drug

  • Ritonavir (r)Drug

Study groups in NCT02249442
Study groupRoleWhat they receive
Scheme A, mild hepatic subjectsExperimentalmulti-dose
Receives: Drug: Tipranavir (TPV); Drug: Ritonavir (r)
Scheme B, moderate hepatic subjectsExperimentalsingle dose
Receives: Drug: Tipranavir (TPV); Drug: Ritonavir (r)

What is being measured

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

  1. AUC0-∞ (area under the concentration time curve of drug in plasma over the time interval from 0 extrapolated to infinity)

    Measured: Up to day 12 after first drug administration

  2. AUC0-12h (area under the concentration time curve of drug in plasma over the time interval from 0 to 12h)

    Measured: Up to 12 hours after drug administration

  3. Cmax (maximum concentration of drug in plasma)

    Measured: Up to day 12 after first drug administration

  4. Cp12h (drug concentration in plasma at 12 hours after administration) for the mild hepatic subjects

    Measured: Up to 12 hours (h) after drug administration

Secondary outcomes (8)

  1. time from dosing to the maximum concentration (tmax)

    Measured: Up to day 12 after first drug administration

  2. elimination half-life (t1/2)

    Measured: Up to day 12 after first drug administration

  3. oral clearance (CL/F)

    Measured: Up to day 12 after first drug administration

  4. volume of distribution (Vz/F)

    Measured: Up to day 12 after first drug administration

  5. Relationship between pharmacokinetic parameters and baseline covariates

    Covariates = age, weight, race, cigarette smoking and hepatic impairment

    Measured: Up to day 12 after first drug administration

  6. Relationship between pharmacokinetic parameters and baseline covariates

    Covariates = age, weight, race, cigarette smoking and the child-Pugh score as linear and quadratic terms

    Measured: Up to day 12 after first drug administration

  7. Number of patients with abnormal changes in clinical laboratory parameters

    Measured: Up to day 12 after first drug administration

  8. Number of patients with adverse events

    Measured: Up to day 12 after first drug administration

Timeline

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

  1. First posted25 Sep 2014 (estimated)
  2. Study start1 Oct 2003
  3. Primary completion1 Jun 2004

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02249442
Sponsor's protocol ID
1182.32
Status last verified
Jan 2025
First submitted
23 Sep 2014
Last updated
23 Jan 2025
Results posted
No
Individual data sharing
No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tipranavir (TPV) and Ritonavir (r) in people with Hepatic Insufficiency, 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 20 inclusion and 22 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 23 Jan 2025. 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?

AUC0-∞ (area under the concentration time curve of drug in plasma over the time interval from 0 extrapolated to infinity) (time frame: Up to day 12 after first drug administration). The study lists 4 primary outcomes in all. 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 NCT02249442.

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 23 Jan 2025.

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