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HealthyPhase 1NCT02251769

Effects of Single-dose and Steady-state TPV/r on the Steady-state Pharmacokinetics of Clarithromycin and a Preliminary Assessment of the Effects of a Standard High-fat Test Meal on the Steady-state Pharmacokinetics of Tipranavir

A Phase 1 study testing Tipranavir, Ritonavir and Clarithromycin 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

To determine the effects of single-dose and steady-state Tipranavir/Ritonavir (TPV/r) at 500 mg/200 mg bid on the steady-state pharmacokinetics of clarithromycin and to determine the effects of a standard high-fat test meal on the steady-state pharmacokinetics of tipranavir. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Tipranavir, Ritonavir and Clarithromycin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
No sites listed yet
Study dates
Aug 2003to Sep 2003
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 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male and female subjects between 18 and 60 years of age inclusive
  • A Body Mass Index (BMI) between 18 and 29 kg/m2
  • Signed informed consent prior to trial participation
  • Ability to swallow multiple capsules without difficulty
  • Ability to ingest a standard high-fat test meal
  • Acceptable laboratory values that indicated adequate baseline organ function were required at the time of screening. Laboratory values were considered to be acceptable if severity was less than or equal to Grade 1, based on the AIDS Clinical Trials Group (ACTG) Grading Scale
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  • Acceptable medical history, physical examination and 12-lead ECG were required prior to entering the treatment phase of the study
  • Willingness to abstain from alcohol for 48 hours prior to study Day 0 and abstain from alcohol for the duration of the study. In addition, ingestion of red wine is not allowed within 5 days prior to Day 0 (Visit 2)
  • Willingness to abstain from grapefruit or grapefruit juice or products containing grapefruit juice starting 10 days prior to any administration of study drug up until the end of the study
  • Willingness to abstain from ingestion of Seville oranges, garlic supplements, St. John's Wort, or Milk Thistle, within 5 days of treatment and for the duration of the study
  • Willingness to abstain from methylxanthine-containing drinks or foods (coffee, tea, cola, energy drinks, chocolate, etc.) within 48 hours of each pharmacokinetic sampling day and until after the last sample from each of the intensive sampling days was collected
  • Willingness to abstain from over the counter herbal medications for the duration of the study
  • Willingness to abstain from vigorous physical exercise during intensive pharmacokinetic days
  • Reasonable probability for completion of the study
  • Non-smokers for at least 3 months prior to Day 0

Who cannot join

  • Female subjects who are of reproductive potential and who:
  • Have positive serum β-hCG at Visit 1, or on Day 0
  • Are not using a barrier contraceptive method for at least 3 months prior to Visit 2 (Day 0)
  • Are not willing to use a reliable method of barrier contraception (such as diaphragm or condoms), during the trial and for 30 days after trial completion/termination
  • Are breast-feeding
  • Use of any pharmacological contraceptive (including oral, patch or injectable contraceptives) within 1 month prior to study initiation and for the duration of the study
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  • Use of hormone replacement therapy within 1 month prior to study initiation and for the duration of the study
  • Participation in another trial with an investigational medicine within 60 days prior to Day 0 (Visit 2)
  • Use of any prohibited medication listed in the protocol within 30 days prior to Day 0 (Visit 2)
  • Administration of antibiotics within 10 days prior to Day 0 (Visit 2) or during the trial
  • History of acute illness within 60 days of trial initiation. Subjects are excluded for these disorders greater than 60 days if, in the opinion of the investigator, the subject does not qualify as a healthy volunteer
  • Serological evidence of hepatitis B (HBV) or hepatitis C (HCV)
  • Serological evidence of exposure to 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) or during the trial
  • Subjects with a seated systolic blood pressure either <100 mm Hg or >150 mm Hg
  • 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 tipranavir (TPV), ritonavir (RTV) or clarithromycin (CLR) to the subject
  • Subjects who have taken, within 7 days prior to Day 0 (Visit 2), any over-the-counter or prescription drugs that, in the opinion of the investigator in consultation with the BI clinical monitor, might interfere with either the absorption, distribution or metabolism of the test substances
  • Known hypersensitivity to TPV, RTV, sulfonamides, or CLR
  • Lactose intolerance or intolerance to high-fat foods
  • Allergies or intolerance to foods such as soybean, wheat, milk, eggs or gluten
  • Inability to adhere to requirements of the protocol

About this study

Official title: A Single-centre Open-label Study in Healthy Adult Volunteers to Determine the Effects of Single-dose and Steady-state TPV/r (500 mg/200 mg) on the Steady-state Pharmacokinetics of Clarithromycin (BIAXIN®) 500 mg Bid and a Preliminary Assessment of the Effects of a Standard High-fat Test Meal on the Steady-state Pharmacokinetics of Tipranavir

To determine the effects of single-dose and steady-state Tipranavir/Ritonavir (TPV/r) at 500 mg/200 mg bid on the steady-state pharmacokinetics of clarithromycin and to determine the effects of a standard high-fat test meal on the steady-state pharmacokinetics of tipranavir.

Conditions
Healthy
Being tested
Tipranavir, Ritonavir, Clarithromycin, High-Fat Test Meal

What participants receive

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

Study groups in NCT02251769
Study groupRoleWhat they receive
Sequential administrationExperimentalNot described
Receives: Drug: Tipranavir; Drug: Ritonavir; Drug: Clarithromycin; Other: High-Fat Test Meal

What is being measured

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

  1. Area under plasma concentration time curve from 0-12 hours (AUC0-12h)

    Measured: up to 12 hours

  2. Maximum plasma concentration (Cmax)

    Measured: up to 12 hours

  3. Plasma trough concentration (Cp12h)

    Measured: up to 12 hours

Secondary outcomes (7)

  1. Oral clearance (CL/F)

    Measured: up to 12 hours

  2. Volume of distribution (V)

    Measured: up to 12 hours

  3. Apparent terminal half life (t1/2)

    Measured: up to 12 hours

  4. Time of maximum concentration (Tmax)

    Measured: up to 12 hours

  5. Mean Residency Time (MRT)

    Measured: up to 12 hours

  6. Number of patients with adverse events

    Measured: up to day 13

  7. Number of patients with clinically significant laboratory findings

    Measured: up to day 13

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 2003
  3. Primary completionSep 2003

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02251769
Sponsor's protocol ID
1182.11
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 Clarithromycin 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 15 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 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?

Area under plasma concentration time curve from 0-12 hours (AUC0-12h) (time frame: up to 12 hours). The study lists 3 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 NCT02251769.

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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