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HealthyPhase 1NCT02195466

Effects of Single-dose and Steady-state TPV/RTV on the Steady-state Pharmacokinetics of Fluconazole in Healthy Adult Volunteers

A Phase 1 study testing Tipranavir (TPV), Ritonavir (RTV) and Fluconazole (FCZ) 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 effects of single-dose and steady-state TPV/RTV 500/200 mg on the steady-state pharmacokinetics of fluconazole 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 (TPV), Ritonavir (RTV) and Fluconazole (FCZ)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
Jun 2003to Jul 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 large capsules without difficulty
  • Acceptable laboratory values that indicate adequate baseline organ function are required at the time of screening. Laboratory values are considered to be acceptable if severity is less than or equal to Grade 1, based on the AIDS Clinical Trials Group (ACTG) Grading Scale. All abnormal laboratory values greater than Grade 1 are subject to approval by the trial clinical monitor
  • Acceptable medical history, physical examination, 12-lead electrocardiogram, and chest X-ray (if not conducted within the last 12 months and deemed necessary by investigator) are required prior to entering the treatment phase of the study
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  • Willingness to abstain from the following starting 14 days prior to any administration of study drugs up until the end of the study:
  • Grapefruit or grapefruit juice
  • Red wine
  • Seville oranges
  • St. John's Wort or Milk Thistle
  • Willingness to abstain from alcohol starting 2 days prior to administration study drug up to the end of the study
  • Willingness to abstain from the following within 72 hours of pharmacokinetics (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
  • Have been non-smokers for 3 months
  • Willingness to abstain from vigorous physical exercise during intensive PK Days 6, 7, 13
  • Reasonable probability for completion of the study

Who cannot join

  • Female subjects who are of reproductive potential and:
  • Have a positive serum β-human chorionic gonadotropin (hCG) at Visit 1, or on Day 0 or Day 1
  • Have not been using a barrier contraceptive method for at least 3 months prior to Visit 3 (Day 1)
  • Are not willing to use a reliable method of barrier contraception (such as diaphragm with spermicidal cream/jelly or condoms with spermicidal foam), 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 prohibited medication listed in the protocol within 30 days prior to Day 0 (Visit 2)
  • Use of any pharmacological contraceptive (including oral, patch or injectable contraceptives) within 1 month of study initiation and for the duration of the study. Use of Depo-Provera is excluded for six months prior to study initiation
  • Use of hormone replacement therapy within 1 month of study initiation and for the duration of the study
  • Administration of antibiotics within 10 days prior to Day 0 (Visit 2) or during the trial
  • History of acute illness within the past 60 days. Subjects will be excluded for these disorders greater than sixty days if, in the opinion of the investigator, the subject does not qualify as a healthy volunteer
  • History of thrombotic disease
  • History of migraine headache
  • Have serological evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV)
  • Have serological evidence of exposure to HIV
  • Recent history of alcohol or substance abuse (within 1 year of study period)
  • Blood or plasma donations within 30 days of Day 0 (Visit 2) or during the trial
  • 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 may 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, RTV or FCZ to the subject
  • Subjects who have had an acute illness within 2 weeks prior to Day 0 (Visit 2)
  • Subjects who are currently taking any over-the-counter or prescription drug within 7 days prior to Day 0 (Visit 2) that, in the opinion of the investigator in consultation with the Boehringer Ingelheim (Canada) Ltd./Ltée clinical monitor, might interfere with either the absorption, distribution or metabolism of the test substances
  • Known hypersensitivity to TPV, RTV, FCZ, or sulphonamide class of drugs
  • Inability to adhere to the protocol
  • Cautions or warnings in the FCZ package insert which, in the judgment of the investigator, should exclude a subject from the study

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/RTV 500/200 mg on the Steady-state Pharmacokinetics of Fluconazole 100 mg qd (200 mg Loading Dose)

Study to determine the effects of single-dose and steady-state TPV/RTV 500/200 mg on the steady-state pharmacokinetics of fluconazole

Conditions
Healthy
Being tested
Tipranavir (TPV), Ritonavir (RTV), Fluconazole (FCZ)

What participants receive

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

  • Tipranavir (TPV)Drug

    500 mg bid on days 7-14

  • Ritonavir (RTV)Drug

    200 mg bid on days 7-14

  • Fluconazole (FCZ)Drug

    200 mg loading dose on day 1, followed by 100 mg qd until day 13

Study groups in NCT02195466
Study groupRoleWhat they receive
TPV + RTV + FCZExperimentalNot described
Receives: Drug: Tipranavir (TPV); Drug: Ritonavir (RTV); Drug: Fluconazole (FCZ)

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 0-24 hours (AUC0-24h) for FCZ

    Measured: up to 24 hours after administration of study drug

  2. Maximum plasma concentration (Cmax) for FCZ

    Measured: up to 24 hours after administration of study drug

  3. Drug concentration in plasma at 24 hours after administration (Cp24h) for FCZ

    Measured: up to 24 hours after administration of study drug

Secondary outcomes (7)

  1. AUC0-12h for TPV

    Measured: up to 12 hours after administration of study drug

  2. Cmax for TPV

    Measured: up to 24 hours after administration of study drug

  3. Drug concentration in plasma at 12 hours after administration (Cp12h) for TPV

    Measured: up to 12 hours after administration of study drug

  4. Oral clearance (Cl/F) for FCZ and TPV

    Measured: up to 24 hours after administration of study drug

  5. Time of maximum concentration (tmax) for FCZ and TPV

    Measured: up to 24 hours after administration of study drug

  6. Apparent terminal half life (t1/2) for FCZ and TPV

    Measured: up to 24 hours after administration of study drug

  7. Number of patients with adverse events

    Measured: up to 6 weeks

Timeline

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

  1. First posted21 Jul 2014 (estimated)
  2. Study startJun 2003
  3. Primary completionJul 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
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02195466
Sponsor's protocol ID
1182.10
Status last verified
Jul 2014
First submitted
18 Jul 2014
Last updated
21 Jul 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tipranavir (TPV), Ritonavir (RTV) and Fluconazole (FCZ) 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 19 inclusion and 24 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 21 Jul 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 0-24 hours (AUC0-24h) for FCZ (time frame: up to 24 hours after administration of study drug). 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 NCT02195466.

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 21 Jul 2014.

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