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HealthyPhase 1NCT02253836

Pharmacokinetic Study in Healthy Adult Volunteers to Assess the Interactions Between Steady-State Tipranavir and Atazanavir in the Presence of Ritonavir

A Phase 1 study testing Tipranavir, Ritonavir and Atazanavir 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 investigate the effects of steady-state TPV/r (500 mg/100 mg BID) on the single-dose and steady-state pharmacokinetics of Atazanavir (300 mg QD) co-administered with Ritonavir (100 mg). 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 Atazanavir
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
No sites listed yet
Study dates
Jan 2005to Jul 2005
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 at screening visit:
  • Laboratory values are considered to be acceptable if the severity of any parameter is ≤ Grade 1, based on the Division of AIDS/AIDS Clinical Trials Group Grading Scale
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  • All abnormal laboratory values > Grade 1 are subject to approval by the trial clinical monitor
  • Acceptable medical history, physical examination, and 12-lead ECG at screening
  • Willingness to abstain from the following starting 2 weeks prior to administration of any study medication and up until the end of the study:
  • Grapefruit or grapefruit juice, Red wine, Seville oranges, St. John's Wort, and Milk Thistle
  • Willingness to abstain from alcohol starting 3 days prior to administration of any study medication up to the end of the study
  • Willingness to abstain from the following starting 3 days prior to pharmacokinetic (PK) sampling:
  • Garlic supplements and Methylxanthine containing foods or drinks (including coffee, tea, cola, energy drinks, chocolate, etc.)
  • Willingness to abstain from over-the-counter herbal medications for the duration of the study
  • Must be a non-smoker
  • Willingness to abstain from vigorous physical exercise during intensive PK Days 1, 9, 23, 24 and 32
  • Reasonable probability for completion of the study

Who cannot join

  • Female subjects of reproductive potential who:
  • Have positive serum pregnancy test
  • Have not been using a barrier method of contraception for at least 3 months prior to participation in the study
  • Are not willing to use a reliable method of barrier contraception (such as diaphragm with spermicidal cream/jelly or condoms with spermicidal foam), during and 60 days after completion/termination of the trial
  • Are breast-feeding
  • Participation in another trial with an investigational medicine within 2 months prior to Day 0 of this study
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  • Use of any medication listed in the protocol within 30 days prior to Day 0 of this study
  • Use of any pharmacological contraceptive (including oral, patch or injectable contraceptives) within 1 month prior to Day 0 and for the duration of the study. Due to long half-life,subjects using of Depo-Provera within six months prior to Day 0 will be excluded from participation in this study
  • Use of hormone replacement therapy within 1 month prior to Day 0 and anytime during the study
  • Administration of antibiotics within 15 days prior to Day 0 and anytime during the study
  • History of acute illness within 60 days prior to Day 0
  • o Subjects will be excluded for acute illnesses that occurred more than 60 days prior to Day 0 if, in the opinion of the investigator, the subject does not qualify as a healthy volunteer
  • Have serological evidence of hepatitis B or C virus
  • Have serological evidence of exposure to HIV
  • Alcohol or substance abuse within 1 year prior to screening or during the study
  • Blood or plasma donations within 30 days prior to Day 0 or during the study
  • 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, Ritonavir or Atazanavir to the subject
  • Subjects with pre-existing heart conduction abnormalities
  • Subjects who have taken (within 7 days prior to Day 0) any over-the-counter or prescription medication that, in the opinion of the investigator in consultation with the clinical monitor, might interfere with absorption, distribution, or metabolism of the study medications
  • Known hypersensitivity to sulphonamide class of drugs
  • Inability to adhere to the protocol
  • Cautions or warnings in the Ritonavir and Atazanavir package insert which, in the opinion of the investigator, constitute grounds for subject exclusion

About this study

Official title: A Single-Centre Open-Label Study in Healthy Adult Volunteers to Assess the Pharmacokinetic Interactions Between Steady-State TPV (500 mg) and Single-Dose and Steady-State Atazanavir (300 mg QD) in the Presence of Ritonavir (100 mg)

Study to investigate the effects of steady-state TPV/r (500 mg/100 mg BID) on the single-dose and steady-state pharmacokinetics of Atazanavir (300 mg QD) co-administered with Ritonavir (100 mg). To investigate the effects of single-dose and steady-state Atazanavir (300 mg) on the steady-state pharmacokinetics of Tipranavir and Ritonavir.

Conditions
Healthy
Being tested
Tipranavir, Ritonavir, Atazanavir

What participants receive

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

  • TipranavirDrug

    TPV

  • RitonavirDrug

    RTV

  • AtazanavirDrug

    TAZ

Study groups in NCT02253836
Study groupRoleWhat they receive
TAZ/RTV - TPV/RTV - TPV/RTV+TAZExperimentalDays 1-9: single dose TAZ/RTV Days 16-23: morning and evening dose TPV/RTV Days 24-32: TPV/RTV + TAZ
Receives: Drug: Tipranavir; Drug: Ritonavir; Drug: Atazanavir

What is being measured

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

  1. Maximum plasma concentration

    Measured: up to day 33

  2. Drug concentration in plasma at 12 hr after administration for Tipranavir (TPV) and Ritonavir (RTV)

    Measured: 12 hours after drug administration

  3. Drug concentration in plasma at 24 hr after administration for Atazanavir (TAZ)

    Measured: 24 hours after drug administration

  4. Area under plasma concentration time curve from 0-12 hours (AUC0-12h) for TPV and RTV

    Measured: up to 12 hours after drug administration

  5. AUC0-24h for TAZ

    Measured: up to 24 hours after drug administration

Secondary outcomes (5)

  1. Time from dosing to the maximum concentration

    Measured: up to day 33

  2. Elimination half-life

    Measured: up to day 33

  3. Oral clearance

    Measured: up to day 33

  4. Volume of distribution

    Measured: up to day 33

  5. Number of patients with adverse events

    Measured: up to day 33

Timeline

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

  1. First posted1 Oct 2014 (estimated)
  2. Study startJan 2005
  3. Primary completionJul 2005

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
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02253836
Sponsor's protocol ID
1182.61
Status last verified
Sep 2014
First submitted
30 Sep 2014
Last updated
1 Oct 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tipranavir, Ritonavir and Atazanavir 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 17 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 1 Oct 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?

Maximum plasma concentration (time frame: up to day 33). The study lists 5 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 NCT02253836.

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 1 Oct 2014.

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