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HealthyPhase 1NCT02245269

Pharmacokinetics of Atorvastatin With Tipranavir/Ritonavir and the Effect of Antacid on the Pharmacokinetics of Single-Dose Tipranavir/Ritonavir in Healthy Volunteers

A Phase 1 study testing Tipranavir, Ritonavir and Atorvastatin 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 combined tipranavir and ritonavir treatment (at steady-state) on the single-dose pharmacokinetics of atorvastatin, the effects of single-dose atorvastatin on the steady-state pharmacokinetics of tipranavir, and the effects of antacid on the pharmacokinetics of tipranavir Read more about this study

Who is it for?
Ages 18 to 22 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Tipranavir, Ritonavir and Atorvastatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
No sites listed yet
Study dates
Jul 2003to Oct 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 22 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 numerous study medications
  • 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 Grading Scale
  • Acceptable medical history, physical examination and ECG, and chest X-ray (if not conducted within the last 12 months) are required prior to entering the treatment phase of the study
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  • Willingness to abstain from alcohol starting 2 days prior to any administration study drug up to the end of the study. Red wine must not be ingested within 5 days prior to treatment and throughout the study
  • Willingness to abstain from the following starting 10 days prior to any administration of study drug up until the end of the study:
  • Grapefruit or grapefruit juice or products containing grapefruit juice
  • Willingness to abstain from ingesting 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 72 hours of each pharmacokinetic (PK) sampling day and until after the last sample from each of the intensive sampling days is collected
  • Willingness to abstain from over the counter herbal medications for the duration of the study
  • Willingness to abstain from vigorous physical exercise during PK Days
  • Reasonable probability for completion of the study

Who cannot join

  • Female subjects who are of reproductive potential who:
  • Have positive serum β-human chorionic gonadotropin 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 barrier contraception (such as diaphragm or condoms), during the trial and 30 days after completion/termination
  • Are breast-feeding
  • Use of any pharmacological contraceptive (including oral, patch or injectable contraceptives) for 1 month prior to study initiation and for the duration of the study
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  • Use of hormone replacement therapy for 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 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 the past sixty (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
  • Have serological evidence of Hepatitis B or C Virus
  • Have serological evidence of exposure to HIV
  • Recent history of alcohol or substance abuse (within 6 months of study period)
  • Smokers who smoke greater than 10 cigarettes or 3 cigars or 3 pipes per day; inability to refrain from smoking during the trial
  • 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; resting heart rate either <50 beats/min or >90 beats/min
  • 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, atorvastatin or erythromycin to the subject
  • Subjects who are currently taking any over-the-counter drug within 7 days prior to Day 0,(Visit 2) or who are currently taking any prescription drug that, in the opinion of the investigator in consultation with the clinical monitor, might interfere with either the absorption, distribution or metabolism of the test substances
  • Known hypersensitivity to Tipranavir,Ritonavir, sulfonamides, atorvastatin, erythromycin or saccharin
  • Inability to comply with the protocol

About this study

Official title: A Two-way Pharmacokinetic Interaction Study of Single-Dose Atorvastatin (LIPITOR®) With Tipranavir/Ritonavir (500mg/200mg) at Steady-State and the Effect of Antacid (MAALOX®) on the Pharmacokinetics of Single-Dose Tipranavir/Ritonavir (500mg/200mg) in Healthy Volunteers

Study to determine the effects of combined tipranavir and ritonavir treatment (at steady-state) on the single-dose pharmacokinetics of atorvastatin, the effects of single-dose atorvastatin on the steady-state pharmacokinetics of tipranavir, and the effects of antacid on the pharmacokinetics of tipranavir

Conditions
Healthy
Being tested
Tipranavir, Ritonavir, Atorvastatin, Maalox

What participants receive

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

  • TipranavirDrug

  • RitonavirDrug

  • AtorvastatinDrug

  • MaaloxDrug

    Aluminum Hydroxide; Magnesium Hydroxide; Simethicone

Study groups in NCT02245269
Study groupRoleWhat they receive
TPV/r + Atorvastatin followed by TPV/r + antacidExperimentalDay 1: first dose of ATV Day 8: single dose of TPV/r Day 13: single dose of TPV/r, followed by a single dose of Maalox Days 14-21: morning and evening doses of TPV/r on Day 20: second dose of ATV
Receives: Drug: Tipranavir; Drug: Ritonavir; Drug: Atorvastatin; Drug: Maalox

What is being measured

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

  1. Area under the plasma drug concentration-time curve from time zero to infinity of the analyte (AUC0-∞)

    Measured: up to day 22

  2. Maximum plasma concentration of the analyte (Cmax)

    Measured: up to day 22

  3. Drug concentration of the analyte in plasma at 12 hours after administration (Cp12h)

    Measured: up to day 22

  4. AUC0-12 hours of the analyte

    Measured: up to day 22

Secondary outcomes (8)

  1. Oral clearance (CL/F)

    Measured: up to day 22

  2. Volume of distribution (V)

    Measured: up to day 22

  3. Time of maximum concentration (tmax)

    Measured: up to day 22

  4. Apparent terminal half life (t1/2)

    Measured: up to day 22

  5. Mean Residence Time (MRT)

    Measured: up to day 22

  6. Hepatic cytochrome P450 3A4 activity using the Erythromycin Breath Test

    Measured: Days 7-10

  7. Number of patients with adverse events

    Measured: up to day 22

  8. Number of patients with clinically relevant changes in laboratory tests

    Measured: up to day 22

Timeline

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

  1. First posted19 Sep 2014 (estimated)
  2. Study startJul 2003
  3. Primary completionOct 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
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02245269
Sponsor's protocol ID
1182.21
Status last verified
Sep 2014
First submitted
18 Sep 2014
Last updated
19 Sep 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tipranavir, Ritonavir and Atorvastatin 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 14 inclusion and 21 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 19 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 the plasma drug concentration-time curve from time zero to infinity of the analyte (AUC0-∞) (time frame: up to day 22). 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 NCT02245269.

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 19 Sep 2014.

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