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HealthyPhase 1NCT02249416

Comparison of the Effect of Tipranavir and Ritonavir or Tipranavir and Ritonavir on the Pharmacokinetic Characteristics of Zidovudine in Healthy Volunteers

A Phase 1 study testing Tipranavir (TPV) low, Ritonavir (RTV) low and Tipranavir (TPV) high 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

The objective of this study was to characterize the effect of two dose combinations of tipranavir/ritonavir (TPV 500 mg/RTV 100 mg and TPV 750 mg/RTV 200 mg) administered twice daily on the pharmacokinetics (PK) of zidovudine (ZDV) and zidovudine-glucuronide (GZDV) as well as the effects of zidovudine on the… 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) low, Ritonavir (RTV) low and Tipranavir (TPV) high
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
Nov 2001to Feb 2002
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

  • Ability and willingness to give written informed consent in accordance with institutional and federal guidelines and to comply with the investigational nature of the study and the related requirements
  • Healthy males or females between 18 and 60 years of age inclusive
  • A Body Mass Index between 18 and 35 kg/m2
  • Ability to swallow numerous large capsules without difficulty
  • Reasonable probability for completion of the study, in the opinion of the investigator
  • 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 <= Grade 1 based on the ACTG DAIDS Grading Scale. All abnormal laboratory values > Grade 1 (e.g., CPK, amylase, triglycerides) are subject to approval by the BIPI clinical monitor
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  • Acceptable medical history, physical examination, ECG, and Chest X-ray are required prior to entering 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, Cabernet Sauvignon must not have been ingested within 15 days prior to Day 0 (Visit 2)
  • Willingness to abstain from ingesting grapefruit and grapefruit juice within 15 days of Day 0, Visit 2 and for the duration of the study
  • Willingness to abstain from ingesting Seville oranges, garlic supplements, St. John's Wort, Milk Thistle, or methylxanthine-containing drinks or food (coffee, tea, cola, energy drinks, chocolate, etc.) within 72 hours of PK sampling days (Day 1 (Visit 3), Days 11-14 (Visits 5-8))
  • Willingness to abstain from use of tobacco products for the duration of the study
  • Urine drug screen negative for illegal non-prescription drugs
  • Negative HIV serology
  • Negative for Hepatitis B surface antigen and Hepatitis C

Who cannot join

  • Female subjects who are of reproductive potential who:
  • Have a positive serum B-HCG at Visit 1 or 2 or,
  • Have not been using a barrier contraceptive method for at least 3 months prior to Visit 3 (Day 1) or,
  • Are not willing to use a reliable method of double-barrier contraception (such as diaphragm with spermicidal cream/jelly or condoms with spermicidal foam) during the trial and 30 days after completion / termination or,
  • Are breast-feeding
  • Participation in another trial with an investigational medicine for 30 days prior to Day 0 (Visit 2)
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  • Ingestion of any known enzyme altering drug (such as phenothiazines, cimetidine, barbiturates, ketoconazole, fluconazole, rifampin, steroids, and herbal medications for 30 days prior to Day 0 (Visit 2)
  • Ingestion of grapefruit, grapefruit juice, and Cabernet Sauvignon within 15 days prior to Day 0 (Visit 2)
  • Ingestion of Seville oranges, garlic supplements, St. John's Wort, Milk Thistle, or methylxanthine-containing drinks or food (coffee, tea, cola, energy drinks, chocolate, etc.) within 72 hours of PK sampling days [Day 1 (Visit 3), Days 11-14 (Visits 5-8)]
  • Ingestion of antibiotics within 10 days prior to Day 0 (Visit 2)
  • Inability to comply with investigator's instructions
  • History of gastrointestinal, hepatic, or renal disorders within 60 days
  • History of alcohol abuse
  • Current use of cigarettes defined as greater than 10 cigarettes per day
  • 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
  • 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 or ritonavir or zidovudine 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 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 BIPI clinical monitor and pharmacokineticist, might interfere with either the absorption, distribution or metabolism of the test substances
  • Hypersensitivity to tipranavir, ritonavir, or zidovudine

About this study

Official title: A Single Center, Open-Label, Randomised, Parallel, Multiple Dose Comparison of the Effect of Tipranavir 500 mg and Ritonavir 100 mg or Tipranavir 750 mg and Ritonavir 200 mg Twice a Day for 11.5 Days on the Pharmacokinetic Characteristics of Zidovudine 300 mg in Healthy Volunteers

The objective of this study was to characterize the effect of two dose combinations of tipranavir/ritonavir (TPV 500 mg/RTV 100 mg and TPV 750 mg/RTV 200 mg) administered twice daily on the pharmacokinetics (PK) of zidovudine (ZDV) and zidovudine-glucuronide (GZDV) as well as the effects of zidovudine on the pharmacokinetics of TPV/RTV

Conditions
Healthy
Being tested
Tipranavir (TPV) low, Ritonavir (RTV) low, Tipranavir (TPV) high, Ritonavir (RTV) high, Zidovudine

What participants receive

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

  • Tipranavir (TPV) lowDrug

  • Ritonavir (RTV) lowDrug

    Norvir®

  • Tipranavir (TPV) highDrug

    Retrovir®

  • Ritonavir (RTV) highDrug

  • ZidovudineDrug

Study groups in NCT02249416
Study groupRoleWhat they receive
TPV/RTV low + ZDVExperimentalNot described
Receives: Drug: Tipranavir (TPV) low; Drug: Ritonavir (RTV) low; Drug: Zidovudine
TPV/RTV high + ZDVExperimentalNot described
Receives: Drug: Tipranavir (TPV) high; Drug: Ritonavir (RTV) high; Drug: Zidovudine

What is being measured

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

  1. Area under the concentration-time curve of the analyte in plasma from zero time to 12 hours (AUC0-12)

    Measured: Up to 12 h after drug administration

  2. Maximum plasma concentration (Cmax)

    Measured: Up to 24 h after drug administration

  3. Drug concentration in plasma at 6 hours after drug administration (Cp6h)

    Measured: Up to 6 h after drug administration

  4. Drug concentration in plasma at 12 hours after drug administration (Cp12h)

    Measured: Up to 12 h after drug administration

Secondary outcomes (11)

  1. Maximum plasma concentration at steady state (Cmax ss)

    Measured: Up to 24 h after drug administration

  2. Trough plasma concentration (Cmin)

    Measured: Up to 24 h after drug administration

  3. Mean residence time (MRT)

    Measured: Up to 24 h after drug administration

  4. Terminal half life (t1/2)

    Measured: Up to 24 h after drug administration

  5. Time of maximum concentration (tmax)

    Measured: Up to 24 h after drug administration

  6. Oral clearance (CL/F)

    Measured: Up to 24 h after drug administration

  7. Apparent volume of distribution during the terminal elimination phase (Vz/F)

    Measured: Up to 24 h after drug administration

  8. Number of participants with clinically significant changes in vital signs

    Measured: Up to day 14 after first drug administration

  9. Number of participants with abnormal findings in physical examination

    Measured: Up to day 14 after first drug administration

  10. Number of participants with abnormal changes in clinical laboratory parameters

    Measured: Up to day 14 after first drug administration

  11. Number of participants with Adverse Events

    Measured: Up to day 14 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 startNov 2001
  3. Primary completionFeb 2002

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02249416
Sponsor's protocol ID
1182.37
Status last verified
Sep 2014
First submitted
23 Sep 2014
Last updated
25 Sep 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tipranavir (TPV) low, Ritonavir (RTV) low and Tipranavir (TPV) high 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 20 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 25 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 concentration-time curve of the analyte in plasma from zero time to 12 hours (AUC0-12) (time frame: Up to 12 h after 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 NCT02249416.

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 25 Sep 2014.

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