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HealthyPhase 1NCT02245451

Study of Tipranavir and Ritonavir on the Pharmacokinetic Characteristics of Methadone Administered in Healthy Volunteers

A Phase 1 study testing Tipranavir, Ritonavir and Methadone 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 primary objective of this study is to characterise the effects of tipranavir 500 mg and ritonavir 200 mg (TPV/r; given twice daily) at steady-state on the pharmacokinetics of methadone administered as a single dose in healthy adult volunteers 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 Methadone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
No sites listed yet
Study dates
Jan 2005to Feb 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 or female healthy volunteers aged at least 18 to 60 years.
  • Clinically normal medical history.
  • Clinically normal findings on physical examination.
  • Clinically normal laboratory values.
  • A Body Mass Index >18.5 and <30 kg/m2.
  • Able to swallow large capsules without difficulty.
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  • Capable of comprehending and communicating effectively with the investigator and staff and of providing written informed consent in accordance with ethics committee and regulatory guidelines.
  • Willing to stay in the study centre for the duration of the study.
  • Willing to abstain from ingesting substances during the study which may alter plasma study drug levels by interaction with the cytochrome P450 system.
  • Willing to abstain from alcohol for 48 hours prior to Visit 1 and for the duration of the study. In addition, Cabernet Sauvignon must not have been ingested within 15 days prior to Visit 1.
  • Willing to abstain from ingesting grapefruit and grapefruit juice for 15 days before Visit 1 and for the duration of the study.
  • Willing to abstain from ingesting Seville oranges, strawberries or strawberry extract, garlic supplements, St. John's Wort, Milk Thistle, or methylxanthine-containing drinks or food (coffee, tea, cola, energy drinks, chocolate, etc) for 72 hours before the pharmacokinetic sampling days.
  • Willing 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

  • Any clinically significant disease. (A significant disease was defined as a disease which in the opinion of the investigator may either have put the subject at risk because of participation in the study or a disease which may have influenced the results of the study or the subject's ability to participate in the study.)
  • Clinically significant abnormal baseline haematology, blood chemistry or urinalysis findings.
  • Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), cholesterol, triglyceride or glucose greater than the upper limit of normal at Visit 1.
  • Treatment with prohibited medications in the thirty days before the study or during the study or ingestion of drugs of abuse.
  • Treatment with any investigational drug within 90 days of the first dose of study medication.
  • Inability to adhere to the requirements of the protocol (including active substance abuse) as assessed by the investigator.
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  • Prior tipranavir use.
  • Ingestion of any known enzyme altering drug (such as phenothiazines, cimetidine, barbiturates, ketoconazole, fluconazole, clarithromycin, rifampin, steroids, and herbal medications) for thirty days prior to Visit 1.
  • Ingestion of grapefruit, grapefruit juice, and Cabernet Sauvignon within fifteen days prior to Visit 1.
  • Ingestion of Seville oranges, strawberries or strawberry extract, 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 pharmacokinetics sampling days.
  • Treatment with prescription medicines within thirty days prior to Visit 1.
  • History of gastrointestinal, hepatic, or renal disorders within 60 days prior to Visit 1.
  • Any history of alcohol or drug abuse.
  • Current use of cigarettes defined as greater than 10 cigarettes per day or rolling/pipe tobacco equivalent.
  • Blood or plasma donations within 90 days prior to Visit 1
  • Subjects with a seated systolic blood pressure either <100 mm Hg or >150 mm Hg; resting heart rate either <50 beats/min or >100 beats/min.
  • Subjects with a history of any illness or allergy that, in the opinion of the investigator, might have confounded the results of the study or posed additional risk in administering tipranavir, ritonavir or methadone to the subject.
  • Subjects who had an acute illness within two weeks prior to Visit 1.
  • Subjects who were currently taking any over-the-counter drug within fourteen days prior to Visit 1 or who were currently taking any prescription drug.
  • Hypersensitivity to tipranavir, ritonavir, or methadone.
  • Female subjects who are of reproductive potential and who were pregnant, breastfeeding, had a positive serum B-HCG at Visit 1 or 2, had not been using a barrier contraceptive method for at least three months prior to Study Day 1 or were 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 study and for thirty days after completion or termination of the study.

About this study

Official title: A Single-centre, Open-label Study of Multiple Doses of Tipranavir 500 mg and Ritonavir 200 mg (Twice Daily) on the Pharmacokinetic Characteristics of Methadone Administered as a Single Dose in Healthy Volunteers

The primary objective of this study is to characterise the effects of tipranavir 500 mg and ritonavir 200 mg (TPV/r; given twice daily) at steady-state on the pharmacokinetics of methadone administered as a single dose in healthy adult volunteers

Conditions
Healthy
Being tested
Tipranavir, Ritonavir, Methadone

What participants receive

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

Study groups in NCT02245451
Study groupRoleWhat they receive
TPV/r with methadoneExperimentalNot described
Receives: Drug: Tipranavir; Drug: Ritonavir; Drug: Methadone

What is being measured

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

  1. Area under the concentration-time curve for 0 to 24 hours (AUC0-24h) of methadone

    Measured: up to 24 hours after drug administration

  2. Maximum concentration (Cmax)

    Measured: up to 24 hours after drug administration

  3. Concentration at 6 hours (C6h) of methadone

    Measured: 6 hours after drug administration

  4. Area under the concentration-time curve for 0 to 12 hours (AUC0-12h) of tipranavir and ritonavir

    Measured: up to 12 hours after drug administration

  5. concentration at 12 hours (C12h) of tipranavir and ritonavir

    Measured: 12 hours after drug administration

Secondary outcomes (9)

  1. mean residence time (MRT)

    Measured: up to 24 hours after drug administration

  2. apparent terminal half-life (t½)

    Measured: up to 24 hours after drug administration

  3. time to maximum concentration (Tmax)

    Measured: up to 24 hours after drug administration

  4. oral clearance (CL/F)

    Measured: up to 24 hours after drug administration

  5. apparent volume of distribution during the terminal elimination phase divided by the bioavailability factor (Vz/F)

    Measured: up to 24 hours after drug administration

  6. Number of patients with abnormal findings in physical examination

    Measured: Up to day 17 after first drug administration

  7. Number of patients with clinically significant changes in vital signs

    Measured: Up to day 17 after first drug administration

  8. Number of patients with abnormal changes in clinical laboratory parameters

    Measured: Up to day 17 after first drug administration

  9. Number of participants with adverse events

    Measured: Up to day 17 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 posted19 Sep 2014 (estimated)
  2. Study startJan 2005
  3. Primary completionFeb 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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02245451
Sponsor's protocol ID
1182.26
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 Methadone 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 16 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 concentration-time curve for 0 to 24 hours (AUC0-24h) of methadone (time frame: up to 24 hours after drug administration). 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 NCT02245451.

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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