Relative Bioavailability of Tipranavir (TPV)/Ritonavir (RTV) at Steady State Administered as Oral Solutions vs. Capsules in the Fed and Fasted State in Healthy Volunteers

August 26, 2014 updated by: Boehringer Ingelheim

An Open-label, Single-site, One-sequence Cross-over Study to Assess the Relative Bioavailability of TPV/r 500 mg/200 mg at Steady State When TPV and RTV Are Administered as Oral Solutions vs. Capsules in the Fed and Fasted State.

Study to establish the relative bioavailability of the TPV oral solution formulation (500 mg coadministered with RTV oral solution 200 mg) to the TPV capsule formulation (500 mg coadministered with RTV capsules 200 mg), with both treatments at steady-state under fasted and fed conditions in healthy male and female volunteers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male and female subjects 18 to 65 years of age inclusive
  2. A Body Mass Index (BMI): ≥18.5 and ≤35 kg/m2
  3. Signed informed consent prior to performance of any study procedures
  4. Ability to swallow multiple large capsules without difficulty
  5. Screening laboratory values within the normal range. Inclusion of any subject with an abnormal laboratory value was subject to approval by the BI trial clinical monitor
  6. Acceptable medical history, physical examination, and 12-lead ECG at screening

  7. Willingness to abstain from the following starting 5 days 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

  8. Willingness to abstain from the following starting 3 days prior to administration of any study medication up to the end of the study:

    • Garlic supplements and methylxanthine containing foods or drinks (including coffee, tea, cola, energy drinks, chocolate, etc.), apples and apple juice
  9. Willingness to abstain from over-the-counter herbal medications for the duration of the study
  10. Are non-smokers
  11. Willingness to abstain from vigorous physical exercise during intensive pharmacokinetic days 10, 11, 14, 15
  12. Reasonable probability for completion of the study

Exclusion Criteria:

  1. Participation in another trial with an investigational medicine within 2 months prior to Day 0 of this study

  2. Female subjects of reproductive potential who:

    • Have a positive 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
    • Use 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 Depo-Provera® within 6 months prior to Day 1 are excluded from participation in this study
    • Use of hormone replacement therapy within 1 month prior to Day 0 and anytime during the study
  3. Use of any medication listed in Protocol within 30 days prior to Day 0 of this study
  4. Administration of antibiotics within 15 days prior to Day 0 and anytime during the study

  5. History of acute illness within 60 days prior to Day 0

    • 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 did not qualify as a healthy volunteer
  6. Serological evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV)
  7. Serological evidence of exposure to HIV
  8. Alcohol or substance abuse within 1 year prior to screening or during the study
  9. Blood or plasma donations within 30 days prior to Day 0 or during the study
  10. 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 pose additional risk in administering TPV, or RTV to the subject
  11. 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 sponsor's clinical monitor, might have interfered with absorption, distribution, or metabolism of the study medications
  12. Known hypersensitivity to sulphonamide class of drugs
  13. Known hypersensitivity to TPV, RTV, or antiretroviral drugs (marketed or experimental use as part of clinical research studies)
  14. Known elevated liver enzymes in past trials with any compound
  15. Known allergy to nuts or nut products (A spoonful of peanut or hazelnut butter was taken immediately before administration of TPV or RTV oral solution, to help mask the taste of the solutions)
  16. Inability to adhere to the protocol
  17. Inability to consume a standard high-fat meal
  18. Cautions or warnings in the package insert which, in the opinion of the investigator, constituted grounds for subject exclusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TPV/RTV capsules fed
Drug: TPV capsule
Drug: RTV capsule
Other: standard meal
Experimental: TPV/RTV capsules fasted
Drug: TPV capsule
Drug: RTV capsule
Active Comparator: TPV/RTV solutions fed
Other: standard meal
Drug: TPV solution
Drug: RTV solution
Active Comparator: TPV/RTV solutions fasted
Drug: TPV solution
Drug: RTV solution

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Area under the concentration-time curve of TPV from time zero to 12 hours at steady state (AUC0-12)
Time Frame: up to 12 hours after drug administration
up to 12 hours after drug administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Area under the concentration-time curve of RTV from time zero to 12 hours at steady state (AUC0-12)
Time Frame: up to 12 hours after drug administration
up to 12 hours after drug administration
Maximum measured concentration of the analyte in plasma at steady state (Cmax)
Time Frame: up to 12 hours after drug administration
up to 12 hours after drug administration
Drug concentration in plasma after 12 hours at steady state (Cp12h)
Time Frame: up to 12 hours after drug administration
Drug concentration in plasma at last measurement (Cplast) if Cp12h is below limit of quantification (BLQ)
up to 12 hours after drug administration
Apparent clearance of the analyte in plasma at steady state following extravascular administration (CL/F)
Time Frame: up to 12 hours after drug administration
up to 12 hours after drug administration
Volume of distribution at steady state (Vd)
Time Frame: up to 12 hours after drug administration
up to 12 hours after drug administration
Terminal half life at steady state (t1/2)
Time Frame: up to 12 hours after drug administration
up to 12 hours after drug administration
Number of subjects with adverse events
Time Frame: up to day 16
up to day 16
Number of subjects with clinically significant findings in vital signs
Time Frame: up to day 16
blood pressure, pulse rate
up to day 16
Number of subjects with clinically significant findings in ECG
Time Frame: up to day 16
up to day 16
Number of subjects with clinically significant findings in laboratory tests
Time Frame: up to day 16
up to day 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2006

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1182.100

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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