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HealthyPhase 1NCT02253823

Multiple Dose Comparison of the Effect of Two Dose Combinations of Tipranavir/Ritonavir (TPV/RTV), on the Pharmacokinetic Characteristics of Efavirenz (Sustiva®) in Healthy Adult Volunteers

A Phase 1 study testing EFV, TPV/RTV - low dose and TPV/RTV - high dose 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 effects of two dose combinations of tipranavir/ritonavir (TPV 500 mg/RTV 100 mg and TPV 750 mg/RTV 200 mg), administered daily and BID, on the pharmacokinetics of efavirenz (EFV), 600 mg daily 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?
EFV, TPV/RTV - low dose and TPV/RTV - high dose
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
No sites listed yet
Study dates
Dec 2001to Mar 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
  • Ability to swallow numerous large capsules without difficulty
  • Reasonable probability for completion of the study
  • A Body Mass Index (BMI) between 18 and 35 kg/m2
  • 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 Adult AIDS Clinical Trial Group (ACTG) Division of Acquired Immunodeficiency Syndrome (of the National Institute of Allergy and Infectious Diseases / National Institutes of Health) (DAIDS) Grading Scale. All abnormal laboratory values > Grade 1 (e.g., creatine phosphokinase (CPK), amylase, triglycerides) are subject to approval by the Boehringer Ingelheim Pharmaceuticals, Inc. (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 [Visit 3 (Days 1-6), Visit 4 (Days 12-15), Visit 5 (Days 20-21 and Visit 6 (Day 22)]
  • 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-human chronic gonadotropin (HCG) at Visit 1 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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  • Use of any known enzyme altering drug (such as phenothiazines, cimetidine, barbiturates, ketoconazole, fluconazole, rifampin, steroids, and herbal medications within 30 days prior to Day 0 (Visit 2) or during the trial
  • 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 pharmacokinetics (PK) sampling days [Visit 3 (Days 1-6), Visit 4 (Days 12-15), Visit 5 (Days 20-21 and Visit 6 (Day 22)]
  • Administration of antibiotics within 10 days prior to Day 0 (Visit 2) or during the trial
  • Inability to comply with investigator's instructions
  • History of central nervous system (CNS), gastrointestinal, hepatic, or renal disorders within the past 60 days. Subjects were excluded for these disorders greater than sixty days, if in the opinion of the investigator, the subject did not qualify as a healthy volunteer
  • History of alcohol abuse
  • Excessive cigarettes smoking 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. For subjects with a resting heart rate below 50, due to high fitness level, the investigator could discuss exclusion with medical monitor on a case-by-case basis
  • 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 efavirenz to the subject
  • Subjects who have an acute illness within 2 weeks prior to Day 0 (Visit 2).
  • Subjects who are taking any over-the-counter drug within 7 days prior to Day 0, (Visit 2) or are 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
  • Subjects suffering from active forms of depression
  • Subjects that had a history of suicidal ideations
  • Known hypersensitivity to tipranavir, ritonavir, or efavirenz

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, Administered Daily on 3 Non-Consecutive Days and Twice Daily for 7 Days, on the Pharmacokinetic Characteristics of Efavirenz (Sustiva®) 600 mg a Day in Healthy Adult Volunteers

The objective of this study was to characterize the effects of two dose combinations of tipranavir/ritonavir (TPV 500 mg/RTV 100 mg and TPV 750 mg/RTV 200 mg), administered daily and BID, on the pharmacokinetics of efavirenz (EFV), 600 mg daily

Conditions
Healthy
Being tested
EFV, TPV/RTV - low dose, TPV/RTV - high dose

What participants receive

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

  • EFVDrug

  • TPV/RTV - low doseDrug

  • TPV/RTV - high doseDrug

Study groups in NCT02253823
Study groupRoleWhat they receive
TPV+RTV - low doseExperimentalNot described
Receives: Drug: EFV; Drug: TPV/RTV - low dose
TPV+RTV - high doseExperimentalNot described
Receives: Drug: EFV; Drug: TPV/RTV - high dose

What is being measured

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

  1. Cmax (Maximum measured concentration of the analyte in plasma)

    Measured: up to 24 hours after drug administration

  2. AUC 0-12 (Area under the plasma concentration time curve from 0-12 hours)

    Measured: up to 12 hours after drug administration

  3. Cp12h (observed drug concentration in plasma at 12 hours)

    Measured: up to 12 hours after drug administration

  4. AUC 0-24 (Area under the plasma concentration time curve from 0-24 hours)

    Measured: up to 24 hours after drug administration

  5. Cp24h (observed drug concentration in plasma at 24 hours)

    Measured: up to 24 hours after drug administration

Secondary outcomes (6)

  1. CL/F (Apparent clearance of the analyte in plasma following extravascular administration)

    Measured: up to 24 hours after drug administration

  2. V (Volume of distribution)

    Measured: up to 24 hours after drug administration

  3. Tmax (Time from dosing to the maximum concentration of the analyte in plasma)

    Measured: up to 24 hours after drug administration

  4. t½ (Terminal half-life of the analyte in plasma)

    Measured: up to 24 hours after drug administration

  5. Number of subjects with adverse events

    Measured: up to 43 days

  6. Number of subjects with abnormal changes in laboratory parameters

    Measured: up to 43 days

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 startDec 2001
  3. Primary completionMar 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
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02253823
Sponsor's protocol ID
1182.41
Status last verified
Sep 2014
First submitted
25 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 EFV, TPV/RTV - low dose and TPV/RTV - high dose 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 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?

Cmax (Maximum measured concentration of the analyte in plasma) (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 NCT02253823.

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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