- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02245269
Pharmacokinetics of Atorvastatin With Tipranavir/Ritonavir and the Effect of Antacid on the Pharmacokinetics of Single-Dose Tipranavir/Ritonavir in Healthy Volunteers
September 18, 2014 updated by: Boehringer Ingelheim
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
23
Phase
- 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
Ages Eligible for Study
18 years to 22 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
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
- 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
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TPV/r + Atorvastatin followed by TPV/r + antacid
Day 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
|
Aluminum Hydroxide; Magnesium Hydroxide; Simethicone
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the plasma drug concentration-time curve from time zero to infinity of the analyte (AUC0-∞)
Time Frame: up to day 22
|
up to day 22
|
Maximum plasma concentration of the analyte (Cmax)
Time Frame: up to day 22
|
up to day 22
|
Drug concentration of the analyte in plasma at 12 hours after administration (Cp12h)
Time Frame: up to day 22
|
up to day 22
|
AUC0-12 hours of the analyte
Time Frame: up to day 22
|
up to day 22
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Oral clearance (CL/F)
Time Frame: up to day 22
|
up to day 22
|
Volume of distribution (V)
Time Frame: up to day 22
|
up to day 22
|
Time of maximum concentration (tmax)
Time Frame: up to day 22
|
up to day 22
|
Apparent terminal half life (t1/2)
Time Frame: up to day 22
|
up to day 22
|
Mean Residence Time (MRT)
Time Frame: up to day 22
|
up to day 22
|
Hepatic cytochrome P450 3A4 activity using the Erythromycin Breath Test
Time Frame: Days 7-10
|
Days 7-10
|
Number of patients with adverse events
Time Frame: up to day 22
|
up to day 22
|
Number of patients with clinically relevant changes in laboratory tests
Time Frame: up to day 22
|
up to day 22
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
July 1, 2003
Primary Completion (Actual)
October 1, 2003
Study Registration Dates
First Submitted
September 18, 2014
First Submitted That Met QC Criteria
September 18, 2014
First Posted (Estimate)
September 19, 2014
Study Record Updates
Last Update Posted (Estimate)
September 19, 2014
Last Update Submitted That Met QC Criteria
September 18, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antimetabolites
- Protease Inhibitors
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Atorvastatin
- Ritonavir
- Tipranavir
Other Study ID Numbers
- 1182.21
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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