- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02253836
Pharmacokinetic Study in Healthy Adult Volunteers to Assess the Interactions Between Steady-State Tipranavir and Atazanavir in the Presence of Ritonavir
A Single-Centre Open-Label Study in Healthy Adult Volunteers to Assess the Pharmacokinetic Interactions Between Steady-State TPV (500 mg) and Single-Dose and Steady-State Atazanavir (300 mg QD) in the Presence of Ritonavir (100 mg)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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 multiple large capsules without difficulty
Acceptable laboratory values that indicate adequate baseline organ function at screening visit:
- Laboratory values are considered to be acceptable if the severity of any parameter is ≤ Grade 1, based on the Division of AIDS/AIDS Clinical Trials Group Grading Scale
- All abnormal laboratory values > Grade 1 are subject to approval by the trial clinical monitor
- Acceptable medical history, physical examination, and 12-lead ECG at screening
Willingness to abstain from the following starting 2 weeks 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
- Willingness to abstain from alcohol starting 3 days prior to administration of any study medication up to the end of the study
Willingness to abstain from the following starting 3 days prior to pharmacokinetic (PK) sampling:
- Garlic supplements and Methylxanthine containing foods or drinks (including coffee, tea, cola, energy drinks, chocolate, etc.)
- Willingness to abstain from over-the-counter herbal medications for the duration of the study
- Must be a non-smoker
- Willingness to abstain from vigorous physical exercise during intensive PK Days 1, 9, 23, 24 and 32
- Reasonable probability for completion of the study
Exclusion Criteria:
Female subjects of reproductive potential who:
- Have positive serum 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
- Participation in another trial with an investigational medicine within 2 months prior to Day 0 of this study
- Use of any medication listed in the protocol within 30 days prior to Day 0 of this study
- Use of 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 of Depo-Provera within six months prior to Day 0 will be excluded from participation in this study
- Use of hormone replacement therapy within 1 month prior to Day 0 and anytime during the study
- Administration of antibiotics within 15 days prior to Day 0 and anytime during the study
History of acute illness within 60 days prior to Day 0
o 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 does not qualify as a healthy volunteer
- Have serological evidence of hepatitis B or C virus
- Have serological evidence of exposure to HIV
- Alcohol or substance abuse within 1 year prior to screening or during the study
- Blood or plasma donations within 30 days prior to Day 0 or during the study
- 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 Atazanavir to the subject
- Subjects with pre-existing heart conduction abnormalities
- 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 clinical monitor, might interfere with absorption, distribution, or metabolism of the study medications
- Known hypersensitivity to sulphonamide class of drugs
- Inability to adhere to the protocol
- Cautions or warnings in the Ritonavir and Atazanavir package insert which, in the opinion of the investigator, constitute grounds for subject exclusion
Study Plan
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: TAZ/RTV - TPV/RTV - TPV/RTV+TAZ
Days 1-9: single dose TAZ/RTV Days 16-23: morning and evening dose TPV/RTV Days 24-32: TPV/RTV + TAZ |
TPV
RTV
TAZ
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum plasma concentration
Time Frame: up to day 33
|
up to day 33
|
Drug concentration in plasma at 12 hr after administration for Tipranavir (TPV) and Ritonavir (RTV)
Time Frame: 12 hours after drug administration
|
12 hours after drug administration
|
Drug concentration in plasma at 24 hr after administration for Atazanavir (TAZ)
Time Frame: 24 hours after drug administration
|
24 hours after drug administration
|
Area under plasma concentration time curve from 0-12 hours (AUC0-12h) for TPV and RTV
Time Frame: up to 12 hours after drug administration
|
up to 12 hours after drug administration
|
AUC0-24h for TAZ
Time Frame: up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time from dosing to the maximum concentration
Time Frame: up to day 33
|
up to day 33
|
Elimination half-life
Time Frame: up to day 33
|
up to day 33
|
Oral clearance
Time Frame: up to day 33
|
up to day 33
|
Volume of distribution
Time Frame: up to day 33
|
up to day 33
|
Number of patients with adverse events
Time Frame: up to day 33
|
up to day 33
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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
- Protease Inhibitors
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Ritonavir
- Tipranavir
- Atazanavir Sulfate
Other Study ID Numbers
- 1182.61
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.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on Tipranavir
-
Boehringer IngelheimCompleted
-
Boehringer IngelheimCompleted
-
Boehringer IngelheimCompletedHIV InfectionsUnited States, Puerto Rico
-
Boehringer IngelheimCompleted
-
Boehringer IngelheimTerminated
-
Boehringer IngelheimApproved for marketingHIV InfectionsBelgium, Brazil, Canada, Denmark, El Salvador, Greece, Italy, Portugal, Spain
-
Boehringer IngelheimCompletedHIV InfectionsUnited States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Denmark, France, Germany, Greece, Italy, Mexico, Netherlands, Portugal, Spain, Switzerland, United Kingdom
-
Boehringer IngelheimApproved for marketingHIV InfectionsUnited States, Australia, Belgium, Denmark, France, Greece, Ireland, Italy, Portugal, South Africa, Switzerland, United Kingdom
-
Boehringer IngelheimWithdrawn
-
Boehringer IngelheimTerminatedHIV InfectionsUnited States, Argentina, Brazil, France, Germany, Italy, Spain