- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02245451
Study of Tipranavir and Ritonavir on the Pharmacokinetic Characteristics of Methadone Administered in Healthy Volunteers
September 18, 2014 updated by: Boehringer Ingelheim
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
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 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
- 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
Exclusion Criteria:
- 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.
- 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.
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: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TPV/r with methadone
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the concentration-time curve for 0 to 24 hours (AUC0-24h) of methadone
Time Frame: up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
Maximum concentration (Cmax)
Time Frame: up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
Concentration at 6 hours (C6h) of methadone
Time Frame: 6 hours after drug administration
|
6 hours after drug administration
|
Area under the concentration-time curve for 0 to 12 hours (AUC0-12h) of tipranavir and ritonavir
Time Frame: up to 12 hours after drug administration
|
up to 12 hours after drug administration
|
concentration at 12 hours (C12h) of tipranavir and ritonavir
Time Frame: 12 hours after drug administration
|
12 hours after drug administration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
mean residence time (MRT)
Time Frame: up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
apparent terminal half-life (t½)
Time Frame: up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
time to maximum concentration (Tmax)
Time Frame: up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
oral clearance (CL/F)
Time Frame: up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
apparent volume of distribution during the terminal elimination phase divided by the bioavailability factor (Vz/F)
Time Frame: up to 24 hours after drug administration
|
up to 24 hours after drug administration
|
Number of patients with abnormal findings in physical examination
Time Frame: Up to day 17 after first drug administration
|
Up to day 17 after first drug administration
|
Number of patients with clinically significant changes in vital signs
Time Frame: Up to day 17 after first drug administration
|
Up to day 17 after first drug administration
|
Number of patients with abnormal changes in clinical laboratory parameters
Time Frame: Up to day 17 after first drug administration
|
Up to day 17 after first drug administration
|
Number of participants with adverse events
Time Frame: Up to day 17 after first drug administration
|
Up to day 17 after first drug administration
|
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
January 1, 2005
Primary Completion (Actual)
February 1, 2005
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
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Analgesics
- Sensory System Agents
- Protease Inhibitors
- Analgesics, Opioid
- Narcotics
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Respiratory System Agents
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Antitussive Agents
- Ritonavir
- Tipranavir
- Methadone
Other Study ID Numbers
- 1182.26
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
-
King's College LondonUniversity of ReadingCompletedHealthy | Healthy AgingUnited Kingdom
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 IngelheimCompleted