Effects of Tipranavir (With Ritonavir) Capsule and Liquid Formulation on Cytochrome P450 and P-glycoprotein Activity in Healthy Volunteers
NCT ID: NCT02243553
Last Updated: 2014-09-18
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
PHASE1
Total Enrollment
34 participants
Study Classification
INTERVENTIONAL
Study Start Date
2006-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Primary: To quantify the influence of single-dose and steady-state tipranavir/ritonavir 500/200 mg on intestinal and hepatic cytochrome P450 (CYP) and P-glycoprotein (P-gp) biomarkers, as a means of predicting drug interactions. The AUCs for biomarkers caffeine, warfarin, omeprazole, dextromethorphan, midazolam, and digoxin will be assessed.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pharmacokinetics of Tipranavir/Ritonavir and Its Metabolites in Healthy Male Subjects
NCT02253797
Healthy
COMPLETED
PHASE1
Pharmacokinetics of Tipranavir Soft Elastic Capsules (SEDDS) and Ritonavir and Their Effects on Cytochrome P-450 (3A4) in Healthy Volunteers
NCT02251132
Healthy
COMPLETED
PHASE1
Pharmacokinetic Interaction Between Tipranavir and BILR 355 BS Plus Ritonavir in Healthy Male Volunteers
NCT02257021
Healthy
COMPLETED
PHASE1
Effects of BI 201335 NA on Cytochrome P450 and P-glycoprotein Activity Using a Probe Drug Cocktail in Healthy Volunteers
NCT02182336
Healthy
COMPLETED
PHASE1
Pharmacokinetics of Single Doses of BILR 355 BS Given With Ritonavir in Healthy Male Volunteers
NCT02253953
Healthy
COMPLETED
PHASE1
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Healthy
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment A
tipranavir (TPV) capsule + ritonavir (RTV) capsule + cocktail + digoxin oral
Group Type
EXPERIMENTAL
Tipranavir capsule
Intervention Type
DRUG
Ritonavir capsule
Intervention Type
DRUG
Caffeine
Intervention Type
DRUG
Warfarin sodium
Intervention Type
DRUG
Vitamin K
Intervention Type
DRUG
Omeprazole
Intervention Type
DRUG
Dextromethorphan hydrobromide
Intervention Type
DRUG
Midazolam injection
Intervention Type
DRUG
Midazolam oral solution
Intervention Type
DRUG
Digoxin tablet
Intervention Type
DRUG
Treatment B
TPV capsule + RTV capsule + cocktail + digoxin injection
Group Type
EXPERIMENTAL
Tipranavir capsule
Intervention Type
DRUG
Ritonavir capsule
Intervention Type
DRUG
Caffeine
Intervention Type
DRUG
Warfarin sodium
Intervention Type
DRUG
Vitamin K
Intervention Type
DRUG
Omeprazole
Intervention Type
DRUG
Dextromethorphan hydrobromide
Intervention Type
DRUG
Midazolam injection
Intervention Type
DRUG
Midazolam oral solution
Intervention Type
DRUG
Digoxin injection
Intervention Type
DRUG
Treatment C
TPV solution + RTV capsule + cocktail + digoxin oral
Group Type
EXPERIMENTAL
Tipranavir solution
Intervention Type
DRUG
Ritonavir capsule
Intervention Type
DRUG
Caffeine
Intervention Type
DRUG
Warfarin sodium
Intervention Type
DRUG
Vitamin K
Intervention Type
DRUG
Omeprazole
Intervention Type
DRUG
Dextromethorphan hydrobromide
Intervention Type
DRUG
Midazolam injection
Intervention Type
DRUG
Midazolam oral solution
Intervention Type
DRUG
Digoxin tablet
Intervention Type
DRUG
Treatment D
TPV solution + RTV capsule + cocktail + digoxin injection
Group Type
EXPERIMENTAL
Tipranavir solution
Intervention Type
DRUG
Ritonavir capsule
Intervention Type
DRUG
Caffeine
Intervention Type
DRUG
Warfarin sodium
Intervention Type
DRUG
Vitamin K
Intervention Type
DRUG
Omeprazole
Intervention Type
DRUG
Dextromethorphan hydrobromide
Intervention Type
DRUG
Midazolam injection
Intervention Type
DRUG
Midazolam oral solution
Intervention Type
DRUG
Digoxin injection
Intervention Type
DRUG
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tipranavir capsule
Intervention Type
DRUG
Tipranavir solution
Intervention Type
DRUG
Ritonavir capsule
Intervention Type
DRUG
Caffeine
Intervention Type
DRUG
Warfarin sodium
Intervention Type
DRUG
Vitamin K
Intervention Type
DRUG
Omeprazole
Intervention Type
DRUG
Dextromethorphan hydrobromide
Intervention Type
DRUG
Midazolam injection
Intervention Type
DRUG
Midazolam oral solution
Intervention Type
DRUG
Digoxin tablet
Intervention Type
DRUG
Digoxin injection
Intervention Type
DRUG
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Signed informed consent
2. Healthy subjects aged between 18 years and 45 years inclusive
3. Weighing at least 50 kg
4. Volunteers must be hospitalized on Days 1-4, 7-9, and 17-20 for pharmacokinetic assessments for each biomarker and TPV/r (Days 7-9 and 17-20)
5. Volunteers must be willing to complete all study-related activities
6. Each volunteer must have a valid social security number
7. Each volunteer must have acceptable medical history, physical examination and laboratory test
2. Healthy subjects aged between 18 years and 45 years inclusive
3. Weighing at least 50 kg
4. Volunteers must be hospitalized on Days 1-4, 7-9, and 17-20 for pharmacokinetic assessments for each biomarker and TPV/r (Days 7-9 and 17-20)
5. Volunteers must be willing to complete all study-related activities
6. Each volunteer must have a valid social security number
7. Each volunteer must have acceptable medical history, physical examination and laboratory test
Exclusion Criteria
1. History or presence of allergy to the study drugs or their components or drugs of their class, or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation
2. Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance
3. History or diagnosis of any significant medical conditions: Including but not limited to gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hematological, psychiatric, neurological, oncological or hormonal disorders
4. Known elevated liver enzymes in past clinical trials with any compound (experimental or marketed)
5. Clinically relevant laboratory abnormalities (e.g. Hgb\<11g/dL, Hct\<30g/dL, total cholesterol \>240mg/dL, triglycerides \>500mg/dL, fasting glucose \>130mg/dL, liver function tests \>2.5x upper limit of normal, baseline international normalized ratio \>1.2)
6. History of evidence of clinically significant hepatic, cardiac, pulmonary, endocrine, immunological, gastrointestinal, hematological, vascular or collagen disease
7. History of alcohol abuse or use of any illicit drugs
8. Unable to abstain from more than one beer or alcohol equivalent per day for the duration of the study
9. Use of tobacco products and/or history of smoking within the past 2 months
10. Pregnant or breast feeding
11. Sexually active women of childbearing age who do not use an acceptable barrier method of birth control
12. Hypersensitivity to caffeine, warfarin, vitamin K, omeprazole, dextromethorphan, midazolam, tipranavir, ritonavir or their excipients
13. Concomitant treatment with other experimental compounds
14. Concomitant administration of any prescription or over the counter medications known to alter P450 enzyme or P-gp activity
15. Concomitant administration of any prescription or over the counter medications known to be highly dependent on P450 or P-gp for clearance for which elevated plasma concentrations are known to be associated with serious toxicity
16. Concomitant administration of any food product known to alter P450 enzyme or P-gp activity such as grapefruit juice, Seville oranges
17. Concomitant administration of any drug that could affect bleeding (e.g., aspirin, clopidogrel, ticlopidine, warfarin, heparin, low-molecular weight heparin)
18. Concomitant administration of oral contraceptives (may be included with 7-day washout period)
19. Concomitant administration of any herbal medications
20. Inadequate venous access
21. Renal or hepatic insufficiency
22. Clinically unacceptable result at the screening physical examination
23. Use of investigational medications within 30 days before study entry
24. HIV-positive
25. Body Mass Index (BMI) \> 30 kg/m²
2. Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) deviating from normal and of clinical relevance
3. History or diagnosis of any significant medical conditions: Including but not limited to gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hematological, psychiatric, neurological, oncological or hormonal disorders
4. Known elevated liver enzymes in past clinical trials with any compound (experimental or marketed)
5. Clinically relevant laboratory abnormalities (e.g. Hgb\<11g/dL, Hct\<30g/dL, total cholesterol \>240mg/dL, triglycerides \>500mg/dL, fasting glucose \>130mg/dL, liver function tests \>2.5x upper limit of normal, baseline international normalized ratio \>1.2)
6. History of evidence of clinically significant hepatic, cardiac, pulmonary, endocrine, immunological, gastrointestinal, hematological, vascular or collagen disease
7. History of alcohol abuse or use of any illicit drugs
8. Unable to abstain from more than one beer or alcohol equivalent per day for the duration of the study
9. Use of tobacco products and/or history of smoking within the past 2 months
10. Pregnant or breast feeding
11. Sexually active women of childbearing age who do not use an acceptable barrier method of birth control
12. Hypersensitivity to caffeine, warfarin, vitamin K, omeprazole, dextromethorphan, midazolam, tipranavir, ritonavir or their excipients
13. Concomitant treatment with other experimental compounds
14. Concomitant administration of any prescription or over the counter medications known to alter P450 enzyme or P-gp activity
15. Concomitant administration of any prescription or over the counter medications known to be highly dependent on P450 or P-gp for clearance for which elevated plasma concentrations are known to be associated with serious toxicity
16. Concomitant administration of any food product known to alter P450 enzyme or P-gp activity such as grapefruit juice, Seville oranges
17. Concomitant administration of any drug that could affect bleeding (e.g., aspirin, clopidogrel, ticlopidine, warfarin, heparin, low-molecular weight heparin)
18. Concomitant administration of oral contraceptives (may be included with 7-day washout period)
19. Concomitant administration of any herbal medications
20. Inadequate venous access
21. Renal or hepatic insufficiency
22. Clinically unacceptable result at the screening physical examination
23. Use of investigational medications within 30 days before study entry
24. HIV-positive
25. Body Mass Index (BMI) \> 30 kg/m²
Minimum Eligible Age
18 Years
Maximum Eligible Age
45 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boehringer Ingelheim
INDUSTRY
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1182.101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
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
NCT02227017
COMPLETED
PHASE1
Bioavailability of Tipranavir/Ritonavir Paediatric Solution Compared to Tipranavir/Ritonavir Capsules in Healthy Female and Male Subjects
NCT02251158
COMPLETED
PHASE1
Bioequivalence Study of Tipranavir Stored at Controlled Temperature Compared With Tipranavir Stored at Controlled Refrigerated Conditions, Orally Co-administered With Ritonavir in Healthy Male and Female Volunteers
NCT02253888
COMPLETED
PHASE1
Bioequivalence of Two Different Oral Solutions Tipranavir Administered in Combination With Ritonavir to Healthy Volunteers
NCT02244190
COMPLETED
PHASE1
A Pharmacokinetic And Bioavailability Study of Intravenous Danoprevir in Healthy Volunteers
NCT01654211
COMPLETED
PHASE1
Effects of TPV/r on the Pharmacokinetics of Carbamazepine in Healthy Adult Volunteers
NCT02253849
COMPLETED
PHASE1
A Study to Test How BI 1015550 is Taken up in the Blood of People With and Without Liver Problems
NCT05661344
COMPLETED
PHASE1
Effects of Single-dose and Steady-state TPV/r on the Steady-state Pharmacokinetics of Clarithromycin and a Preliminary Assessment of the Effects of a Standard High-fat Test Meal on the Steady-state Pharmacokinetics of Tipranavir
NCT02251769
COMPLETED
PHASE1
Bioavailability of BI 1356 After Co-administration With Ritonavir Compared to the Bioavailability of BI 1356 Alone in Healthy Male Volunteers
NCT02183441
COMPLETED
PHASE1
Relative Bioavailability of a Single-dose Administration of BIBW 2992 and Multiple-dose Administration of Ritonavir in Healthy Volunteers
NCT02171754
COMPLETED
PHASE1
Bioavailability and Pharmacokinetics of BI 135585 XX Administered as Tablet With and Without Food
NCT01286571
COMPLETED
PHASE1
A Study to Compare the Pharmacokinetics and Safety of Mitapivat 100 mg Tablet Formulation With Mitapivat 2 × 50 mg Tablet Formulation in Healthy Adult Participants
NCT04696393
COMPLETED
PHASE1
Pharmacokinetics and Safety of BILR 355 in Healthy Male Volunteers
NCT02253940
COMPLETED
PHASE1
TMC278-TiDP6-C130: Pharmacokinetics, Safety and Tolerability of TMC278 in Subjects With Mildly or Moderately Impaired Hepatic Function.
NCT00736905
COMPLETED
PHASE1
Pharmacokinetic Interaction Between TRUVADA™ and BILR 355 BS Plus Ritonavir in Healthy Volunteers
NCT02253901
COMPLETED
PHASE1
Safety, Tolerability and Pharmacokinetics of BI 44370 TA Oral Drinking Solution in Healthy Male Volunteers
NCT02215018
COMPLETED
PHASE1
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of RO6889678 and the Combination of RO6889678 With Ritonavir in Healthy Participants
NCT02321384
TERMINATED
PHASE1
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 11634 Solution in Healthy Male Volunteers
NCT02214914
COMPLETED
PHASE1
Pharmacokinetics of KBP-5074 in Patients With Moderate Hepatic Impairment
NCT04534699
COMPLETED
PHASE1
Pharmacodynamics, Safety and Pharmacokinetics After Oral Administration of BIBR 1048 MS in Healthy Volunteers
NCT02170116
COMPLETED
PHASE1
Pharmacokinetic Interaction Between Maraviroc And Fosamprenavir/Ritonavir In Healthy Subjects
NCT01290211
COMPLETED
PHASE1
Tolerability and Pharmacokinetics/-Dynamics of BIBT 986 BS in Healthy Male Subjects
NCT02254083
COMPLETED
PHASE1
A Study of MK-1084 in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017)
NCT07219550
RECRUITING
PHASE1
Effect of BIBT 986 Followed by BIBT 986 Given as IV Infusion on Tissue Factor Triggered Coagulation in Healthy Male Volunteers
NCT02259881
COMPLETED
PHASE1
Pharmacokinetic (PK) Profiles of Tenofovir Disoproxil Fumarate (TDF) 300 mg in Healthy Chinese Subjects
NCT01480622
COMPLETED
PHASE1