- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02251145
Effects of Tipranavir (TPV) and Ritonavir (RTV) on the Pharmacokinetic Characteristics of Tenofovir Disoproxil Fumarate in Healthy Volunteers
25. september 2014 opdateret af: Boehringer Ingelheim
A Single Centre, Open-Label, Randomised, Parallel, Multiple Dose Comparison of the Effects of Tipranavir 500 mg and Ritonavir 100 mg or Tipranavir 750 mg and Ritonavir 200 mg Twice a Day for 11.5 Days on the Pharmacokinetic Characteristics of Tenofovir Disoproxil Fumarate 300 mg in Healthy Volunteers
Study to characterise the effects of two dose combinations of tipranavir/ritonavir (TPV 500 mg/RTV 100 mg and TPV 750 mg/RTV 200 mg) administered BID, on the pharmacokinetics of tenofovir disoproxil fumarate as well as the effects of tenofovir disoproxil fumarate on the pharmacokinetics of tipranavir/ritonavir.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
49
Fase
- Fase 1
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 60 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Ability and willingness to give written informed consent in accordance with institutional and regulatory 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
- A Body Mass Index >18.5 and <30 kg/m2
- Ability to swallow numerous large capsules without difficulty
- Reasonable probability for completion of the study, in the opinion of the investigator
- 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 <= Grade1 based on the AIDS Clinical Trials Group (ACTG) Division of AIDS (DAIDS) Grading Scale. All abnormal laboratory values > Grade 1 (e.g., creatine phosphokinase (CPK), amylase, triglycerides) are subject to approval by the BIPI clinical monitor. Cholesterol <= 240mg/dL at the time of screening is necessary for study entry
- Acceptable medical history, physical examination and ECG 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, 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 pharmacokinetic (PK) sampling days
- 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
Exclusion Criteria:
Female subjects who are of reproductive potential who:
- Have a positive serum B-HCG at Visit 1 or 2 or
- Have not been using regular oral contraception (combined oestrogen and progestogen pill or progestogen only pill) for 3 months and a barrier contraceptive method for at least 30 days prior to Visit 3 (Day 1) or 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)
- Ingestion of any known enzyme altering drug (such as phenothiazines, cimetidine, barbiturates, ketoconazole, fluconazole, rifampin, steroids, and herbal medications) for 30 days prior to Day 0 (Visit 2). Use of any other herbal/complementary treatment must be discussed in advance with the monitor and permission obtained prior to study entry
- Ingestion of grapefruit, grapefruit juice, and Cabernet Sauvignon within 15 days prior to Day 0 (Visit 2)
- 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 PK sampling days
- Ingestion of antibiotics within 10 days prior to Day 0 (Visit 2)
- Inability to comply with investigator's instructions
- History of gastrointestinal, hepatic, or renal disorders within 60 days
- History of alcohol abuse
- Current use of cigarettes defined as greater than 10 cigarettes per day or rolling/pipe tobacco equivalent
- 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 >100 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 or ritonavir or tenofovir disoproxil fumarate to the subject
- Subjects who have had an acute illness within 2 weeks prior to Day 0 (Visit 2)
- 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 and pharmacokineticist, might interfere with either the absorption, distribution or metabolism of the test substances
- Hypersensitivity to tipranavir, ritonavir, or tenofovir disoproxil fumarate
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: tipranavir/ritonavir low dose
|
|
Eksperimentel: tipranavir/ritonavir high dose
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Area under plasma concentration time curve from 0-24 hours (AUC0-24) for tenofovir
Tidsramme: up to 24 hours
|
up to 24 hours
|
Area under plasma concentration time curve from 0-12hours (AUC0-12) for tipranavir/ritonavir
Tidsramme: up to 12 hours
|
up to 12 hours
|
Maximum plasma concentration (Cmax)
Tidsramme: up to 24 hours
|
up to 24 hours
|
Drug concentration in plasma at 12 hours after administration (C12h) for tenofovir
Tidsramme: up to 12 hours
|
up to 12 hours
|
Drug concentration in plasma at 12 hours after administration (C12h) for tipranavir/ritonavir
Tidsramme: up to 12 hours
|
up to 12 hours
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Maksimal plasmakoncentration ved steady state (Cmax,ss)
Tidsramme: op til 24 timer
|
op til 24 timer
|
Trough plasma concentration at steady state (Cmin)
Tidsramme: up to 24 hours
|
up to 24 hours
|
Mean residency time (MRT)
Tidsramme: up to 24 hours
|
up to 24 hours
|
Apparent terminal half life (T1/2)
Tidsramme: up to 24 hours
|
up to 24 hours
|
Time of maximum concentration (Tmax)
Tidsramme: up to 24 hours
|
up to 24 hours
|
Oral clearance (CL/F)
Tidsramme: up to 24 hours
|
up to 24 hours
|
Apparent volume of distribution during the terminal elimination phase, divided by F (bioavailability factor) (Vz/F)
Tidsramme: up to 24 hours
|
up to 24 hours
|
Number of subjects with clinically significant findings in vital signs (pulse rate, blood pressure)
Tidsramme: up to 14 days
|
up to 14 days
|
Number of subjects with clinically significant findings in physical examination
Tidsramme: up to 14 days
|
up to 14 days
|
Number of subjects with clinically significant findings in electrocardiogram
Tidsramme: up to 14 days
|
up to 14 days
|
Number of subjects with clinically significant findings in laboratory tests
Tidsramme: up to 14 days
|
up to 14 days
|
Number of subjects with adverse events
Tidsramme: up to 14 days
|
up to 14 days
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. maj 2002
Primær færdiggørelse (Faktiske)
1. juni 2002
Datoer for studieregistrering
Først indsendt
25. september 2014
Først indsendt, der opfyldte QC-kriterier
25. september 2014
Først opslået (Skøn)
29. september 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
29. september 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. september 2014
Sidst verificeret
1. september 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Antivirale midler
- Reverse transkriptasehæmmere
- Nukleinsyresyntesehæmmere
- Enzymhæmmere
- Anti-HIV-midler
- Anti-retrovirale midler
- Proteasehæmmere
- Cytokrom P-450 CYP3A-hæmmere
- Cytokrom P-450 enzymhæmmere
- HIV-proteasehæmmere
- Virale proteasehæmmere
- Tenofovir
- Ritonavir
- Tipranavir
Andre undersøgelses-id-numre
- 1182.46
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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Vanderbilt University Medical CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)AfsluttetSund og raskForenede Stater
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CONRADNational Institute of Allergy and Infectious Diseases (NIAID)AfsluttetSund og rask | HIVForenede Stater
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Guy's and St Thomas' NHS Foundation TrustGilead Sciences; ViiV HealthcareAfsluttetHIV-1-infektionDet Forenede Kongerige
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