- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02251145
Effects of Tipranavir (TPV) and Ritonavir (RTV) on the Pharmacokinetic Characteristics of Tenofovir Disoproxil Fumarate in Healthy Volunteers
25 september 2014 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Interventionell
Inskrivning (Faktisk)
49
Fas
- Fas 1
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 60 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: tipranavir/ritonavir low dose
|
|
Experimentell: tipranavir/ritonavir high dose
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Area under plasma concentration time curve from 0-24 hours (AUC0-24) for tenofovir
Tidsram: up to 24 hours
|
up to 24 hours
|
Area under plasma concentration time curve from 0-12hours (AUC0-12) for tipranavir/ritonavir
Tidsram: up to 12 hours
|
up to 12 hours
|
Maximum plasma concentration (Cmax)
Tidsram: up to 24 hours
|
up to 24 hours
|
Drug concentration in plasma at 12 hours after administration (C12h) for tenofovir
Tidsram: up to 12 hours
|
up to 12 hours
|
Drug concentration in plasma at 12 hours after administration (C12h) for tipranavir/ritonavir
Tidsram: up to 12 hours
|
up to 12 hours
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Maximal plasmakoncentration vid steady state (Cmax,ss)
Tidsram: upp till 24 timmar
|
upp till 24 timmar
|
Trough plasma concentration at steady state (Cmin)
Tidsram: up to 24 hours
|
up to 24 hours
|
Mean residency time (MRT)
Tidsram: up to 24 hours
|
up to 24 hours
|
Apparent terminal half life (T1/2)
Tidsram: up to 24 hours
|
up to 24 hours
|
Time of maximum concentration (Tmax)
Tidsram: up to 24 hours
|
up to 24 hours
|
Oral clearance (CL/F)
Tidsram: up to 24 hours
|
up to 24 hours
|
Apparent volume of distribution during the terminal elimination phase, divided by F (bioavailability factor) (Vz/F)
Tidsram: up to 24 hours
|
up to 24 hours
|
Number of subjects with clinically significant findings in vital signs (pulse rate, blood pressure)
Tidsram: up to 14 days
|
up to 14 days
|
Number of subjects with clinically significant findings in physical examination
Tidsram: up to 14 days
|
up to 14 days
|
Number of subjects with clinically significant findings in electrocardiogram
Tidsram: up to 14 days
|
up to 14 days
|
Number of subjects with clinically significant findings in laboratory tests
Tidsram: up to 14 days
|
up to 14 days
|
Number of subjects with adverse events
Tidsram: up to 14 days
|
up to 14 days
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 maj 2002
Primärt slutförande (Faktisk)
1 juni 2002
Studieregistreringsdatum
Först inskickad
25 september 2014
Först inskickad som uppfyllde QC-kriterierna
25 september 2014
Första postat (Uppskatta)
29 september 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
29 september 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
25 september 2014
Senast verifierad
1 september 2014
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Molekylära mekanismer för farmakologisk verkan
- Anti-infektionsmedel
- Antivirala medel
- Omvända transkriptashämmare
- Nukleinsyrasynteshämmare
- Enzyminhibitorer
- Anti-HIV-medel
- Antiretrovirala medel
- Proteashämmare
- Cytokrom P-450 CYP3A-hämmare
- Cytokrom P-450 enzymhämmare
- HIV-proteashämmare
- Virala proteashämmare
- Tenofovir
- Ritonavir
- Tipranavir
Andra studie-ID-nummer
- 1182.46
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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