- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT00867152
GSK1349572 Drug Interaction With Etravirine and Either Darunavir/Ritonavir or Lopinavir/Ritonavir
20 lutego 2012 zaktualizowane przez: ViiV Healthcare
A Phase I, Open Label, Randomized, Three Period, One-way, Two Cohort, Adaptive Crossover Study to Evaluate the Effect of Darunavir/Ritonavir Plus Etravirine and Lopinavir/Ritonavir Plus Etravirine on GSK1349572 Pharmacokinetics in Healthy Adult Subjects (ING112934)
A Phase I, open label, randomized, three period, one-way, two cohort, adaptive crossover study to evaluate the effect of darunavir/ritonavir plus etravirine and lopinavir/ritonavir plus etravirine on GSK1349572 pharmacokinetics in healthy adult subjects
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Szczegółowy opis
The study is a three period, randomized, open label study.
Approximately 18 healthy subjects will receive GSK1349572 50mg q24h for 5 days (Treatment A) in Period 1. Subjects will then be administered GSK1349572 50mg q24h in combination with either LPV/RTV 400/100 mg q12h and etravirine 200mg q12h (Treatment B, n=9) or DRV/RTV 600/100 mg q12h and etravirine 200mg q12h (Treatment C, n=9) for 14 days in Period 2 followed by a washout period.
GSK1349572 PK data will be obtained from Periods 1 and 2 and used to inform decision making on Period 3. If GSK1349572 Cτ is reduced by more than 50% in Period 2 compared to Period 1, subjects will return to the clinic and receive GSK1349572 50mg q12h in combination with ETV and either DRV/RTV or LPV/RTV in Period 3. Safety evaluations and serial PK samples will be collected during each treatment period.
A follow-up visit will occur 7-14 days after the last dose of study drug.
All doses of study drugs will be taken following a moderate fat meal.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
17
Faza
- Faza 1
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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New York
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Buffalo, New York, Stany Zjednoczone, 14202
- GSK Investigational Site
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat do 65 lat (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
Inclusion Criteria:
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- Male or female between 18 and 65 years of age, inclusive.
- A female subject is eligible to participate if she is of non-childbearing potential (i.e., physiologically incapable of becoming pregnant) including any female who: Is pre-menopausal with a documented bilateral tubal ligation, bilateral oophorectomy (removal of the ovaries) or hysterectomy, or Is postmenopausal defined as 12 months of spontaneous amenorrhea. A follicle stimulating hormone (FSH) level will be performed to confirm a post-menopausal status. For this study, FSH levels of > 40 MlU/ml is confirmatory. For females on hormone replacement therapy (HRT) and whose menopausal status is in doubt, HRT should be discontinued for 2 weeks and then the subject rescreened, as HRT can suppress FSH.
- Male subjects must agree to use one of the contraception methods listed in the protocol. This criterion must be followed from the time of the first dose of study medication until 14 days after the last dose of study medication.
- Body weight ≥ 50 kg for men and ≥ 45 kg for women and BMI within the range 18.5-31.0 kg/m2 (inclusive).
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). A single repeat is allowed for eligibility determination.
Exclusion Criteria:
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- A positive test for HIV antibody.
- A positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids, and benzodiazepines.
- History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 g of alcohol: 12 ounces (360 ml) of beer, 5 ounces (150 ml) of wine or 1.5 ounces (45 ml) of 80 proof distilled spirits.
- History of regular use of tobacco or nicotine-containing products within 3 months prior to screening.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- Consumption of red wine, seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication.
- History of sensitivity to any of the study medications, or components thereof including sulfa-containing drugs, or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- Pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing.
- Lactating females.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- If heparin is used in during PK sampling, subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia should not be enrolled.
- History of significant renal or hepatic diseases.
- History/evidence of clinically significant pulmonary disease.
- History/evidence of symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PCTA) or any clinically significant cardiac disease.
- Subjects with a pre-existing condition interfering with normal gastrointestinal anatomy or motility, hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the study drugs. Subjects with a history of cholecystectomy, peptic ulceration, inflammatory bowel disease or pancreatitis should be excluded.
- Serum creatinine values greater than the upper limit of normal. A single repeat is allowed for eligibility determination.
- The subject's systolic blood pressure is outside the range of 90-140mmHg, or diastolic blood pressure is outside the range of 45-90mmHg or heart rate is outside the range of 50-100bpm for female subjects or 45-100bpm for male subjects.
- Screening ECG outside protocol limits (a single repeat is allowed for eligibility determination)
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Podstawowa nauka
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Cohort 2
All subjects will receive GSK1349572 50mg q24h (Treatment A) from Day 1 to Day 5 in Period 1.
There will be no washout between treatment Periods 1 and 2. Subjects will receive GSK1349572 50mg q24h and ETV/DRV/RTV 200/600/100mg q12h from Day 1 to Day 14 in Period 2. Day 1 of Period 3 will be approximately 3 weeks after the last dose in Period 2. Subjects will receive GSK1349572 50mg q12h and ETV/DRV/RTV 200/600/100mg q12h from Day 1 to Day 14. Period 3 will not be performed if there is no significant interaction in Period 2.
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Darunavir 600 mg every 12 hours for 14 days in Periods 2 and 3. Period 3 may not be done.
Darunavir is approved by the FDA as an HIV medication in the protease inhibitor class.
Inne nazwy:
Etravirine 200 mg every 12 hours for 14 days in Periods 2 and 3. Period 3 may not be done.
Etravirine is approved by the FDA as an HIV medication in the non-nucleoside reuptake inhibitor class.
Inne nazwy:
Ritonavir 100 mg every 12 hours for 14 days in Periods 2 and 3. Period 3 may not be done.
Ritonavir is approved by the FDA as an HIV medication in the protease inhibitor class.
Inne nazwy:
GSK1349572 50 q24h for 5 days in Period 1 and for 14 days in Period 2. GSK1349572 20 mg q12h for 14 days in Period 3 if Period 3 is done.
GSK1349572 is an investigational (not approved by the FDA) HIV medication in the integrase inhibitor class.
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Eksperymentalny: Cohort 1
All subjects will receive GSK1349572 50mg q24h (Treatment A) from Day 1 to Day 5 in Period 1.
There will be no washout between treatment Periods 1 and 2. Subjects will receive GSK1349572 50mg q24h and ETV/LPV/RTV 200/400/100mg q12h from Day 1 to Day 14 in Period 2. Day 1 of Period 3 will be approximately 3 weeks after the last dose in Period 2. Subjects will receive GSK1349572 50mg q12h and ETV/LPV/RTV 200/400/100mg q12h from Day 1 to Day 14. Period 3 will not be performed if there is no significant interaction in Period 2.
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Etravirine 200 mg every 12 hours for 14 days in Periods 2 and 3. Period 3 may not be done.
Etravirine is approved by the FDA as an HIV medication in the non-nucleoside reuptake inhibitor class.
Inne nazwy:
GSK1349572 50 q24h for 5 days in Period 1 and for 14 days in Period 2. GSK1349572 20 mg q12h for 14 days in Period 3 if Period 3 is done.
GSK1349572 is an investigational (not approved by the FDA) HIV medication in the integrase inhibitor class.
Lopinavir 400 mg and ritonavir 100 mg every 12 hours for 14 days in Periods 2 and 3. Period 3 may not be done.
Lopinavir/Ritonavir is approved by the FDA as an HIV medication in the protease inhibitor class.
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
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Plasma GSK1349572 steady-state AUC(0-τ), Cmax, C0, Cτ, and Cmin following administration of GSK1349572 50mg and following co-administration of GSK1349572 50mg with ETV/LPV/RTV 200/400/100mg or ETV/DRV/RTV 200/600/100mg
Ramy czasowe: 14 days
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14 days
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Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
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Safety and tolerability parameters, including adverse event, concurrent medication, clinical laboratory, ECG, and vital signs assessments.
Ramy czasowe: 12 weeks
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12 weeks
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Plasma ETV PK parameters, including AUC(0-τ), Cmax, and Cmin following co-administration of GSK1349572 50mg q24h (and 50mg q12h if appropriate) and ETV/LPV/RTV 200/400/100mg q12h or ETV/DRV/RTV 200/600/100mg q12h
Ramy czasowe: 14 days
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14 days
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GSK1349572 PK parameters, including, tmax, tmin, CL/F and t½ following administration of GSK1349572 50mg q24h for 5 days and following co-administration of GSK1349572 50mg and ETV/LPV/RTV 200/400/100mg q12h or ETV/DRV/RTV 200/600/100mg
Ramy czasowe: 14 days
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14 days
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Współpracownicy
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 kwietnia 2009
Zakończenie podstawowe (Rzeczywisty)
1 maja 2009
Ukończenie studiów (Rzeczywisty)
1 maja 2009
Daty rejestracji na studia
Pierwszy przesłany
20 marca 2009
Pierwszy przesłany, który spełnia kryteria kontroli jakości
20 marca 2009
Pierwszy wysłany (Oszacować)
23 marca 2009
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
22 lutego 2012
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
20 lutego 2012
Ostatnia weryfikacja
1 lutego 2012
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Molekularne mechanizmy działania farmakologicznego
- Środki przeciwinfekcyjne
- Środki przeciwwirusowe
- Inhibitory odwrotnej transkryptazy
- Inhibitory syntezy kwasów nukleinowych
- Inhibitory enzymów
- Agenci przeciw HIV
- Środki przeciwretrowirusowe
- Inhibitory proteazy
- Inhibitory cytochromu P-450 CYP3A
- Inhibitory enzymów cytochromu P-450
- Inhibitory integrazy HIV
- Inhibitory integrazy
- Inhibitory proteazy HIV
- Inhibitory wirusowych proteaz
- Rytonawir
- Lopinawir
- Darunawir
- Etrawiryna
- Dolutegrawir
Inne numery identyfikacyjne badania
- 112934
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Darunavir
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Fundación Pública Andaluza para la Investigación...Merck Sharp & Dohme LLCNieznany