- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01759875
Effects of Gastric pH on the Pharmacokinetics of Atazanavir
24. april 2015 opdateret af: University of California, San Francisco
Effects of Gastric pH on the Pharmacokinetics of Atazanavir in Healthy Volunteers
The goal of this study is to evaluate the ability of a natural supplement (betaine hydrochloride) to affect the absorption of atazanavir in healthy volunteers.
The investigators predict that betaine hydrochloride will increase the absorption of atazanavir in volunteers pre-treated with proton-pump inhibitors (PPIs).
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
8
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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California
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San Francisco, California, Forenede Stater, 94143
- Clinical Research Center, UCSF
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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 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Male or female 18-65 years of age
- Healthy adult with no active medical problems or significant chronic diseases as determined by the study doctor based on history, physical exam and laboratory evaluations
- BMI between 18.5-30 kg/m2
- Taking no medications 2 weeks before and during the study enrollment, including drugs of abuse, prescription or over-the-counter (OTC) medications (except acetaminophen)
- Subjects able to maintain adequate birth control during the study independent of hormonal contraceptive use
- Be able to provide written informed consent and comply with requirements of the study
- Avoid eating grapefruit and drinking grapefruit juice from 7 days before the first study day until the completion of the entire study
- Abstinence from alcoholic beverages, caffeinated beverages and orange juice from 3pm the night before a study day until completion of that study day
- Fast from food and beverages at least 8 hours prior to medication dosing
- Be able to read, speak, and understand English
Exclusion Criteria:
- Subjects with a history of gastrointestinal disease including gastroesophageal reflux disease, gastritis, peptic ulcer disease, or dyspepsia
- Subjects with a fasting gastric pH of > 4 (i.e. hypochlorhydria)
- Subjects with a history of dysphagia, achalasia, or difficulty swallowing capsules, tablets, or pills
- Subjects on prescription or chronic over-the-counter (OTC) medications (including hormonal contraceptives)
- Subjects with known allergies rabeprazole, any other proton pump inhibitors (PPI's) or betaine hydrochloride
- Subjects who smoke tobacco
- Subjects with ongoing alcohol or illegal drug use
- Subjects who are pregnant, lactating, or attempting to conceive
- Subjects unable to maintain adequate birth control during the study
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Ritonavir-boosted Atazanavir
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Ritonavir (100mg) PO x1 and Atazanavir (300mg) PO x1
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Eksperimentel: Ritonavir-boosted Atazanavir plus Rabeprazole
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Rabeprazole (20mg) PO twice daily (Days 1-3); Ritonavir (100mg) PO x1 and Atazanavir (300mg) PO x1 (Day 4)
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Eksperimentel: Ritonavir-boosted Atazanavir plus Rabeprazole AND Betaine HCl
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Rabeprazole (20mg) PO twice daily (Days 1-3); Betaine Hydrochloride (1500mg) PO x1 AND Ritonavir (100mg) PO x1 and Atazanavir (300mg) PO x1 on Day 4
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Area-Under-the Concentration Curve from zero-to-twenty two hours (AUC,0-22) of Atazanavir
Tidsramme: Day 4
|
The primary outcome measure will be atazanavir area-under-the-concentration curve (AUC) values from zero-to-twenty two (0-22) hours.
Values from Experimental Arms of the study (Ritonavir-boosted Atazanavir plus Rabeprazole; Ritonavir-boosted Atazanavir plus Rabeprazole AND Betaine Hydrochloride) will be compared against the active comparator (Ritonavir-boosted atazanavir alone) and tested for statistical significance.
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Day 4
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Area-Under-the Concentration Curve from zero-to-infinity (AUC,0-inf) of Atazanavir
Tidsramme: Day 4
|
The primary outcome measure will be atazanavir area-under-the-concentration curve (AUC) values from zero-to-infinite time (0-inf).
Values from Experimental Arms of the study (Ritonavir-boosted Atazanavir plus Rabeprazole; Ritonavir-boosted Atazanavir plus Rabeprazole AND Betaine Hydrochloride) will be compared against the active comparator (Ritonavir-boosted Atazanavir alone) and tested for statistical significance.
|
Day 4
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Maximum Concentration of Atazanavir
Tidsramme: Day 4
|
The maximum plasma concentration (Cmax) will also be measured.
Values from Experimental Arms of the study (Ritonavir-boosted Atazanavir plus Rabeprazole; Ritonavir-boosted Atazanavir plus Rabeprazole AND Betaine Hydrochloride) will be compared against the active comparator (Ritonavir-boosted Atazanavir alone) and tested for statistical significance.
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Day 4
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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. januar 2013
Primær færdiggørelse (Faktiske)
1. januar 2014
Studieafslutning (Faktiske)
1. januar 2014
Datoer for studieregistrering
Først indsendt
30. december 2012
Først indsendt, der opfyldte QC-kriterier
30. december 2012
Først opslået (Skøn)
3. januar 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
28. april 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. april 2015
Sidst verificeret
1. april 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Antivirale midler
- Enzymhæmmere
- Anti-HIV-midler
- Anti-retrovirale midler
- Antimetabolitter
- Gastrointestinale midler
- Proteasehæmmere
- Hypolipidæmiske midler
- Lipidregulerende midler
- Cytokrom P-450 CYP3A-hæmmere
- Cytokrom P-450 enzymhæmmere
- Anti-ulcus midler
- Protonpumpehæmmere
- HIV-proteasehæmmere
- Virale proteasehæmmere
- Lipotrope midler
- Ritonavir
- Rabeprazol
- Atazanavirsulfat
- Betain
Andre undersøgelses-id-numre
- CRS6537
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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