- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01277718
A Study to Evaluate the Effect of a Proton-Pump Inhibitor (Rabeprazole) on the Relative Bioavailability of Cobimetinib in Healthy Participants
4. april 2017 opdateret af: Genentech, Inc.
A Phase 1, Open-Label, 3-Period, Randomized, Crossover Study to Evaluate the Effect of a Proton-Pump Inhibitor (Rabeprazole) on the Relative Bioavailability of GDC-0973 in Healthy Subjects
This is a Phase 1, single-center, open-label, randomized, 3-period, 2-sequence crossover study of cobimetinib in healthy participants to evaluate the effect of the proton-pump inhibitor (PPI) rabeprazole on the relative bioavailability of cobimetinib in healthy participants when administered in the fed or fasted states.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
20
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 55 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria
- With a body mass index range of 18.5 to 29.9 kilograms per meter square (kg/m^2)
- In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), and vital signs
- Clinical laboratory evaluations within the reference range for the test laboratory
- Negative test for selected drugs of abuse at Screening (does not include alcohol) and at each Check-in
- Negative hepatitis panel (including hepatitis B virus surface antigen [HBsAg] and hepatitis C virus antibody [anti-HCV]) and negative human immunodeficiency virus (HIV) antibody screens
- Healthy males and females of nonchildbearing potential who agree to use effective contraception
Exclusion Criteria
- Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs, except that appendectomy, hernia repair, and/or cholecystectomy will be allowed
- History or presence of an abnormal ECG
- History of alcoholism or drug addiction within 1 year prior to Period 1 Check-in
- Use of any tobacco- or nicotine-containing products within 6 months prior to Period 1 Check-in
- Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 30 days or 5 half-lives, whichever is longer, prior to Period 1 Check-in
- Use of any prescription medications/products within 14 days prior to Period 1 Check-in
- Use of any over-the-counter, non-prescription preparations within 7 days prior to Period 1 Check-in
- Use of alcohol-, grapefruit-, or caffeine-containing foods or beverages within 72 hours prior to Period 1 Check-in
- Poor peripheral venous access
- Any acute or chronic condition that would limit the participant's ability to complete and/or participate in this clinical study
- Female participant is pregnant, lactating, or breastfeeding
- Use of PPIs or histamine H2 receptor antagonists within 1 month prior to Period 1 Check-in
- Known hypersensitivity to rabeprazole or any of its components or to derived products of benzimidazoles
- Predisposing factors to retinal vein occlusion (RVO)
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: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Treatment A first, then Treatment B, followed by Treatment C
Treatment A in Period 1: One 20-mg tablet of cobimetinib will be administered orally with 240 milliliters (mL) room temperature water after at least an 8-hour fast.
Treatment B in Period 2: 20 mg oral rabeprazole will be administered once daily for 4 days starting on Day -4.
On Day 1, 20 mg rabeprazole will be administered in fasted state followed by one 20-mg tablet of cobimetinib administration orally with 240 mL room temperature water after at least an 8-hour fast.
Treatment C in Period 3: 20 mg oral rabeprazole will be administered once daily for 4 days starting on Day -4.
On Day 1, 20 mg rabeprazole will be administered in fasted state.
Approximately 30 minutes later, participants will be provided a standardized Food and Drug Administration (FDA) high-fat meal, and approximately 30 minutes after starting meal, one 20-mg tablet of cobimetinib will be administered orally with 240 mL room temperature water.
There will be a 13-day washout between cobimetinib doses of each period.
|
One 20-mg tablet of cobimetinib will be administered orally with 240 mL room temperature water after at least an 8-hour fast or approximately 30 minutes after starting the standardized FDA high-fat meal.
Andre navne:
Rabeprazole 20 mg will be administered orally once daily for 4 days starting on Day -4 and on Day 1 of the treatment period.
|
|
Eksperimentel: Treatment A first, then Treatment C, followed by Treatment B
Treatment A in Period 1: One 20-mg tablet of cobimetinib will be administered orally with 240 mL room temperature water after at least an 8-hour fast.
Treatment C in Period 2: 20 mg oral rabeprazole will be administered once daily for 4 days starting on Day -4.
On Day 1 of the treatment period, 20 mg rabeprazole will be administered in fasted state.
Approximately 30 minutes later, participants will be provided a standardized FDA high-fat meal, and approximately 30 minutes after starting meal, one 20-mg tablet of cobimetinib will be administered orally with 240 mL room temperature water.
Treatment B in Period 3: 20 mg oral rabeprazole will be administered once daily for 4 days starting on Day -4.
On Day 1 of treatment period, 20 mg rabeprazole will be administered in fasted state followed by one 20-mg tablet of cobimetinib administration orally with 240 mL room temperature water after at least an 8-hour fast.
There will be a 13-day washout between cobimetinib doses of each period.
|
One 20-mg tablet of cobimetinib will be administered orally with 240 mL room temperature water after at least an 8-hour fast or approximately 30 minutes after starting the standardized FDA high-fat meal.
Andre navne:
Rabeprazole 20 mg will be administered orally once daily for 4 days starting on Day -4 and on Day 1 of the treatment period.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of Cobimetinib
Tidsramme: Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdose
|
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf).
It is obtained from AUC (0 - t) plus AUC (t - inf).
|
Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdose
|
|
Maximum Observed Concentration of Cobimetinib
Tidsramme: Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdose
|
Day 1 at 0 hour (predose), 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 144, and 192 hours postdose
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Isabelle Rooney, M.D., PhD, Genentech, Inc.
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 2011
Primær færdiggørelse (Faktiske)
1. februar 2011
Studieafslutning (Faktiske)
1. februar 2011
Datoer for studieregistrering
Først indsendt
7. januar 2011
Først indsendt, der opfyldte QC-kriterier
13. januar 2011
Først opslået (Skøn)
17. januar 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. maj 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. april 2017
Sidst verificeret
1. april 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MEK4954g
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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