- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT03341884
A Study of Ipatasertib in Participants With Mild, Moderate or Severe Hepatic Impairment Compared to Healthy Participants
A Phase 1, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of Ipatasertib in Subjects With Mild, Moderate or Severe Hepatic Impairment Compared to Healthy Subjects
Studie Overzicht
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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Florida
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Miami, Florida, Verenigde Staten, 33014
- Clinical Pharmacology of Miami, Inc.
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Tennessee
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Knoxville, Tennessee, Verenigde Staten, 37920
- New Orleans Center for Clinical Research
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Texas
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San Antonio, Texas, Verenigde Staten, 78215
- American Research Corporation Inc.
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- In good health (except for specific inclusion criteria related to hepatic impairment), as determined by the Investigator, based on no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram, and vital signs
- Females will not be pregnant or breastfeeding, and must be either postmenopausal or agree to use a study-approved method of contraception from the time of signing the informed consent until 30 days after discharge
- Males will either be sterile or agree to use male condom with spermicide from check-in (Day -1) until 90 days following the dose of study drug
Additional Inclusion Criteria for Healthy Subjects Only:
- Liver enzyme tests must be less than or equal to the upper limits of normal
Additional Exclusion Criteria for Hepatic Impaired Subjects Only:
- Hepatic impairment must have a Child-Pugh score of 5 to 6 (mild), 7 to 9 (moderate), or 10 to 15 (severe) and have stable hepatic insufficiency within 1 month prior to Screening
Exclusion Criteria:
- History of ulcerative colitis or stomach or intestinal surgery or resection
- History of unstable diabetes mellitus
- History of alcoholism or drug addiction within 1 year prior to Check-in (Day -1)
- Use of oral, implantable, transdermal, or injectable contraceptives from the time of signing the informed consent (females only) or 10 days prior to Check-in through 45 days after the dose administration
- Poor peripheral venous access
- Receipt of blood products within 2 months prior to check-in
Additional Exclusion Criteria for Healthy Subjects Only:
- Use of any tobacco- or nicotine-containing products within 6 months prior to check-in and during the entire study
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
Additional Exclusion Criteria for Hepatic Impaired Subjects Only:
- Any evidence of progressive liver disease that has worsened or is worsening within 1 month prior to the screening visit
- Participant has shown evidence of hepatorenal syndrome
- Ascites requiring paracentesis
- Participant has required treatment for GI bleeding within 12 months prior to Check-in
- Participant has required additional medication for hepatic encephalopathy within the 12 months (6 months for severe hepatic impairment) prior to check-in
- Total bilirubin levels >6 mg/dL
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Normal Hepatic Function
Participants with normal hepatic function will be administered a single oral dose of ipatasertib (100 mg).
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A single oral dose of 100 mg ipatasertib will be administered.
Andere namen:
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Experimenteel: Mild Hepatic Impairment
Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) will be administered a single dose of ipatasertib (100 mg).
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A single oral dose of 100 mg ipatasertib will be administered.
Andere namen:
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Experimenteel: Moderate Hepatic Impairment
Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) will be administered a single dose of ipatasertib (100 mg).
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A single oral dose of 100 mg ipatasertib will be administered.
Andere namen:
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Experimenteel: Severe Hepatic Impairment
Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) will be administered a single dose of ipatasertib (100 mg).
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A single oral dose of 100 mg ipatasertib will be administered.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Area Under the Plasma Concentration-Time Curve (AUC) from 0 to Infinity (AUC0-inf) of Ipatasertib
Tijdsspanne: up to Day 15
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AUC0-inf is defined as AUC extrapolated from Hour 0 to infinity of ipatasertib in the plasma.
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up to Day 15
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Maximum Observed Plasma Concentration (Cmax) of Ipatasertib
Tijdsspanne: up to Day 15
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Maximum observed concentration of ipatasertib as determined by measuring drug concentration in blood samples over time.
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up to Day 15
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Percentage of Participants with Treatment-Emergent Adverse Events (AE)
Tijdsspanne: up to Day 15
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An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment.
An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.
Preexisting conditions which worsen during a study are also considered as adverse events.
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up to Day 15
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Time to Reach Maximum Observed Concentration (tmax) of Ipatasertib
Tijdsspanne: up to Day 15
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Time from dose administration to observed maximum serum concentration for ipatasertib as determined by measuring drug concentration in blood samples over time.
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up to Day 15
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AUC from 0 to last measurable concentration (AUC0-t)
Tijdsspanne: up to Day 15
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Area under the plasma concentration-time curve from Hour 0 to the last measurable concentration of ipatasertib.
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up to Day 15
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Half-life (t1/2) of Ipatasertib
Tijdsspanne: up to Day 15
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Half-life of ipatasertib is the time elapsed for the drug concentration to decrease by half as determined by measuring drug concentration in blood samples over time.
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up to Day 15
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Apparent Plasma Clearance (CL/F) of Ipatasertib
Tijdsspanne: Up to Day 15
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Apparent clearance (CL/F) of ipatasertib, where CL is clearance and F is bioavailability (relative amount of extravascularly-administered drug that reaches systemic circulation unchanged).
Determined by measuring drug concentration in blood samples over time.
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Up to Day 15
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Apparent Volume of Distribution (V/F) of Ipatasertib
Tijdsspanne: up to Day 15
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Apparent volume of distribution (V/F) during the terminal phase of ipatasertib.
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up to Day 15
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- GP40200
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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