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A Study of Ipatasertib in Participants With Mild, Moderate or Severe Hepatic Impairment Compared to Healthy Participants

15. november 2019 opdateret af: Genentech, Inc.

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

This is a Phase 1 study evaluating the pharmacokinetics, tolerability and safety of a single dose of ipatasertib in participants with mild, moderate or severe hepatic impairment compared to healthy participants.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

29

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Florida
      • Miami, Florida, Forenede Stater, 33014
        • Clinical Pharmacology of Miami, Inc.
    • Tennessee
      • Knoxville, Tennessee, Forenede Stater, 37920
        • New Orleans Center for Clinical Research
    • Texas
      • San Antonio, Texas, Forenede Stater, 78215
        • American Research Corporation Inc.

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 74 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

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: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Normal Hepatic Function
Participants with normal hepatic function will be administered a single oral dose of ipatasertib (100 mg).
A single oral dose of 100 mg ipatasertib will be administered.
Andre navne:
  • GDC-0068
Eksperimentel: 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).
A single oral dose of 100 mg ipatasertib will be administered.
Andre navne:
  • GDC-0068
Eksperimentel: 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).
A single oral dose of 100 mg ipatasertib will be administered.
Andre navne:
  • GDC-0068
Eksperimentel: 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).
A single oral dose of 100 mg ipatasertib will be administered.
Andre navne:
  • GDC-0068

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Area Under the Plasma Concentration-Time Curve (AUC) from 0 to Infinity (AUC0-inf) of Ipatasertib
Tidsramme: up to Day 15
AUC0-inf is defined as AUC extrapolated from Hour 0 to infinity of ipatasertib in the plasma.
up to Day 15
Maximum Observed Plasma Concentration (Cmax) of Ipatasertib
Tidsramme: up to Day 15
Maximum observed concentration of ipatasertib as determined by measuring drug concentration in blood samples over time.
up to Day 15

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants with Treatment-Emergent Adverse Events (AE)
Tidsramme: up to Day 15
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.
up to Day 15
Time to Reach Maximum Observed Concentration (tmax) of Ipatasertib
Tidsramme: up to Day 15
Time from dose administration to observed maximum serum concentration for ipatasertib as determined by measuring drug concentration in blood samples over time.
up to Day 15
AUC from 0 to last measurable concentration (AUC0-t)
Tidsramme: up to Day 15
Area under the plasma concentration-time curve from Hour 0 to the last measurable concentration of ipatasertib.
up to Day 15
Half-life (t1/2) of Ipatasertib
Tidsramme: up to Day 15
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.
up to Day 15
Apparent Plasma Clearance (CL/F) of Ipatasertib
Tidsramme: Up to Day 15
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.
Up to Day 15
Apparent Volume of Distribution (V/F) of Ipatasertib
Tidsramme: up to Day 15
Apparent volume of distribution (V/F) during the terminal phase of ipatasertib.
up to Day 15

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

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 (Faktiske)

9. november 2017

Primær færdiggørelse (Faktiske)

26. juni 2018

Studieafslutning (Faktiske)

26. juni 2018

Datoer for studieregistrering

Først indsendt

9. november 2017

Først indsendt, der opfyldte QC-kriterier

9. november 2017

Først opslået (Faktiske)

14. november 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. november 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. november 2019

Sidst verificeret

1. november 2019

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • GP40200

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Leverinsufficiens

Kliniske forsøg med Ipatasertib

Abonner