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

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ClinicalTrials.gov Identifier: NCT03341884
Recruitment Status : Completed
First Posted : November 14, 2017
Last Update Posted : October 30, 2018
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatic Insufficiency Drug: Ipatasertib Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 9, 2017
Actual Primary Completion Date : June 26, 2018
Actual Study Completion Date : June 26, 2018

Arm Intervention/treatment
Experimental: Normal Hepatic Function
Participants with normal hepatic function will be administered a single oral dose of ipatasertib (100 mg).
Drug: Ipatasertib
A single oral dose of 100 mg ipatasertib will be administered.
Other Name: GDC-0068

Experimental: 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).
Drug: Ipatasertib
A single oral dose of 100 mg ipatasertib will be administered.
Other Name: GDC-0068

Experimental: 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).
Drug: Ipatasertib
A single oral dose of 100 mg ipatasertib will be administered.
Other Name: GDC-0068

Experimental: 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).
Drug: Ipatasertib
A single oral dose of 100 mg ipatasertib will be administered.
Other Name: GDC-0068




Primary Outcome Measures :
  1. Area Under the Plasma Concentration-Time Curve (AUC) from 0 to Infinity (AUC0-inf) of Ipatasertib [ Time Frame: up to Day 15 ]
    AUC0-inf is defined as AUC extrapolated from Hour 0 to infinity of ipatasertib in the plasma.

  2. Maximum Observed Plasma Concentration (Cmax) of Ipatasertib [ Time Frame: up to Day 15 ]
    Maximum observed concentration of ipatasertib as determined by measuring drug concentration in blood samples over time.


Secondary Outcome Measures :
  1. Percentage of Participants with Treatment-Emergent Adverse Events (AE) [ Time Frame: 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.

  2. Time to Reach Maximum Observed Concentration (tmax) of Ipatasertib [ Time Frame: 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.

  3. AUC from 0 to last measurable concentration (AUC0-t) [ Time Frame: up to Day 15 ]
    Area under the plasma concentration-time curve from Hour 0 to the last measurable concentration of ipatasertib.

  4. Half-life (t1/2) of Ipatasertib [ Time Frame: 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.

  5. Apparent Plasma Clearance (CL/F) of Ipatasertib [ Time Frame: 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.

  6. Apparent Volume of Distribution (V/F) of Ipatasertib [ Time Frame: up to Day 15 ]
    Apparent volume of distribution (V/F) during the terminal phase of ipatasertib.



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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03341884


Locations
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United States, Florida
Clinical Pharmacology of Miami, Inc.
Miami, Florida, United States, 33014
United States, Tennessee
New Orleans Center for Clinical Research
Knoxville, Tennessee, United States, 37920
United States, Texas
American Research Corporation Inc.
San Antonio, Texas, United States, 78215
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT03341884     History of Changes
Other Study ID Numbers: GP40200
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: October 30, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hepatic Insufficiency
Liver Failure
Liver Diseases
Digestive System Diseases