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



Status:Completed
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 74
Updated:11/1/2018
Start Date:November 9, 2017
End Date:June 26, 2018

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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.


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
We found this trial at
3
sites
Knoxville, Tennessee 37920
777
mi
from
Knoxville, TN
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Miami, Florida 33014
1310
mi
from
Miami, FL
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San Antonio, Texas 78215
575
mi
from
San Antonio, TX
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