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 |
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.
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
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