Status:
COMPLETED
A Study of Ipatasertib in Participants With Mild, Moderate or Severe Hepatic Impairment Compared to Healthy Participants
Lead Sponsor:
Genentech, Inc.
Conditions:
Hepatic Insufficiency
Eligibility:
All Genders
18-74 years
Phase:
PHASE1
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 pa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 9 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 26 2018
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT03341884
Start Date
November 9 2017
End Date
June 26 2018
Last Update
November 18 2019
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinical Pharmacology of Miami, Inc.
Miami, Florida, United States, 33014
2
New Orleans Center for Clinical Research
Knoxville, Tennessee, United States, 37920
3
American Research Corporation Inc.
San Antonio, Texas, United States, 78215