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

NCT ID: NCT03341884

Last Updated: 2019-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-09
• Study Completion Date: 2018-06-26

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.

Conditions

Hepatic Insufficiency

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Normal Hepatic Function

Participants with normal hepatic function will be administered a single oral dose of ipatasertib (100 mg).

Group Type: EXPERIMENTAL

Ipatasertib

Intervention Type: DRUG

A single oral dose of 100 mg ipatasertib will be administered.

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).

Group Type: EXPERIMENTAL

Ipatasertib

Intervention Type: DRUG

A single oral dose of 100 mg ipatasertib will be administered.

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).

Group Type: EXPERIMENTAL

Ipatasertib

Intervention Type: DRUG

A single oral dose of 100 mg ipatasertib will be administered.

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).

Group Type: EXPERIMENTAL

Ipatasertib

Intervention Type: DRUG

A single oral dose of 100 mg ipatasertib will be administered.

Interventions

Ipatasertib

A single oral dose of 100 mg ipatasertib will be administered.

Intervention Type: DRUG

Other Intervention Names

GDC-0068

Eligibility Criteria

Inclusion Criteria

• 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

• Liver enzyme tests must be less than or equal to the upper limits of normal

Exclusion Criteria

• 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

• 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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Clinical Pharmacology of Miami, Inc.

Miami, Florida, United States

New Orleans Center for Clinical Research

Knoxville, Tennessee, United States

American Research Corporation Inc.

San Antonio, Texas, United States

Countries

United States

Other Identifiers

GP40200

Identifier Type: -

Identifier Source: org_study_id