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

NCT03341884 | Completed Phase 1 FDA Drug

• 1 other identifier: GP40200
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (2)

• Area Under the Plasma Concentration-Time Curve (AUC) from 0 to Infinity (AUC0-inf) of Ipatasertib

  AUC0-inf is defined as AUC extrapolated from Hour 0 to infinity of ipatasertib in the plasma.

  up to Day 15

• Maximum Observed Plasma Concentration (Cmax) of Ipatasertib

  Maximum observed concentration of ipatasertib as determined by measuring drug concentration in blood samples over time.

  up to Day 15

Secondary Outcomes (6)

• Percentage of Participants with Treatment-Emergent Adverse Events (AE)

  up to Day 15

• Time to Reach Maximum Observed Concentration (tmax) of Ipatasertib

  up to Day 15

• AUC from 0 to last measurable concentration (AUC0-t)

  up to Day 15

• Half-life (t1/2) of Ipatasertib

  up to Day 15

• Apparent Plasma Clearance (CL/F) of Ipatasertib

  Up to Day 15

Study Arms (4)

Normal Hepatic Function

EXPERIMENTAL

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

Drug: Ipatasertib

Mild Hepatic Impairment

EXPERIMENTAL

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

Moderate Hepatic Impairment

EXPERIMENTAL

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

Severe Hepatic Impairment

EXPERIMENTAL

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

Interventions

Ipatasertib DRUG

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

Also known as: GDC-0068

Mild Hepatic Impairment; Moderate Hepatic Impairment; Normal Hepatic Function; Severe Hepatic Impairment

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (3)

Clinical Pharmacology of Miami, Inc.

Miami, Florida, 33014, United States

Location

New Orleans Center for Clinical Research

Knoxville, Tennessee, 37920, United States

Location

American Research Corporation Inc.

San Antonio, Texas, 78215, United States

Location

MeSH Terms

Conditions

Hepatic Insufficiency

Interventions

ipatasertib

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: November 14, 2017
• Study Start: November 9, 2017
• Primary Completion: June 26, 2018
• Study Completion: June 26, 2018
• Last Updated: November 18, 2019

Record last verified: 2019-11

Locations

US (3)