Hepatic InsufficiencyPhase 1NCT03341884
A Study of Ipatasertib in Participants With Mild, Moderate or Severe Hepatic Impairment Compared to Healthy Participants
A Phase 1 study testing Ipatasertib in people with Hepatic Insufficiency, run by Genentech, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Insufficiency
- What is being tested?
- Ipatasertib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 3 sitesUnited States
- Study dates
- 9 Nov 2017to 26 Jun 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
New Orleans Center for Clinical Research
Knoxville, Tennessee, 37920
Clinical Pharmacology of Miami, Inc.
Miami, Florida, 33014
American Research Corporation Inc.
San Antonio, Texas, 78215
About this study
Official title: 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.
- Conditions
- Hepatic Insufficiency
- Being tested
- Ipatasertib
- Medical subject headings
- Hepatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IpatasertibDrug
Also called GDC-0068
A single oral dose of 100 mg ipatasertib will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Normal Hepatic Function | Experimental | Participants with normal hepatic function will be administered a single oral dose of ipatasertib (100 mg). Receives: 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). Receives: 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). Receives: 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). Receives: Drug: Ipatasertib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to Day 15
Secondary outcomes (6)
Percentage of Participants with Treatment-Emergent Adverse Events (AE)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Measured: up to Day 15
Time to Reach Maximum Observed Concentration (tmax) of Ipatasertib
Time from dose administration to observed maximum serum concentration for ipatasertib as determined by measuring drug concentration in blood samples over time.
Measured: up to Day 15
AUC from 0 to last measurable concentration (AUC0-t)
Area under the plasma concentration-time curve from Hour 0 to the last measurable concentration of ipatasertib.
Measured: up to Day 15
Half-life (t1/2) of Ipatasertib
Half-life of ipatasertib is the time elapsed for the drug concentration to decrease by half as determined by measuring drug concentration in blood samples over time.
Measured: up to Day 15
Apparent Plasma Clearance (CL/F) of Ipatasertib
Apparent clearance (CL/F) of ipatasertib, where CL is clearance and F is bioavailability (relative amount of extravascularly-administered drug that reaches systemic circulation unchanged). Determined by measuring drug concentration in blood samples over time.
Measured: Up to Day 15
Apparent Volume of Distribution (V/F) of Ipatasertib
Apparent volume of distribution (V/F) during the terminal phase of ipatasertib.
Measured: up to Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start9 Nov 2017
- Primary completion26 Jun 2018
- Study completion26 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic InsufficiencyStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03341884
- Sponsor's protocol ID
- GP40200
- Status last verified
- Nov 2019
- First submitted
- 9 Nov 2017
- Last updated
- 18 Nov 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03341884
- Acronym / sponsor ID
- GP40200
- Conditions
- Hepatic Insufficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Nov 2017 (actual)
- Primary completion
- 26 Jun 2018 (actual)
- Study completion
- 26 Jun 2018 (actual)
- First posted
- 14 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal Hepatic Function | Experimental | Drug: IpatasertibParticipants with normal hepatic function will be administered a single oral dose of ipatasertib (100 mg). |
| Mild Hepatic Impairment | Experimental | Drug: IpatasertibParticipants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) will be administered a single dose of ipatasertib (100 mg). |
| Moderate Hepatic Impairment | Experimental | Drug: IpatasertibParticipants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) will be administered a single dose of ipatasertib (100 mg). |
| Severe Hepatic Impairment | Experimental | Drug: IpatasertibParticipants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) will be administered a single dose of ipatasertib (100 mg). |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- Liver enzyme tests must be less than or equal to the upper limits of normal
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IpatasertibAlso: GDC-0068A single oral dose of 100 mg ipatasertib will be administered. | Drug | Mild Hepatic Impairment, Moderate Hepatic Impairment, Normal Hepatic Function, Severe Hepatic Impairment |
Primary outcome
Area Under the Plasma Concentration-Time Curve (AUC) from 0 to Infinity (AUC0-inf) of Ipatasertib
Time frame: up to Day 15
AUC0-inf is defined as AUC extrapolated from Hour 0 to infinity of ipatasertib in the plasma.
Maximum Observed Plasma Concentration (Cmax) of Ipatasertib
Time frame: up to Day 15
Maximum observed concentration of ipatasertib as determined by measuring drug concentration in blood samples over time.
6 secondary outcomes
Percentage of Participants with Treatment-Emergent Adverse Events (AE)
Time frame: up to Day 15
Time to Reach Maximum Observed Concentration (tmax) of Ipatasertib
Time frame: up to Day 15
AUC from 0 to last measurable concentration (AUC0-t)
Time frame: up to Day 15
Half-life (t1/2) of Ipatasertib
Time frame: up to Day 15
Apparent Plasma Clearance (CL/F) of Ipatasertib
Time frame: Up to Day 15
Apparent Volume of Distribution (V/F) of Ipatasertib
Time frame: up to Day 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ipatasertib in people with Hepatic Insufficiency, run by Genentech, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Plasma Concentration-Time Curve (AUC) from 0 to Infinity (AUC0-inf) of Ipatasertib (time frame: up to Day 15). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2019.