A Phase 1 interventional study of Ipatasertib in Hepatic Insufficiency, sponsored by Genentech, Inc.. Completed at 3 sites in United States. Open to participants aged 18 Years to 74 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-18.
Sponsored by Genentech, Inc. (part of Hoffmann-La Roche) · Phase 1, Interventional, and Treatment
Among 52 studies in Hepatic Insufficiency with a site in United States — 3 open to participants now, 4 under way, none of them phase 3. Hepatic Insufficiency · United States.
Among the 52 studies in Hepatic Insufficiency with a site in United States, this one is the 21st largest by enrollment of the 48 interventional ones that give a count, is one of 3 that started in 2017, is one of 42 in phase 1, and was the 28th registered.
113 studies on the registry are indexed under Hepatic Insufficiency; 15 are open to participants now.
Browse Hepatic Insufficiency studies →3 of the 52 studies in Hepatic Insufficiency with a site in United States are open now. Recruiting first, the newest first:
Pfizer · Sites in United States
Ages 18+ · Healthy volunteers
Incyte Corporation · Sites in United States
Ages 18–80
Eli Lilly and Company · Sites in United States, Hungary
Ages 18–85 · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 9 Hepatic Insufficiency studies recruiting now, 3 set no upper age limit and 3 stop at 75 or younger; 1 takes children under 18; 4 take healthy volunteers.
This study: 18 Years to 74 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
52 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 3 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 29 is close to the median of 29 across 100 interventional studies indexed under Hepatic Insufficiency.
Median enrollment 28 across the 48 interventional studies, 28 across the 3 observational. Of the 47 that completed or were terminated, 16 (34%) have results posted.
This tab as a report to print or save as PDF → With an account.
47 of 52 have an industry lead sponsor. The 10 most frequent:
Genentech, Inc. is the lead sponsor of 517 studies on the registry; 20 are open to participants now.
Of its 95 completed or terminated interventional studies of FDA-regulated products, 52 (55%) have results posted.
Hoffmann-La Roche has 2 studies filed under Hepatic Insufficiency — fewer than ten, so there is no comparison to draw.
3 of the studies in Hepatic Insufficiency with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07401862Eli Lilly and CompanyA Study of Eloralintide (LY3841136) in Participants With Different Levels of Liver Damage and in Participants With Healthy Livers. | 2027-03 |
| NCT07559474Incyte CorporationA Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult Participants With Moderate or Severe Hepatic Impairment | 2027-04-13 |
| NCT07677358PfizerA Study to Learn How the Study Medicine Called Atirmociclib is Handled by the Body in People With Normal Liver Function and Different Levels of Liver Disease | 2027-08-14 |
Add all 3 to your calendar (.ics) → With an account.
Among the 52 studies in Hepatic Insufficiency with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Additional Inclusion Criteria for Healthy Subjects Only:
Additional Exclusion Criteria for Hepatic Impaired Subjects Only:
Exclusion Criteria:
Additional Exclusion Criteria for Healthy Subjects Only:
Additional Exclusion Criteria for Hepatic Impaired Subjects Only:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with normal hepatic function will be administered a single oral dose of ipatasertib (100 mg).
Drug: Ipatasertib
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
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
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
A single oral dose of 100 mg ipatasertib will be administered.
Also known as: GDC-0068
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.
Time frame: 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.
Time frame: up to Day 15
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to Day 15
Apparent Volume of Distribution (V/F) of Ipatasertib
Apparent volume of distribution (V/F) during the terminal phase of ipatasertib.
Time frame: up to Day 15
Ran from Nov 2017 to primary completion in Jun 2018, 7 months.
Of 38 industry-sponsored phase 1 interventional studies under Hepatic Insufficiency, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 17. This study's 7 months is below that.
Counting every sponsor, half of 41 studies reached it within 8 months; a quarter within 5 and three quarters within 17.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ipatasertib