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Hepatic ImpairmentPhase 1NCT04887064

Pharmacokinetics of Sotorasib in Healthy Participants and Participants With Moderate or Severe Hepatic Impairment

A Phase 1 study testing Sotorasib in people with Hepatic Impairment, run by Amgen at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main purpose of the study is to evaluate the pharmacokinetics (PK) of a single oral dose of sotorasib administered in participants with moderate or severe hepatic impairment compared to participants with normal hepatic function. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Hepatic Impairment
What is being tested?
Sotorasib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
5 sitesUnited States
Study dates
22 Apr 2021to 9 Mar 2022
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • All Participants
  • Participant has provided informed consent before initiation of any study-specific activities/procedures
  • Participants between 18 and 70 years of age
  • Body mass index between 18 and 38 kg/m^2
  • Females of nonchildbearing potential defined as permanently sterile or postmenopausal
  • Participants with Normal Hepatic Function
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  • In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations
  • Participants with Hepatic Impairment
  • Child-Pugh B or C classification with clinical laboratory values and clinical examination findings
  • Documented medical history of chronic liver disease

Who cannot join

  • All Participants
  • Female participants with a positive pregnancy test at Screening or Check-in
  • Male participants with a pregnant partner or partner planning to become pregnant who are unwilling to practice abstinence or use a condom for 7 days after dosing
  • History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
  • Participant has received a dose of an investigational drug (new chemical entity) within the past 30 days or 5 half-lives, whichever is longer, prior to Check-in
  • Use of any over-the-counter or prescription medications within 30 days or 5 half-lives (whichever is longer)
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  • All herbal medicines vitamins, and supplements consumed by the subject within the 30 days prior to enrollment
  • Alcohol consumption from 48 hours prior to Check-in
  • Positive test for illicit drugs, cotinine (tobacco or nicotine use), and/or alcohol use at Check-in
  • Positive human immunodeficiency virus test at Screening
  • Participants with Normal Hepatic Function
  • Positive hepatitis B or hepatitis C panel at Screening. Subjects whose results are compatible with prior immunity (vaccination or prior infection) may be included
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > upper limit of normal (ULN) at Screening or Check-in
  • Total bilirubin levels > ULN at Screening or Check-in
  • A QT interval corrected for heart rate based on the Fridericia correction (QTcF) interval > 450 msec in male subjects or > 470 msec in female subjects or history/evidence of long QT syndrome at Screening or Check-in, confirmed by calculating the mean of the original value and 2 repeats
  • Participants with Hepatic Impairment
  • Values outside the normal range for liver function tests that are not consistent with their hepatic condition, as determined by the Investigator (or designee)
  • A QTcF interval > 470 msec in male subjects or > 480 msec in female subjects at Screening or Check-in, confirmed by calculating the mean of the original value and 2 repeats
  • Use of a new medication, or a change in dose, for the treatment, or worsening of, hepatic encephalopathy within 30 days prior to Check-in
  • Presence of a portosystemic shunt
  • Evidence of severe ascites

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Clinical Pharmacology Of Miami LLC

    Miami, Florida, 33014

  • Orlando Clinical Research Center

    Orlando, Florida, 32809

  • American Research Corporation

    San Antonio, Texas, 78215

  • Pinnacle Clinical Research - San Antonio

    San Antonio, Texas, 78229

  • Orange County Research Center

    Tustin, California, 92780

Other trials in United States

About this study

Official title: An Open-label Single-dose Study to Evaluate the Pharmacokinetics of Sotorasib in Healthy Subjects and Subjects With Moderate or Severe Hepatic Impairment

The main purpose of the study is to evaluate the pharmacokinetics (PK) of a single oral dose of sotorasib administered in participants with moderate or severe hepatic impairment compared to participants with normal hepatic function.

Being tested
Sotorasib
Keywords
Hepatic Impairment, Sotorasib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SotorasibDrug

    Also called AMG 510

    Sotorasib will be administered as an oral tablet.

Study groups in NCT04887064
Study groupRoleWhat they receive
Normal Hepatic FunctionExperimentalNot described
Receives: Drug: Sotorasib
Moderate Hepatic ImpairmentExperimentalNot described
Receives: Drug: Sotorasib
Severe Hepatic ImpairmentExperimentalNot described
Receives: Drug: Sotorasib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Observed Plasma Concentration (Cmax) of Sotorasib

    Measured: Predose (Hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose following administration of sotorasib on Day 1

  2. Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of Sotorasib

    Measured: Predose (Hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose following administration of sotorasib on Day 1

  3. Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) of Sotorasib

    Measured: Predose (Hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose following administration of sotorasib on Day 1

Secondary outcomes (6)

  1. Number of Participants Who Experienced One or More Treatment Emergent Adverse Events (TEAEs)

    TEAEs were defined as any adverse events (AEs) that started during or after dosing, or started prior to dosing and increased in severity after dosing.

    Any clinically significant changes in clinical laboratory evaluations, 12-lead electrocardiograms (ECGs) and vital signs were also reported as TEAEs.

    Measured: Day 1 to Day 8

  2. Unbound Cmax (Cmax,u) of Sotorasib

    Measured: Predose (Hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose following administration of sotorasib on Day 1

  3. Unbound AUClast (AUClast,u) of Sotorasib

    Measured: Predose (Hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose following administration of sotorasib on Day 1

  4. Unbound AUCinf (AUCinf,u) of Sotorasib

    Measured: Predose (Hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose following administration of sotorasib on Day 1

  5. Unbound Apparent Total Plasma Clearance (CLu/F) of Sotorasib

    Measured: Predose (Hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose following administration of sotorasib on Day 1

  6. Unbound Apparent Volume of Distribution During the Terminal Phase (Vz,u/F) of Sotorasib

    Measured: Predose (Hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose following administration of sotorasib on Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2021
  2. Study start22 Apr 2021
  3. Primary completion9 Mar 2022
  4. Study completion9 Mar 2022

Resources

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
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04887064
Sponsor's protocol ID
20200362
Status last verified
Jan 2023
First submitted
11 May 2021
Last updated
19 Apr 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Sotorasib in people with Hepatic Impairment, run by Amgen at 5 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 10 inclusion and 21 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 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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?

Yes. Results are posted in the registry (first posted 19 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Maximum Observed Plasma Concentration (Cmax) of Sotorasib (time frame: Predose (Hour 0), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose following administration of sotorasib on Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04887064.

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 19 Apr 2024.

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