Hepatic ImpairmentPhase 1NCT04573582

Pharmacokinetics of Enasidenib (CC-90007) in Participants With Mild, Moderate and Severe Hepatic Impairment

A Phase 1 study testing Enasidenib in people with Hepatic Impairment, run by Celgene at 3 sites in United States.

Completed

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

Trial summary

This is a multi-center, open-label study to assess the PK of single 100 mg oral doses of enasidenib (CC-90007) in subjects with mild, moderate, and severe hepatic impairment (HI), and in matched healthy control subjects with normal hepatic function. Read more about this study

Who is it for?: Ages 40 to 75 years
Conditions the study is for: Hepatic Impairment
What is being tested?: Enasidenib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 3 sitesUnited States
Study dates: 13 Nov 2020to 8 Mar 2023
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 40 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Inclusion Criteria for all subjects (Groups A, B, C, D) Each subject must satisfy all of the following criteria to be enrolled in the study.
Subject must understand and voluntarily sign an informed consent form (ICF) prior to any study-related assessments/procedures being conducted.
Subject is able to communicate with the Investigator, understand and comply with the requirements of the study, and agree to adhere to restrictions and examination schedules and other protocol requirements.
Subject is willing and able to adhere to the study visit schedule and other protocol requirements, including the restrictions.
4. Male, or non-pregnant and non-nursing female between ≥ 40 and ≤ 75 years of age the time of signing the ICF..
Body mass index (BMI) ≥ 18 and ≤ 40 kg/m2 at screening.

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Supine systolic blood pressure (BP): 90 to 160 mmHg, supine diastolic BP:50 to 100 mmHg, and pulse rate: 40 to 100 bpm.
Subject is afebrile.
Female subjects NOT of childbearing potential must:
Have been surgically sterilized at least 6 months before screening, or be naturally postmenopausal.
Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline Visits. While receiving IP and for at least 2 months after taking the last dose of IP, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options.
Male subjects must:
Practice true abstinence or
agree to use a barrier method of birth control during sexual contact with a pregnant female or FCBP while participating in the study, during dose interruptions, and for at least 2 months after the last dose of IP, even if he has undergone a successful vasectomy.
Inclusion Criteria for Subjects with mild, moderate, or severe hepatic impairment (Groups A-C)
Each subject with mild, moderate, or severe hepatic impairment must also meet all the applicable criteria listed below for study entry:
Subject has moderate or severe hepatic impairment or cirrhosis due to chronic hepatic disease and/or prior alcohol use.
Subject has mild (Group A), moderate (Group B), or severe (Group C) hepatic impairment as defined by Child-Pugh Score.
Group A subjects must have mild hepatic impairment and are required to have documentary confirmation of the diagnosis of cirrhosis made by biopsy, laparoscopy, or imaging study with a Child-Pugh score of < 7, at screening.
Group B subjects must have moderate hepatic impairment and are required to have documentary confirmation of the diagnosis of cirrhosis made by biopsy, laparoscopy, or imaging study with a Child-Pugh score of ≥ 7 to ≤ 9, at screening.
Group C subjects must have severe hepatic impairment. If biopsy or laparoscopy is not performed prior to screening, subject can be included only if they have chronic liver disease and objective evidence of portal hypertension (ascites diagnosis by imaging or varices), or current medication for consequences of portal hypertension.
In either case a Child-Pugh score of ≥ 10 to ≤ 14 at screening is required. Subjects should be enrolled into the group corresponding to the Child-Pugh classification score that most accurately reflects the most severe hepatic disease classification within the past 6 months (based on past medical history or physical examination observation).
Must be medically stable for at least 1 month before screening with clinically acceptable medical history, PE, clinical laboratory tests, vital signs, and 12-lead ECGs consistent with the underlying stable mild (Group A), moderate (Group B), or severe (Group C) hepatic impairment condition, as judged by the Investigator.
Subject has a normal or clinically acceptable 12-lead ECG at screening. In addition:
Subject (male or female) has a QTcF value ≤ 500 msec at screening.
Must be stable on a concomitant medication regimen before dosing with study drug).
Subjects may be treated with diuretics for ascites; however, subjects with severe ascites at time of enrollment may only be included at the discretion of the investigator with agreement of the Sponsor.
Subjects may have a history of encephalopathy; however, they must be on stable treatment for at least 1 month prior to screening, and must not have had an acute encephalopathic episode in the 1 months prior to screening.
Each matched healthy subject must also meet all applicable criteria listed below for study entry:
Subject must be free of any clinically significant disease that would interfere with the study evaluations.
Subject must have liver-related laboratory test results within the respective reference ranges or with clinically insignificant excursions therefrom as agreed by the Investigator.
Subject in Group D must match at least one subject in Groups A-C, as needed with respect to sex, age (± 10 years), and weight (± 30 pounds).
Subject must be in good health as determined by past medical history, PE, vital signs, ECG, and clinical laboratory safety tests. Clinical laboratory safety tests (ie, hematology, chemistry, and urinalysis) and 12-lead ECGs must be within normal limits or clinically acceptable as judged by the Investigator.
Subject has a normal or clinically acceptable 12-lead ECG at screening. In addition:
If male, subject has a QTcF value ≤ 450 msec at screening;
If female, subject has a QTcF value ≤ 470 msec at screening.

Who cannot join

Exclusion Criteria for all Subjects (Group A, B, C, and D) The presence of any of the following will exclude a subject from enrollment.
Subject has any condition or circumstance that prevents the subject from understanding and signing the ICF.
Subject has any condition that places the subject at an unacceptable risk from participating in the study or would confound the ability to interpret data from the study.
Subject has any significant medical condition or psychiatric illness that would prevent the subject from participating in the study at Investigator discretion.
Subject has any surgical or medical condition(s) possibly affecting drug absorption, distribution, metabolism, excretion, eg, bariatric procedure. Subjects with cholecystectomy and appendectomy may be included.
Subject has an estimated creatinine clearance < 60 mL/min as calculated using the Cockcroft-Gault formula- at screening and baseline (Day -1).

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Subject is pregnant or is breastfeeding.
Subject participated in Study CC-90007-CP-003.
Subject donated blood or plasma within 2 weeks before dose administration to a blood bank or blood donation center.
Subject has a history of alcohol abuse within 6 months before the first dose administration, or positive alcohol screen.
Subject has a history of drug abuse within 6 months before the first dose administration, or positive drug screen that is not consistent with the patient's prescribed medication and or/medical history.
Subject is known to have active serum hepatitis, or have a positive result to the test for Human immunodeficiency virus (HIV) antibodies at screening.
Chronic or resolved Hepatitis B or Hepatitis C are acceptable only if sequelae are limited to hepatic involvement and its consequent comorbidities. (ie, Vasculitis, clinically significant cryoglobulinemia, etc. are unacceptable.)
Subject was exposed to an investigational drug within 30 days before dosing, or 5 half-lives of that investigational drug, if known (whichever is longer).
Subject used approved medications or herbal medicines that are moderate or strong cytochrome P450 (CYP)1A2, CYP2B6 CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4/5 inducers and/or inhibitors (including St. John's wort) within 14 days or 5 half-lives of screening, whichever is longer.
Subject will have consumed Seville oranges, grapefruit or grapefruit juice and/or pomelos, exotic citrus fruits, or grapefruit hybrids within 14 days or 5 half-lives of dosing, whichever is longer.
Subject smokes more than 10 cigarettes per day, or the equivalent in other tobacco products (self-reported).
Subject has a history of multiple drug allergies or drug-related anaphylaxis.
Subject has received live vaccination (excluding seasonal flu vaccination) within 90 days of dosing.
Subject is part of the staff personnel or a family member of the investigational study staff.
Subject is, for any reason, deemed by the investigator to be inappropriate for this study, including a subject who is unable to communicate or to cooperate with the investigator or the clinical staff.
Subject has had a Transjugular intrahepatic portosystemic shunt (TIPS) procedure.
Positive SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) test or signs/symptoms of COVID-19 (Coronavirus Disease 2019) infection.
Participants currently in other interventional trials, including those for COVID-19, may not participate in BMS clinical trials until the protocol specific washout period is achieved. If a study participant has received an investigational COVID-19 vaccine or other investigational product designed to treat or prevent COVID-19 prior to screening, enrollment must be delayed until the biologic impact of the vaccine or investigational product is stabilized, as determined by discussion between the Investigator and the Medical Monitor.
Exclusion Criteria for Subjects with Hepatic Impairment (Group A, B, and C) The presence of any of the following will exclude a hepatically impaired subject from enrollment.
Subject has any unstable medical condition occurring within 3 months prior to signing the ICF (excluding hepatic impairment and associated comorbidities per Investigator discretion).
Subject has any serious medical condition (excluding hepatic impairment and related complications), clinically significant laboratory abnormality not related to hepatic impairment and related complications, or psychiatric illness that would prevent the subject from signing the ICF and participating in the study per Investigator discretion.
Subject has hepatic encephalopathy with time- or place- disorientation, somnolence, stupor, rigidity, coma, no personality/behavior, rigidity, or hyperactive reflexes - or has had such within 1 month of screening.
Subject has a history of incipient/planned liver transplantation within 6 months of screening or has received a liver transplant.
Subject has a history of hepatorenal syndrome or hemolysis.
Exclusion Criteria for a Matched Healthy Subject (Group D) The presence of any of the following will exclude a healthy match subject from enrollment.
Subject has any clinically significant laboratory abnormality that in the opinion of the Investigator, is considered to prevent the subject from safely completing the study.
Subject has any unstable clinically significant illness within 3 months prior to the study.
Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
Positive testing for any active hepatitis, or history of Hepatitis B or C.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Volunteer Research Group and New Orleans Center for Clinical Research - Knoxville
Knoxville, Tennessee, 37920
Local Institution - 002
Miami, Florida, 33136
Local Institution - 003
Orlando, Florida, 32809

Other trials in United States

About this study

Official title: A Phase 1 Open-Label Single-Dose Study to Assess the Pharmacokinetics of Enasidenib (CC 90007) in Subjects With Mild, Moderate and Severe Hepatic Impairment

Degrees of hepatic impairment will be determined during screening by the subject's score according to Pugh's Modification of Child's Classification of Severity of Liver Disease.

Subjects will be enrolled in 4 Groups as follows:

Group A: Approximately 8 subjects with mild hepatic impairment (with a Child-Pugh score of < 7) will be enrolled in Group A.
Group B: Approximately 8 subjects with moderate hepatic impairment (with a Child-Pugh score of ≥ 7 to ≤ 9) will be enrolled in Group B.
Group C: Approximately 8 subjects with severe hepatic impairment (with a Child-Pugh score of ≥ 10 to ≤ 15) will be enrolled in Group C.
Group D: Approximately 8-24 healthy subjects with normal hepatic function will be enrolled in Group D. Subjects in Group D will be matched to subjects in Groups A-C with respect to sex, age (± 10 years), and weight (± 30 pounds). More than 1 subject with differing degrees of HI can be matched to a single control; however, all subjects with HI must be matched to at least 1 healthy match subject.

Conditions: Hepatic Impairment
Being tested: Enasidenib
Keywords: Hepatic Impairment, CC-90007, Phase 1, Enasidenib

What participants receive

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

EnasidenibDrug
Also called AG-221, AG-221 mesylate, AGI-12910, AGI-12910 mesylate
100 mg enasidenib (CC-90007)

Study groups in NCT04573582
Study group	Role	What they receive
Enasidenib (CC-90007) tablet	Experimental	Participants will receive one 100 mg enasidenib (CC-90007) tablet the morning of Day 1 which will be administered in the fasted state. Receives: Drug: Enasidenib

What is being measured

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

Pharmacokinetics - Cmax (CC-90007)
Estimation of maximum observed plasma concentration
Measured: Up to Day 1
Pharmacokinetics - AUC0-∞ (CC-90007)
Estimation of AUC from time zero extrapolated to infinity
Measured: Up to Day 36
Pharmacokinetics - AUC0-t (CC-90007)
Estimation of AUC from time zero extrapolated to last time point
Measured: Up to Day 36
Pharmacokinetics - Tmax (CC-90007)
Time to reach Cmax
Measured: Up to Day 1

Secondary outcomes (5)

Pharmacokinetics - Cmax (AGI-16903)
Estimation of maximum observed plasma concentration
Measured: Up to Day 1
Pharmacokinetics - AUC0-∞ (AGI-16903)
Estimation of AUC from time zero extrapolated to infinity
Measured: Up to Day 36
Pharmacokinetics - AUC0-t (AGI-16903)
Estimation of AUC from time zero extrapolated to last time point
Measured: Up to Day 36
Pharmacokinetics - Tmax (AGI-16903)
Time to reach Cmax
Measured: Up to Day 1
Adverse Events (AEs)
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
Measured: From the time the ICF is signed until Day 36 (+/- 2 days) or within 28 days after the last dose of IP, whichever time frame is longer

Timeline

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

13 Nov 20208 Mar 2023

First posted5 Oct 2020
Study start13 Nov 2020
Primary completion8 Mar 2023
Study completion8 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
More trials run by CelgeneThe 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04573582
Sponsor's protocol ID: CC-90007-CP-007
Other IDs: U1111-1257-6808
Status last verified: Jul 2024
First submitted: 28 Sep 2020
Last updated: 15 Jul 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Open-Label Single-Dose Study to Assess the Pharmacokinetics of Enasidenib (CC 90007) in Subjects With Mild, Moderate and Severe Hepatic Impairment
ClinicalTrials.gov ID: NCT04573582
Acronym / sponsor ID: CC-90007-CP-007
Conditions: Hepatic Impairment
Keywords: Hepatic Impairment, CC-90007, Phase 1, Enasidenib
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: CelgeneIndustry (pharma, biotech, devices)
Study start: 13 Nov 2020 (actual)
Primary completion: 8 Mar 2023 (actual)
Study completion: 8 Mar 2023 (actual)
First posted: 5 Oct 2020 (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.

Degrees of hepatic impairment will be determined during screening by the subject's score according to Pugh's Modification of Child's Classification of Severity of Liver Disease.

Subjects will be enrolled in 4 Groups as follows:

Group A: Approximately 8 subjects with mild hepatic impairment (with a Child-Pugh score of < 7) will be enrolled in Group A.
Group B: Approximately 8 subjects with moderate hepatic impairment (with a Child-Pugh score of ≥ 7 to ≤ 9) will be enrolled in Group B.
Group C: Approximately 8 subjects with severe hepatic impairment (with a Child-Pugh score of ≥ 10 to ≤ 15) will be enrolled in Group C.
Group D: Approximately 8-24 healthy subjects with normal hepatic function will be enrolled in Group D. Subjects in Group D will be matched to subjects in Groups A-C with respect to sex, age (± 10 years), and weight (± 30 pounds). More than 1 subject with differing degrees of HI can be matched to a single control; however, all subjects with HI must be matched to at least 1 healthy match subject.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Enasidenib (CC-90007) tablet	Experimental	Drug: EnasidenibParticipants will receive one 100 mg enasidenib (CC-90007) tablet the morning of Day 1 which will be administered in the fasted state.

Who may qualify

Ages: 40 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (36 listed)

Inclusion Criteria for all subjects (Groups A, B, C, D) Each subject must satisfy all of the following criteria to be enrolled in the study.
Subject must understand and voluntarily sign an informed consent form (ICF) prior to any study-related assessments/procedures being conducted.
Subject is able to communicate with the Investigator, understand and comply with the requirements of the study, and agree to adhere to restrictions and examination schedules and other protocol requirements.
Subject is willing and able to adhere to the study visit schedule and other protocol requirements, including the restrictions.
4. Male, or non-pregnant and non-nursing female between ≥ 40 and ≤ 75 years of age the time of signing the ICF..

Key exclusion criteria (35 listed)

Exclusion Criteria for all Subjects (Group A, B, C, and D) The presence of any of the following will exclude a subject from enrollment.
Subject has any condition or circumstance that prevents the subject from understanding and signing the ICF.
Subject has any condition that places the subject at an unacceptable risk from participating in the study or would confound the ability to interpret data from the study.
Subject has any significant medical condition or psychiatric illness that would prevent the subject from participating in the study at Investigator discretion.
Subject has any surgical or medical condition(s) possibly affecting drug absorption, distribution, metabolism, excretion, eg, bariatric procedure. Subjects with cholecystectomy and appendectomy may be included.

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
EnasidenibAlso: AG-221, AG-221 mesylate, AGI-12910, AGI-12910 mesylate100 mg enasidenib (CC-90007)	Drug	Enasidenib (CC-90007) tablet

Primary outcome

Pharmacokinetics - Cmax (CC-90007)
Time frame: Up to Day 1
Estimation of maximum observed plasma concentration
Pharmacokinetics - AUC0-∞ (CC-90007)
Time frame: Up to Day 36
Estimation of AUC from time zero extrapolated to infinity
Pharmacokinetics - AUC0-t (CC-90007)
Time frame: Up to Day 36
Estimation of AUC from time zero extrapolated to last time point
Pharmacokinetics - Tmax (CC-90007)
Time frame: Up to Day 1
Time to reach Cmax

5 secondary outcomes

Pharmacokinetics - Cmax (AGI-16903)
Time frame: Up to Day 1
Pharmacokinetics - AUC0-∞ (AGI-16903)
Time frame: Up to Day 36
Pharmacokinetics - AUC0-t (AGI-16903)
Time frame: Up to Day 36
Pharmacokinetics - Tmax (AGI-16903)
Time frame: Up to Day 1
Adverse Events (AEs)
Time frame: From the time the ICF is signed until Day 36 (+/- 2 days) or within 28 days after the last dose of IP, whichever time frame is longer

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 15 Jul 2024.
BMS Clinical Trial InformationLink provided by the sponsor.
BMS Clinical Trial Patient RecruitingLink provided by the sponsor.

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RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
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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.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

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 Enasidenib in people with Hepatic Impairment, run by Celgene 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 36 inclusion and 35 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 15 Jul 2024. 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?

Pharmacokinetics - Cmax (CC-90007) (time frame: Up to Day 1). The study lists 4 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 NCT04573582.

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 15 Jul 2024.