Hepatic ImpairmentPhase 1NCT03742882
A Study to Assess the Pharmacokinetics of CC-90001 in Subjects With Mild, Moderate, and Severe Hepatic Impairment Compared With Healthy Subjects
A Phase 1 study testing CC-90001 in people with Hepatic Impairment, run by Celgene at 4 sites in United States.
Trial summary
This is a multicenter, open-label study to assess the PK of a single 200 mg oral dose of CC-90001 in subjects with mild, moderate, and severe hepatic impairment, and in matched healthy control subjects 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?
- CC-90001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesUnited States
- Study dates
- 6 Dec 2018to 10 Jun 2019
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject must understand and voluntarily sign an Informed Consent Form (ICF) prior to any study-related assessments/procedures being conducted.
- Subject is willing and able to adhere to the study visit schedule and other protocol requirements, including the restrictions.
- Subject is male, or non-pregnant and non-nursing female between ≥ 18 and ≤ 70 years of age at the time of signing the ICF.
- Subject has Body mass index (BMI) ≥ 18 and ≤ 40 kg/m2 at screening.
- Female subjects NOT of childbearing potential must:
- Have been surgically sterilized (hysterectomy or bilateral oophorectomy; proper documentation required) at least 6 months before Screening, or postmenopausal (defined as 24 consecutive months without menses before Screening, with a follicle-stimulating hormone [FSH] level in the postmenopausal range according to the laboratory used at Screening); FSH to be performed at the discretion of the Investigator in consultation with the Medical Monitor.
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- Females of childbearing potential (FCBP)1 must have a negative pregnancy test at the Screening and Baseline Visits. While receiving Investigational Product (IP) and for at least 28 days after taking the dose of IP, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below: Option 1: One highly effective method (e.g., hormonal contraception [oral, injection, implant, transdermal patch, vaginal ring]; intrauterine device; tubal ligation; or partner's vasectomy) and one additional form (latex condom or any nonlatex condom not made of natural [animal] membrane [eg, polyurethane], diaphragm, sponge).
- OR Option 2: Male or female condom PLUS 1 additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.
- Male subjects must:
- Practice true abstinence2 (which must be reviewed on a monthly basis and source documented) or agree to use a barrier method of birth control (condoms not made out of natural [animal] membrane [latex condoms were recommended]) during sexual contact with a pregnant female or female of FCBP while participating in the study, during dose interruptions, and for at least 28 days after the dose of investigational product, even if he has undergone a successful vasectomy.
- Subject has clinical laboratory safety test results that are within normal limits or acceptable to the Investigator.
- Subject is afebrile (febrile is defined as ≥ 38°C or 100.3°F), with supine systolic blood pressure ≥ 90 and ≤ 160 mm Hg, supine diastolic blood pressure ≥ 50 and ≤ 100 mm Hg, and pulse rate ≥ 40 and ≤ 100 beats per minute at Screening.
Who cannot join
- The presence of any of the following will exclude a subject from enrollment:
- Subject has any significant and relevant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study at the Investigator's discretion.
- Subject has any condition that places the subject at an unacceptable risk if he or she were to participate in the study.
- Subject has any condition that confounds the ability to interpret data from the study.
- Subject is pregnant or breastfeeding.
- Subject was exposed to an investigational drug (new chemical entity) within 30 days preceding the first dose administration, or 5 half-lives of that investigational drug, if known (whichever was longer).
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- Subject has used moderate or strong CYP3A4/5 inducers and/or inhibitors (including St. John's wort) within 30 days prior to dosing. The Indiana University P450 Drug Interactions Flockhart Table™ may be consulted for a list of such medications (http://medicine.iupui.edu/clinpharm/ddis/main-table).
- Subject has any surgical or medical condition(s) possibly affecting drug absorption, distribution, metabolism, and excretion, eg, bariatric procedure. Subjects with appendectomy and cholecystectomy may be included.
- Subject has an estimated creatinine clearance < 60 mL/min as calculated using the Cockcroft-Gault formula.
- Subject has donated blood or plasma within 2 weeks before dose administration to a blood bank or blood donation center.
- Subject has a history of drug abuse (as defined by the current version of the Diagnostic and Statistical Manual) within 2 years before dose administration, or positive drug screening test reflecting consumption of illicit drugs unless positive drug screen is due to prescription drug use that is approved by the Investigator and the Medical Monitor.
- Subject has a history of alcohol abuse (as defined by the current version of the Diagnostic and Statistical Manual) within 1 year before dose administration, or a positive alcohol screen.
- Subject has had 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 globulinemia, etc. are unacceptable).
- Subject smokes more than 10 cigarettes per day, or the equivalent in other tobacco products (self-reported).
- Subject has received live vaccination (excluding seasonal flu vaccination) within 30 days of dosing.
- Subject is part of the clinical staff personnel or a family member of the study site 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Volunteer Research Group and New Orleans Center for Clinical Research - Knoxville
Knoxville, Tennessee, 37920
University of Miami Miller School of Medicine
Miami, Florida, 33136
Orlando Clinical Research Center OCRC
Orlando, Florida, 32809
The Texas Liver Institute
San Antonio, Texas, 78215
About this study
Official title: A Phase 1, Open-label, Multicenter, Single-dose Study to Assess the Pharmacokinetics of CC-90001 in Subjects With Mild, Moderate, and Severe Hepatic Impairment Compared With Healthy Subjects
This is a multicenter, open-label study to assess the PK of a single 200 mg oral dose of CC-90001 in subjects with mild, moderate, and severe hepatic impairment, and in matched healthy control subjects with normal hepatic function.
Degrees of hepatic impairment will be determined during screening by the subject's score according to Child-Pugh Classification Criteria.
Read the detailed description
Subjects will be enrolled in Groups 1 through 5 as follows:
- Group 1: Approximately 6 to 8 male or female subjects with mild hepatic impairment (with a Child-Pugh score of ≥ 5 to ≤ 6) will be enrolled in Group 1.
- Group 2: Approximately 6 to 8 male or female subjects with moderate hepatic impairment (with a Child-Pugh score of ≥ 7 to ≤ 9) will be enrolled in Group 2.
- Group 3: Approximately 6 to 8 healthy male or female subjects with normal hepatic function will be enrolled in Group 3. Subjects in Group 3 will be matched to subjects in Group 2 with respect to sex, age (± 10 years), and weight (± 10% body mass index [BMI]). Group 3 will also serve as the control group for Group 1.
- Group 4: Approximately 6 to 8 male or female subjects with severe hepatic impairment (with a Child-Pugh score of ≥ 10 to ≤ 13) will be enrolled in Group 4.
- Group 5: Approximately 6 to 8 healthy male or female subjects with normal hepatic function will be enrolled in Group 5. Subjects in Group 5 will be matched to subjects in Group 4 with respect to sex, age (± 10 years), and weight (± 10% BMI).
This study employs a staged design as follows:
- Subjects with mild or moderate hepatic impairment and matching healthy subjects with normal hepatic function (Groups 1 through 3) will be enrolled concomitantly.
- At least 4 subjects with mild or moderate hepatic impairment must demonstrate satisfactory safety and tolerability for up to 4 days after dosing before subjects with severe hepatic impairment may be dosed.
- Two subjects with severe hepatic impairment must demonstrate satisfactory safety and tolerability for up to 4 days after dosing before the remaining subjects with severe hepatic impairment may be dosed.
- Conditions
- Hepatic Impairment
- Being tested
- CC-90001
- Keywords
- CC-90001, Pharmacokinetics, Hepatic Impairment, Healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-90001Drug
CC-90001
| Study group | Role | What they receive |
|---|---|---|
| Administration of CC-90001 | Experimental | Single oral dose of 200 mg of CC-90001 Receives: Drug: CC-90001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic- AUC0-t
Estimation of AUC calculated from time zero to the last measured time point
Measured: UP to approximately 7 Days
Pharmacokinetic- AUC0-∞
Estimation of AUC calculated from time zero to infinity
Measured: UP to approximately 7 Days
Pharmacokinetic- Cmax
Estimation of observed maximum plasma concentration
Measured: UP to approximately Day 1
Pharmacokinetic- Tmax
Estimation of time to Cmax
Measured: UP to approximately Day 1
Pharmacokinetic- t1/2
Estimation of terminal elimination half-life
Measured: Up to approximately 7 days
Pharmacokinetic- CL/F
Estimation of apparent clearance of drug from plasma after extravascular administration
Measured: Up to approximately 7 days
Pharmacokinetic- Vz/F
Estimation of apparent volume of distribution during the terminal phase
Measured: Up to approximately 7 days
Secondary outcomes (1)
Adverse Events (AEs)
Number of subjects with adverse event
Measured: From enrollment until at least 28 days after completion of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start6 Dec 2018
- Primary completion10 Jun 2019
- Study completion10 Jun 2019
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)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kofi Mensah, MD, PhD, Study director, Celgene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03742882
- Sponsor's protocol ID
- CC-90001-CP-005
- Other IDs
- U1111-1223-7431
- Status last verified
- Jul 2020
- First submitted
- 13 Nov 2018
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Multicenter, Single-dose Study to Assess the Pharmacokinetics of CC-90001 in Subjects With Mild, Moderate, and Severe Hepatic Impairment Compared With Healthy Subjects
- ClinicalTrials.gov ID
- NCT03742882
- Acronym / sponsor ID
- CC-90001-CP-005
- Conditions
- Hepatic Impairment
- Keywords
- CC-90001, Pharmacokinetics, Hepatic Impairment, Healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2018 (actual)
- Primary completion
- 10 Jun 2019 (actual)
- Study completion
- 10 Jun 2019 (actual)
- First posted
- 15 Nov 2018 (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 multicenter, open-label study to assess the PK of a single 200 mg oral dose of CC-90001 in subjects with mild, moderate, and severe hepatic impairment, and in matched healthy control subjects with normal hepatic function.
Degrees of hepatic impairment will be determined during screening by the subject's score according to Child-Pugh Classification Criteria.
Detailed description
Subjects will be enrolled in Groups 1 through 5 as follows:
- Group 1: Approximately 6 to 8 male or female subjects with mild hepatic impairment (with a Child-Pugh score of ≥ 5 to ≤ 6) will be enrolled in Group 1.
- Group 2: Approximately 6 to 8 male or female subjects with moderate hepatic impairment (with a Child-Pugh score of ≥ 7 to ≤ 9) will be enrolled in Group 2.
- Group 3: Approximately 6 to 8 healthy male or female subjects with normal hepatic function will be enrolled in Group 3. Subjects in Group 3 will be matched to subjects in Group 2 with respect to sex, age (± 10 years), and weight (± 10% body mass index [BMI]). Group 3 will also serve as the control group for Group 1.
- Group 4: Approximately 6 to 8 male or female subjects with severe hepatic impairment (with a Child-Pugh score of ≥ 10 to ≤ 13) will be enrolled in Group 4.
- Group 5: Approximately 6 to 8 healthy male or female subjects with normal hepatic function will be enrolled in Group 5. Subjects in Group 5 will be matched to subjects in Group 4 with respect to sex, age (± 10 years), and weight (± 10% BMI).
This study employs a staged design as follows:
- Subjects with mild or moderate hepatic impairment and matching healthy subjects with normal hepatic function (Groups 1 through 3) will be enrolled concomitantly.
- At least 4 subjects with mild or moderate hepatic impairment must demonstrate satisfactory safety and tolerability for up to 4 days after dosing before subjects with severe hepatic impairment may be dosed.
- Two subjects with severe hepatic impairment must demonstrate satisfactory safety and tolerability for up to 4 days after dosing before the remaining subjects with severe hepatic impairment may be dosed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Administration of CC-90001 | Experimental | Drug: CC-90001Single oral dose of 200 mg of CC-90001 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subject must understand and voluntarily sign an Informed Consent Form (ICF) prior to any study-related assessments/procedures being conducted.
- Subject is willing and able to adhere to the study visit schedule and other protocol requirements, including the restrictions.
- Subject is male, or non-pregnant and non-nursing female between ≥ 18 and ≤ 70 years of age at the time of signing the ICF.
- Subject has Body mass index (BMI) ≥ 18 and ≤ 40 kg/m2 at screening.
- Female subjects NOT of childbearing potential must:
Key exclusion criteria (18 listed)
- Subject has any significant and relevant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study at the Investigator's discretion.
- Subject has any condition that places the subject at an unacceptable risk if he or she were to participate in the study.
- Subject has any condition that confounds the ability to interpret data from the study.
- Subject is pregnant or breastfeeding.
- Subject was exposed to an investigational drug (new chemical entity) within 30 days preceding the first dose administration, or 5 half-lives of that investigational drug, if known (whichever was longer).
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 |
|---|---|---|
| CC-90001CC-90001 | Drug | Administration of CC-90001 |
Primary outcome
Pharmacokinetic- AUC0-t
Time frame: UP to approximately 7 Days
Estimation of AUC calculated from time zero to the last measured time point
Pharmacokinetic- AUC0-∞
Time frame: UP to approximately 7 Days
Estimation of AUC calculated from time zero to infinity
Pharmacokinetic- Cmax
Time frame: UP to approximately Day 1
Estimation of observed maximum plasma concentration
Pharmacokinetic- Tmax
Time frame: UP to approximately Day 1
Estimation of time to Cmax
Pharmacokinetic- t1/2
Time frame: Up to approximately 7 days
Estimation of terminal elimination half-life
Pharmacokinetic- CL/F
Time frame: Up to approximately 7 days
Estimation of apparent clearance of drug from plasma after extravascular administration
Pharmacokinetic- Vz/F
Time frame: Up to approximately 7 days
Estimation of apparent volume of distribution during the terminal phase
1 secondary outcome
Adverse Events (AEs)
Time frame: From enrollment until at least 28 days after completion of study treatment
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 27 Jul 2020.
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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.
Kofi Mensah, MD, PhD study director
Celgene
4 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 CC-90001 in people with Hepatic Impairment, run by Celgene at 4 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 12 inclusion and 18 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 27 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Pharmacokinetic- AUC0-t (time frame: UP to approximately 7 Days). The study lists 7 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 27 Jul 2020.