Renal InsufficiencyPhase 1NCT03097016
A Study to Assess the Pharmacokinetics of CC-122 in Subjects With Mild, Moderate, and Severe Renal Impairment
A Phase 1 study testing CC-122 in people with Renal Insufficiency, run by Celgene at 2 sites in United States.
Trial summary
Multi-center, open-label, single-dose study to assess the PK of a single oral dose of 3 mg CC-122 in subjects with mild, moderate, and severe renal impairment as compared to sex, age (± 15 years), and weight (± 20%) matched control subjects with normal renal function. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Insufficiency
- What is being tested?
- CC-122
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Mar 2017to 23 Dec 2017
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 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 ≥ 18 and ≤ 80 years of age at the time of signing the informed consent.
- Subject has a body mass index between 18 and 40 kg/m2 (inclusive).
- Subject is afebrile
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- Subject has a normal or clinically acceptable 12-lead Electrocardiogram at screening. In addition:
- If male, subject has a QTcF value ≤ 470 msec at screening.
- If female, subject has a QTcF value ≤ 480 msec at screening.
- Subject agrees to comply and abide by the requirements and restrictions outlined in the CC-122 Pregnancy Prevention Plan for Subjects in Clinical Trials.
- Female subjects must have been surgically sterilized (hysterectomy, bilateral oophorectomy, proper documentation required) at least 6 months before screening, or be postmenopausal (defined as 24 consecutive months without menses before screening, with a follicle-stimulating hormone level of> 40 IU/L at screening).
- Male subject must practice true abstinence* (which must be reviewed on a monthly basis, as applicable) or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions (if applicable) and for at least 90 days following study drug discontinuation, even if he has undergone a successful vasectomy.
- True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Period abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- Inclusion Criteria for Subjects with Mild, Moderate, or Severe Renal Impairment.
- Each subject with mild, moderate, or severe renal impairment must also meet ALL of the criteria listed below for entry:
- Subject has mild, moderate, or severe (not requiring dialysis) renal impairment as defined by Estimated glomerular filtration rate (eGFR) at screening.
- Subject has supine systolic BP: 90 to 180 mmHg, supine diastolic BP: 60 to 110 mmHg, and pulse rate: 40 to 110 bpm.
- Must be medically stable for at least 1 month before study drug administration with clinically acceptable medical history, Physical exam (PE), clinical laboratory tests, vital signs, and 12-lead ECGs consistent with the underlying stable mild moderate or severe renal impairment condition, as judged by the Investigator.
- Must be stable in concomitant medication regimen (defined as not starting a new medication[s] or a change in the dosage or frequency of the concomitant medication[s] within 7 days or 5 half-lives [whichever is longer] before dosing with study drug).
- Each matched healthy subject must meet ALL the criteria listed below for entry:
- Subject has supine systolic BP: 90 to 160 mmHg, supine diastolic BP: 50 to 100 mmHg, and pulse rate: 40 to 100 bpm
- Must be free of any clinically significant disease that would interfere with the study evaluations.
- Must have normal renal function, as defined by an eGFR ≥ 90 mL/min/1.73 m2 (calculated using the Modification of Diet in Renal Disease (MDRD) equation).
- Must match subjects in Group 1, 3, and 5 with respect to sex, age (± 15 years), and weight (± 20%).
- Must be in good health as determined by past medical history, PE, vital signs, ECG, and clinical laboratory safety tests. Clinical laboratory safety tests (i.e., hematology, chemistry, and urinalysis) and 12-lead ECGs must be within normal limits or clinically acceptable as judged by the Investigator.
Who cannot join
- 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 Informed Consent Form.
- 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 surgical or medical condition(s) possibly affecting drug absorption, distribution, metabolism, excretion, eg, bariatric procedure. Subjects with cholecystectomy and appendectomy may be included.
- Subject is a female of childbearing potential, pregnant, or breastfeeding.
- Subject donated blood or plasma within 8 weeks before dose administration to a blood bank or blood donation center.
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- Subject has a history of alcohol abuse (as defined by the current version of the Diagnostic and Statistical Manual [DSM]) within 6 months before the first dose administration, or positive alcohol screen.
- Subject has a history of drug abuse (as defined by the current version of the DSM) 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 serum hepatitis or known to be a carrier of the hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCV Ab) or have a positive result to the test for Human immunodeficiency virus (HIV) antibodies at screening. If a positive result for HCV AB is reported, the Investigator may assess the suitability of the subject based upon normal liver function test results and either no history of Hepatitis C, or documented sustained viral response (ie, undetectable HCV viral load during and 12 weeks after completion of accepted HCV treatment). If the subject meets both criteria, and the Investigator determines this as acceptable, the subject can be considered for enrollment into the trial.
- Subject was exposed to an investigational drug (new chemical entity) within 30 days before dosing, or 5 half-lives of that investigational drug, if known (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 used approved medications or herbal medicines that are moderate or strong cytochrome P450 (CYP)1A2 or 3A4/5 inducers and/or inhibitors (including St. John's wort) within 14 days or 5 half-lives of dosing, whichever is longer. The Indiana University "Cytochrome P450 Drug Interaction Table" should be utilized to determine inhibitors and/or inducers of CYP1A2 and CYP3A4/5. (http://medicine.iupui.edu/clinpharm/ddis/table.aspx).
- Subject has received 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.
- Exclusion Criteria for Subjects with Mild, Moderate, or Severe Renal Impairment.
- Each renal impairment subject will be excluded from entry if ANY of the criteria listed below are met:
- Any serious and or unstable medical condition occurring within 3 months prior to signing the Informed Consent Form (excluding stable renal impairment and associated comorbidities).
- Any clinically significant laboratory abnormality not related to renal impairment and related complications.
- History of renal transplant.
- Subjects with renal impairment should be excluded from study if laboratory values are outside the following ranges and, in the opinion of the Investigator, are considered to prevent the subject from safely completing the study:
- Exclusion Criteria for Subjects with Mild, Moderate, or Severe Renal Impairment.
- Each matched healthy subject will be excluded from entry if ANY of the criteria listed below are met:
- 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 used any prescribed systemic or topical medication within 30 days prior to signing of the Informed Consent Form.
- Subject used any non-prescribed systemic or topical medication within 7 days prior to signing of the Informed Consent Form (with the exception of vitamin/mineral supplements).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
DaVita Clinical Research
Lakewood, Colorado, 80228
DaVita Clinical Research
Minneapolis, Minnesota, 55404
About this study
Official title: A Phase 1, Open-label, Single-dose Study to Assess the Pharmacokinetics (PK) of CC-122 in Subjects With Mild, Moderate and Severe Renal Impairment
Multi-center, open-label, single-dose study to assess the PK of a single oral dose of 3 mg CC-122 in subjects with mild, moderate, and severe renal impairment as compared to sex, age (± 15 years), and weight (± 20%) matched control subjects with normal renal function.
Read the detailed description
This will be a multi-center, open-label, single-dose study to assess the PK of a single oral dose of 3 mg CC-122 in subjects with mild, moderate, and severe renal impairment as compared to sex, age (± 15 years), and weight (± 20%) matched control subjects with normal renal function. Estimated renal function for the purpose of group assignment will be determined at screening. Matched control subjects will have normal renal function, defined using the Cockcroft-Gault (C G) equation, as an estimated creatinine clearance (CLcr) of ≥ 90 mL/min. Subjects with impaired renal function will be classified by stage of renal impairment (mild, moderate, or severe) using estimated glomerular filtration rate (eGFR), calculated by the Modification of Diet in Renal Disease (MDRD) equation. Each group will enroll at least 2 subjects of each sex
During the course of the study, each subject will participate in a Screening period (Days - 21 to -2), Treatment Period (including baseline visit), and a follow-up telephone call between Days 11 to 18. Subjects will be screened for eligibility. Eligible subjects will return to the clinical site on Day 1 for baseline assessments, and will be domiciled at the clinical site from Day 1 to Day 4. PK samples will be collected through 72 hours post dose. Safety will be monitored throughout study.
The study will be conducted in compliance with the International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.
- Conditions
- Renal Insufficiency
- Being tested
- CC-122
- Keywords
- Renal Impairment, Pharmacokinetics, CC-122, Mild, Moderate, Severe
- Medical subject headings
- Renal Insufficiency, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-122Drug
All subjects will receive one 3 mg CC-122 capsule the morning of Day 1 which will be administered in the fasted state.
| Study group | Role | What they receive |
|---|---|---|
| Single oral dose of 3 mg CC-122 | Experimental | All subjects will receive one 3 mg CC-122 capsule the morning of Day 1 which will be administered in the fasted state. Receives: Drug: CC-122 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics - Tmax
Time to Observed maximum serum concentration (Cmax)
Measured: up to 72 hours
Pharmacokinetics - Cmax
Observed maximum serum concentration (Cmax)
Measured: up to 72 hours
Pharmacokinetics - AUC0-t
Area under the serum concentration-time curve calculated from time zero to the last measured time point
Measured: up to 72 hours
Pharmacokinetics - AUC0-∞
Area under the serum concentration-time curve calculated from time zero to infinity
Measured: up to 72 hours
Pharmacokinetics - t1/2
Terminal elimination half-life
Measured: Up to 72 hours
Pharmacokinetics - CL/F
Apparent clearance of drug from serum when dosed orally
Measured: Up to 72 hours
Pharmacokinetics - Vz/F
Apparent volume of distribution when dosed subcutaneously during the terminal phase
Measured: Up to 72 hours
Pharmacokinetics - CLR
Renal Clearance
Measured: Up to 72 hours
Pharmacokinetics - Ae
Amount of excretion
Measured: Up to 72 hours
Secondary outcomes (1)
Adverse Events (AEs)
Number of participants with adverse events
Measured: Up to 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start30 Mar 2017
- Primary completion23 Dec 2017
- Study completion23 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal InsufficiencyStudies 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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leon Carayannopoulos, MD, Study director, Celgene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03097016
- Sponsor's protocol ID
- CC-122-CP-005
- Status last verified
- Apr 2018
- First submitted
- 24 Mar 2017
- Last updated
- 26 Apr 2018
- 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 26 Apr 2018. 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 (PK) of CC-122 in Subjects With Mild, Moderate and Severe Renal Impairment
- ClinicalTrials.gov ID
- NCT03097016
- Acronym / sponsor ID
- CC-122-CP-005
- Conditions
- Renal Insufficiency
- Keywords
- Renal Impairment, Pharmacokinetics, CC-122, Mild, Moderate, Severe
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2017 (actual)
- Primary completion
- 23 Dec 2017 (actual)
- Study completion
- 23 Dec 2017 (actual)
- First posted
- 31 Mar 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.
Multi-center, open-label, single-dose study to assess the PK of a single oral dose of 3 mg CC-122 in subjects with mild, moderate, and severe renal impairment as compared to sex, age (± 15 years), and weight (± 20%) matched control subjects with normal renal function.
Detailed description
This will be a multi-center, open-label, single-dose study to assess the PK of a single oral dose of 3 mg CC-122 in subjects with mild, moderate, and severe renal impairment as compared to sex, age (± 15 years), and weight (± 20%) matched control subjects with normal renal function. Estimated renal function for the purpose of group assignment will be determined at screening. Matched control subjects will have normal renal function, defined using the Cockcroft-Gault (C G) equation, as an estimated creatinine clearance (CLcr) of ≥ 90 mL/min. Subjects with impaired renal function will be classified by stage of renal impairment (mild, moderate, or severe) using estimated glomerular filtration rate (eGFR), calculated by the Modification of Diet in Renal Disease (MDRD) equation. Each group will enroll at least 2 subjects of each sex
During the course of the study, each subject will participate in a Screening period (Days - 21 to -2), Treatment Period (including baseline visit), and a follow-up telephone call between Days 11 to 18. Subjects will be screened for eligibility. Eligible subjects will return to the clinical site on Day 1 for baseline assessments, and will be domiciled at the clinical site from Day 1 to Day 4. PK samples will be collected through 72 hours post dose. Safety will be monitored throughout study.
The study will be conducted in compliance with the International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single oral dose of 3 mg CC-122 | Experimental | Drug: CC-122All subjects will receive one 3 mg CC-122 capsule the morning of Day 1 which will be administered in the fasted state. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- 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 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 ≥ 18 and ≤ 80 years of age at the time of signing the informed consent.
- Subject has a body mass index between 18 and 40 kg/m2 (inclusive).
Key exclusion criteria (27 listed)
- 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 Informed Consent Form.
- 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 surgical or medical condition(s) possibly affecting drug absorption, distribution, metabolism, excretion, eg, bariatric procedure. Subjects with cholecystectomy and appendectomy may be included.
- Subject is a female of childbearing potential, pregnant, or breastfeeding.
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-122All subjects will receive one 3 mg CC-122 capsule the morning of Day 1 which will be administered in the fasted state. | Drug | Single oral dose of 3 mg CC-122 |
Primary outcome
Pharmacokinetics - Tmax
Time frame: up to 72 hours
Time to Observed maximum serum concentration (Cmax)
Pharmacokinetics - Cmax
Time frame: up to 72 hours
Observed maximum serum concentration (Cmax)
Pharmacokinetics - AUC0-t
Time frame: up to 72 hours
Area under the serum concentration-time curve calculated from time zero to the last measured time point
Pharmacokinetics - AUC0-∞
Time frame: up to 72 hours
Area under the serum concentration-time curve calculated from time zero to infinity
Pharmacokinetics - t1/2
Time frame: Up to 72 hours
Terminal elimination half-life
Pharmacokinetics - CL/F
Time frame: Up to 72 hours
Apparent clearance of drug from serum when dosed orally
Pharmacokinetics - Vz/F
Time frame: Up to 72 hours
Apparent volume of distribution when dosed subcutaneously during the terminal phase
Pharmacokinetics - CLR
Time frame: Up to 72 hours
Renal Clearance
Pharmacokinetics - Ae
Time frame: Up to 72 hours
Amount of excretion
1 secondary outcome
Adverse Events (AEs)
Time frame: Up to 40 days
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 26 Apr 2018.
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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.
Leon Carayannopoulos, MD study director
Celgene
2 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-122 in people with Renal Insufficiency, run by Celgene at 2 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 25 inclusion and 27 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 26 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 - Tmax (time frame: up to 72 hours). The study lists 9 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 26 Apr 2018.