Renal InsufficiencyPhase 1NCT04933747
Study to Evaluate Safety and Tolerability of Iberdomide (CC-220) in Participants With Kidney Impairment Compared to Participants With Normal Kidney Function
A Phase 1 study testing Iberdomide in people with Renal Insufficiency, run by Celgene at 3 sites in United States.
Trial summary
This is an open-label study of iberdomide in participants with severe renal impairment or participants receiving dialysis compared to participants with normal renal function. An open-label design was selected based on the objective nature of the primary endpoints (i.e., Pharmacokinetics parameter estimates based on… Read more about this study
- Who is it for?
- Ages 18 to 82 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Insufficiency
- What is being tested?
- Iberdomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 3 sitesUnited States
- Study dates
- 12 Aug 2021to 23 Jan 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 18 to 82 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must satisfy the following criteria to be enrolled in the study:
- Participant is ≥ 18 and ≤ 82 years of age at the time of signing the informed consent form (ICF).
- Participant must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
- Participant is able to communicate with the Investigator, understand and comply with the requirements of the study, and agree to adhere to restrictions, the study visit schedule, and other protocol requirements, including contraception requirements.
- Participant has a body mass index (BMI) ≥ 18 and ≤ 40 kg/m2 at screening.
- Participant has a body weight > 50 kg at screening.
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- Participant is afebrile (febrile is defined as ≥ 38°C or 100.4°F).
- Inclusion Criteria for Participants with Severe Renal Impairment (RI) - Group 1
- Participants in Group 1 must also satisfy the following criteria to be enrolled in the study:
- Participant has a supine systolic blood pressure (BP) ≥ 90 and ≤ 180 mm Hg, supine diastolic BP ≥ 60 and ≤ 110 mm Hg, and pulse rate ≥ 40 and ≤ 110 beats per minute.
- Participant has severe renal impairment as defined by an eGFR < 30 mL/min/1.73 m2 (and not requiring dialysis) at screening. The eGFR will be calculated using the Modification of Diet in Renal Disease (MDRD) equation.
- Participant must be medically stable for at least 1 month before the first IP administration with a clinically acceptable medical history, physical examination (PE), clinical laboratory safety test results, vital sign measurements, and 12-lead electrocardiograms (ECGs) consistent with the underlying stable RI condition, as judged by the Investigator.
- Participant must have a QTcF value < 480 ms.
- Participant 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 the first IP administration).
- Inclusion Criteria for Participants with Kidney Failure on IHD - Group 2
- Participants in Group 2 must also satisfy the following criteria to be enrolled in the study:
- Participant has a pulse rate ≥ 40 and ≤ 110 beats per minute. Blood pressure measurements must be consistent with the participant's underlying medical condition(s) and judged by the Investigator as being clinically acceptable for purposes of study entry.
- Participant must be medically stable for at least 1 month before the first IP administration with a clinically acceptable medical history, PE, clinical laboratory safety test results, vital sign measurements, and 12-lead ECGs consistent with the underlying kidney failure, as judged by the Investigator.
- Participant must be stable in concomitant medication regimen
- Participant has been attending an average of 3 hemodialysis treatments per week within the 3 months prior to screening.
- Inclusion Criteria for Participants with Normal Renal Function -Group 3
- Participant has a supine systolic BP ≥ 90 and ≤ 160 mm Hg, supine diastolic BP ≥ 50 and ≤ 100 mm Hg, and pulse rate ≥ 40 and ≤ 100 beats per minute.
- Participant is in good health, as determined by past medical history, PE, vital signs, 12-lead ECG, and clinical laboratory safety test results, and has normal renal function, as defined by having a Clcr > 90 mL/min estimated using the C-G equation, at screening.
- If male, participant has a QTcF value < 470 ms;
- If female, participant has a QTcF value < 480 ms.
- Participant must match at least 1 participant in Groups 1 or 2 with respect to sex, age (approximately ± 10 years), and BMI (approximately ± 30%).
Who cannot join
- The presence of any of the following will exclude a participant from enrollment:
- Participant has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study (excluding stable renal impairment and associated comorbidities for participants in Groups 1 and 2).
- Participant has any condition, including active or uncontrolled infection and/or the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study.
- Participant has any condition that confounds the ability to interpret data from the study.
- Participant has any surgical or medical condition(s) possibly affecting drug absorption, distribution, metabolism, or excretion
- Participant has any medical or dietary conditions affecting assessment of eGFR or creatinine clearance (not applicable for participants in Group 2).
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- Participant is a female of childbearing potential, pregnant, or breastfeeding.
- Participant has donated blood or plasma within 8 weeks prior to the first IP administration.
- Participant has a history of alcohol abuse within 6 months prior to the first IP administration, or positive alcohol screen.
- Participant has history of drug abuse within 6 months prior to the first IP administration, or positive drug screen that is not consistent with the participant's prescribed medication and/or medical history.
- Participant is known to have serum hepatitis; known to be a carrier of the hepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti-HBc); - have a positive result to the test for hepatitis B or hepatitis C virus (positive viral ribonucleic acid (RNA) titer for hepatitis C) at screening or have a positive result to the test for human immunodeficiency virus (HIV) antibodies at screening. Positive anti-HBc results may be further qualified with a hepatitis B virus (HBV) DNA test; subjects with non-detectable HBV levels may be included at the discretion of the Investigator.
- Participant has been exposed to an investigational drug (new chemical entity) within 30 days prior to the first IP administration, or 5 half-lives of that investigational drug, if known (whichever is longer).
- Participant has consumed any medication known to be a strong CYP3A inducer (including St. John's wort) within 30 days prior to the first IP administration.
- Participant has consumed any medication known to be a strong CYP3A inhibitor within 7 days prior to the first IP administration.
- Participant has consumed grapefruit, grapefruit juice, or any other grapefruit-containing product or oranges, orange juice, or any other product containing and/or made from oranges within 7 days prior to the first IP administration.
- Participant smokes more than 10 cigarettes per day, or the equivalent in other tobacco products (self-reported).
- Participant is part of the clinical site staff personnel or a family member of the clinical site staff.
- Participant has received immunization with a live or live attenuated vaccine within 30 days prior the first IP administration or is planning to receive immunization with a live or live attenuated vaccine within 30 days following administration of the last dose of IP.
- Participant has a history of multiple drug allergies or drug-related anaphylaxis.
- Exclusion Criteria for Participants with Severe Renal Impairment and Participants with Kidney Failure on IHD - Groups 1 and 2
- The presence of any of the following will also exclude a participant from enrollment:
- Participant has any serious and/or unstable medical condition occurring within 3 months prior to screening (excluding stable renal impairment and associated comorbidities) with complete resolution of any symptoms and no sequelae that would place the participant at a higher risk from receiving IP, based on Investigator assessment in consultation with the Medical Monitor.
- Participant has any clinically significant laboratory abnormality not related to renal impairment and related complications.
- Participant has a history of renal transplant.
- Participants who had a renal transplant approximately > 2 years which is no longer functioning are allowable.
- Exclusion Criteria for Participants with Normal Renal Function - Group 3
- The presence of any of the following will also exclude a participant from enrollment:
- Participant has used any prescribed systemic or topical medication within 30 days prior to the first dose administration.
- Participant has used any non-prescribed systemic or topical medication within 14 days prior to the first dose administration.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Local Institution - 002
Knoxville, Tennessee, 37920
Local Institution - 001
Orlando, Florida, 32809
Local Institution - 003
San Antonio, Texas, 78215
About this study
Official title: A Phase 1, Open-label, Multicenter Study to Evaluate the Pharmacokinetics of Iberdomide (CC-220) in Subjects With Renal Impairment Compared to Subjects With Normal Renal Function
This is an open-label study of iberdomide in participants with severe renal impairment or participants receiving dialysis compared to participants with normal renal function. An open-label design was selected based on the objective nature of the primary endpoints (i.e., Pharmacokinetics parameter estimates based on measurement of iberdomide and M12 concentrations). Participants with severe renal impairment (RI), participants with kidney failure on intermittent hemodialysis (IHD), and participants with normal renal function are being included in the current study. Participants with severe RI and kidney failure participants will be matched to participants with normal renal function based on sex, age (approximately ± 10 years), and body mass index (BMI; approximately ± 30%).
- Conditions
- Renal Insufficiency
- Being tested
- Iberdomide
- Keywords
- Renal Insufficiency, CC-220, Iberdomide, Phase 1
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IberdomideDrug
Also called CC-220
Administration of a single oral dose of 1mg iberdomide in participants
IberdomideDrug
Also called CC-220
Administration of a single oral dose of 1mg iberdomide in participants on 2 occasions - once on a dialysis day and once on a non-dialysis day
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Participants with severe Renal Impairment (RI) | Experimental | Severe Renal Impairment (RI), as defined by an eGFR < 30 mL/min/1.73 m2 and not requiring dialysis, at screening Receives: Drug: Iberdomide |
| Group 2: Participants with kidney failure who are on intermittent hemodialysis (IHD) | Experimental | Kidney failure participants on intermittent hemodialysis (IHD) Receives: Drug: Iberdomide |
| Group 3: Participants with normal renal function | Experimental | Normal renal function, as defined by a creatinine clearance (Clcr) > 90 mL/min estimated using the Cockcroft-Gault (C-G) equation, at screening. Receives: Drug: Iberdomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iberdomide Pharmacokinetics - AUC(0-T)
Estimation of area under the plasma concentration -time curve (AUC) calculated from time zero to time t, where t is the time point of the last measurable concentration
Measured: Up to 72 hours following the last dose of iberdomide
Metabolite M12 Pharmacokinetics - AUC(0-T)
Estimation of AUC calculated from time zero to time t, where t is the time point of the last measurable concentration
Measured: Up to 72 hours following the last dose of iberdomide
Iberdomide Pharmacokinetics - AUC(INF)
Estimation of AUC calculated from time zero extrapolated to infinity
Measured: Up to 72 hours following the last dose of iberdomide
Metabolite M12 Pharmacokinetics - AUC(INF)
Estimation of AUC calculated from time zero extrapolated to infinity
Measured: Up to 72 hours following the last dose of iberdomide
Iberdomide Pharmacokinetics - Cmax
Estimation of maximum observed plasma concentration
Measured: Up to 72 hours following the last dose of iberdomide
Iberdomide Pharmacokinetics - Tmax
Estimated time to Cmax
Measured: Up to 72 hours following the last dose of iberdomide
Metabolite M12 Pharmacokinetics - Tmax
Estimated time to Cmax
Measured: Up to 72 hours following the last dose of iberdomide
Iberdomide Pharmacokinetics - T-HALF
Estimation of terminal elimination half-life in plasma
Measured: Up to 72 hours following the last dose of iberdomide
Metabolite M12 Pharmacokinetics - T-HALF
Estimation of terminal elimination half-life in plasma
Measured: Up to 72 hours following the last dose of iberdomide
Iberdomide Pharmacokinetics - CLT/F
Apparent total plasma clearance when dosed orally
Measured: Up to 72 hours following the last dose of iberdomide
Iberdomide Pharmacokinetics - CLNR/F
Apparent nonrenal clearance
Measured: Up to 72 hours following the last dose of iberdomide
Iberdomide Pharmacokinetics - VZ/F
Estimation of apparent volume of distribution when dosed orally
Measured: Up to 72 hours following the last dose of iberdomide
Iberdomide Pharmacokinetics - CLR
Renal Clearance
Measured: Up to 72 hours following the last dose of iberdomide
Metabolite M12 Pharmacokinetics - CLR
Renal clearance
Measured: Up to 72 hours following the last dose of iberdomide
Iberdomide Pharmacokinetics - UR
Estimation of amount excreted in urine
Measured: Up to 72 hours following the last dose of iberdomide
Iberdomide Pharmacokinetics - CLD
Dialysis clearance
Measured: 4 hours post-start of dialysis
Secondary outcomes (1)
Incidence of Adverse Events (AEs)
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant 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 participant's health, including laboratory test values), regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE
Measured: From enrollment until at least 28 days after completion of the study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start12 Aug 2021
- Primary completion23 Jan 2023
- Study completion23 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04933747
- Sponsor's protocol ID
- CC-220-CP-008
- Status last verified
- Feb 2023
- First submitted
- 14 Jun 2021
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
Publications
Chen P, Lin H, Xue Y, Thomas M, Wang A, Li Y, Cheng Y. A population pharmacokinetic analysis to evaluate the impact of renal impairment on the pharmacokinetics of iberdomide. J Pharm Sci. 2025 Feb;114(2):1315-1325. doi: 10.1016/j.xphs.2025.01.015. Epub 2025 Jan 25.
PubMed 39870177
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Multicenter Study to Evaluate the Pharmacokinetics of Iberdomide (CC-220) in Subjects With Renal Impairment Compared to Subjects With Normal Renal Function
- ClinicalTrials.gov ID
- NCT04933747
- Acronym / sponsor ID
- CC-220-CP-008
- Conditions
- Renal Insufficiency
- Keywords
- Renal Insufficiency, CC-220, Iberdomide, Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2021 (actual)
- Primary completion
- 23 Jan 2023 (actual)
- Study completion
- 23 Jan 2023 (actual)
- First posted
- 22 Jun 2021 (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 an open-label study of iberdomide in participants with severe renal impairment or participants receiving dialysis compared to participants with normal renal function. An open-label design was selected based on the objective nature of the primary endpoints (i.e., Pharmacokinetics parameter estimates based on measurement of iberdomide and M12 concentrations). Participants with severe renal impairment (RI), participants with kidney failure on intermittent hemodialysis (IHD), and participants with normal renal function are being included in the current study. Participants with severe RI and kidney failure participants will be matched to participants with normal renal function based on sex, age (approximately ± 10 years), and body mass index (BMI; approximately ± 30%).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Participants with severe Renal Impairment (RI) | Experimental | Drug: IberdomideSevere Renal Impairment (RI), as defined by an eGFR < 30 mL/min/1.73 m2 and not requiring dialysis, at screening |
| Group 2: Participants with kidney failure who are on intermittent hemodialysis (IHD) | Experimental | Drug: IberdomideKidney failure participants on intermittent hemodialysis (IHD) |
| Group 3: Participants with normal renal function | Experimental | Drug: IberdomideNormal renal function, as defined by a creatinine clearance (Clcr) > 90 mL/min estimated using the Cockcroft-Gault (C-G) equation, at screening. |
Who may qualify
- Ages
- 18 to 82 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Participant is ≥ 18 and ≤ 82 years of age at the time of signing the informed consent form (ICF).
- Participant must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
- Participant is able to communicate with the Investigator, understand and comply with the requirements of the study, and agree to adhere to restrictions, the study visit schedule, and other protocol requirements, including contraception requirements.
- Participant has a body mass index (BMI) ≥ 18 and ≤ 40 kg/m2 at screening.
- Participant has a body weight > 50 kg at screening.
Key exclusion criteria (29 listed)
- Participant has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study (excluding stable renal impairment and associated comorbidities for participants in Groups 1 and 2).
- Participant has any condition, including active or uncontrolled infection and/or the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study.
- Participant has any condition that confounds the ability to interpret data from the study.
- Participant has any surgical or medical condition(s) possibly affecting drug absorption, distribution, metabolism, or excretion
- Participant has any medical or dietary conditions affecting assessment of eGFR or creatinine clearance (not applicable for participants in Group 2).
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 |
|---|---|---|
| IberdomideAlso: CC-220Administration of a single oral dose of 1mg iberdomide in participants | Drug | Group 1: Participants with severe Renal Impairment (RI), Group 3: Participants with normal renal function |
| IberdomideAlso: CC-220Administration of a single oral dose of 1mg iberdomide in participants on 2 occasions - once on a dialysis day and once on a non-dialysis day | Drug | Group 2: Participants with kidney failure who are on intermittent hemodialysis (IHD) |
Primary outcome
Iberdomide Pharmacokinetics - AUC(0-T)
Time frame: Up to 72 hours following the last dose of iberdomide
Estimation of area under the plasma concentration -time curve (AUC) calculated from time zero to time t, where t is the time point of the last measurable concentration
Metabolite M12 Pharmacokinetics - AUC(0-T)
Time frame: Up to 72 hours following the last dose of iberdomide
Estimation of AUC calculated from time zero to time t, where t is the time point of the last measurable concentration
Iberdomide Pharmacokinetics - AUC(INF)
Time frame: Up to 72 hours following the last dose of iberdomide
Estimation of AUC calculated from time zero extrapolated to infinity
Metabolite M12 Pharmacokinetics - AUC(INF)
Time frame: Up to 72 hours following the last dose of iberdomide
Estimation of AUC calculated from time zero extrapolated to infinity
Iberdomide Pharmacokinetics - Cmax
Time frame: Up to 72 hours following the last dose of iberdomide
Estimation of maximum observed plasma concentration
Iberdomide Pharmacokinetics - Tmax
Time frame: Up to 72 hours following the last dose of iberdomide
Estimated time to Cmax
Metabolite M12 Pharmacokinetics - Tmax
Time frame: Up to 72 hours following the last dose of iberdomide
Estimated time to Cmax
Iberdomide Pharmacokinetics - T-HALF
Time frame: Up to 72 hours following the last dose of iberdomide
Estimation of terminal elimination half-life in plasma
Metabolite M12 Pharmacokinetics - T-HALF
Time frame: Up to 72 hours following the last dose of iberdomide
Estimation of terminal elimination half-life in plasma
Iberdomide Pharmacokinetics - CLT/F
Time frame: Up to 72 hours following the last dose of iberdomide
Apparent total plasma clearance when dosed orally
Iberdomide Pharmacokinetics - CLNR/F
Time frame: Up to 72 hours following the last dose of iberdomide
Apparent nonrenal clearance
Iberdomide Pharmacokinetics - VZ/F
Time frame: Up to 72 hours following the last dose of iberdomide
Estimation of apparent volume of distribution when dosed orally
Iberdomide Pharmacokinetics - CLR
Time frame: Up to 72 hours following the last dose of iberdomide
Renal Clearance
Metabolite M12 Pharmacokinetics - CLR
Time frame: Up to 72 hours following the last dose of iberdomide
Renal clearance
Iberdomide Pharmacokinetics - UR
Time frame: Up to 72 hours following the last dose of iberdomide
Estimation of amount excreted in urine
Iberdomide Pharmacokinetics - CLD
Time frame: 4 hours post-start of dialysis
Dialysis clearance
1 secondary outcome
Incidence of Adverse Events (AEs)
Time frame: From enrollment until at least 28 days after completion of the 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 15 Feb 2023.
- Derived from this study: PubMed 39870177Chen P, Lin H, Xue Y, Thomas M, Wang A, Li Y, Cheng Y. A population pharmacokinetic analysis to evaluate the impact of renal impairment on the pharmacokinetics of iberdomide. J Pharm Sci. 2025 Feb;114(2):1315-1325. doi: 10.1016/j.xphs.2025.01.015. Epub 2025 Jan 25.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
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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 Iberdomide in people with Renal Insufficiency, 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 26 inclusion and 29 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 Feb 2023. 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?
Iberdomide Pharmacokinetics - AUC(0-T) (time frame: Up to 72 hours following the last dose of iberdomide). The study lists 16 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 NCT04933747, which also lists 1 linked publication.
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 Feb 2023.