Healthy VolunteersPhase 1NCT05899738
A Study to Compare the Relative Bioavailability of Two Iberdomide (CC-220) Formulations and to Assess The Effect Of Food on the Drug Levels of Iberdomide in Healthy Adult Participants
A Phase 1 study testing Iberdomide in people with Healthy Volunteers, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the relative bioavailability for the new iberdomide powder for reconstitution formulation relative to the reference capsule formulation and to assess the effect of food on the pharmacokinetics of powder for reconstitution formulation in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Iberdomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2023to 6 Jul 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index of 18.0 to 33.0 kilograms (kg)/square meter, inclusive, and body weight ≥50 kg.
- A female participant is eligible to participate if she is not of childbearing potential as defined in the protocol.
- Males who are sexually active with woman of childbearing potential must agree to follow instructions for method(s) of contraception as described in the protocol and included in the informed consent form.
- Male participants are required to use a condom and must refrain from donating sperm during the intervention period and for at least 28 days after the last dose of study intervention.
Who cannot join
- Any significant acute or chronic medical illness.
- Current or recent (within 3 months of the first dose of the investigational medicinal product) gastrointestinal disease or procedure that could possibly affect drug absorption, distribution, metabolism, and excretion (for example, bariatric procedure).
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiogram, or clinical laboratory determinations.
- Female who are of childbearing potential and females who are breastfeeding.
- Note: Other protocol-defined inclusion/exclusion criteria apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Local Institution - 0001
Daytona Beach, Florida, 32117
About this study
Official title: A Phase 1, Open-Label, Randomized, Two-Part, Two-Period, Two-Sequence Crossover Study to Assess the Relative Bioavailability of Iberdomide (CC-220) Powder for Reconstitution Formulation to the Reference Capsule Formulation and to Assess the Effect of Food on the Pharmacokinetics of Powder for Reconstitution Formulation in Healthy Adult Participants
The purpose of this study is to evaluate the relative bioavailability for the new iberdomide powder for reconstitution formulation relative to the reference capsule formulation and to assess the effect of food on the pharmacokinetics of powder for reconstitution formulation in healthy adult participants.
- Conditions
- Healthy Volunteers
- Being tested
- Iberdomide
- Keywords
- Healthy, Iberdomide, Bioavailability, Crossover, Powder Formulation, Food Effect, Fed, Fasted
- Medical subject headings
- Lecithin Cholesterol Acyltransferase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IberdomideDrug
Also called BMS-986382, CC-220
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Iberdomide Powder (Fasted), followed by Iberdomide Capsule (Fasted) | Experimental | Not described Receives: Drug: Iberdomide |
| Iberdomide Capsule (Fasted), followed by Iberdomide Powder (Fasted) | Experimental | Not described Receives: Drug: Iberdomide |
| Iberdomide Powder (Fasted), followed by Iberdomide Powder (Fed) | Experimental | Not described Receives: Drug: Iberdomide |
| Iberdomide Powder (Fed), followed by Iberdomide Powder (Fasted) | Experimental | Not described Receives: Drug: Iberdomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax)
Measured: Up to 72 hours post-dose for Period 1 and Period 2 (each period is 4 days, with a 5-9 day washout between each dose)
Area Under the Plasma Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC(0-T))
Measured: Up to 72 hours post-dose for Period 1 and Period 2 (each period is 4 days, with a 5-9 day washout between each dose)
Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF))
Measured: Up to 72 hours post-dose for Period 1 and Period 2 (each period is 4 days, with a 5-9 day washout between each dose)
Secondary outcomes (5)
Number of Participants with Adverse Events
Measured: Up to 28 days
Number of Participants with Vital Sign Abnormalities
Measured: Up to 20 days
Number of Participants with Clinical Laboratory Abnormalities
Measured: Up to 20 days
Number of Participants with Electrocardiogram Abnormalities
Measured: Up to 20 days
Number of Participants with Physical Examination Abnormalities
Measured: Up to 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start18 May 2023
- Primary completion6 Jul 2023
- Study completion6 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celgene
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899738
- Sponsor's protocol ID
- IM048-1038
- Status last verified
- Jul 2024
- First submitted
- 17 May 2023
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Randomized, Two-Part, Two-Period, Two-Sequence Crossover Study to Assess the Relative Bioavailability of Iberdomide (CC-220) Powder for Reconstitution Formulation to the Reference Capsule Formulation and to Assess the Effect of Food on the Pharmacokinetics of Powder for Reconstitution Formulation in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT05899738
- Acronym / sponsor ID
- IM048-1038
- Conditions
- Healthy Volunteers
- Keywords
- Healthy, Iberdomide, Bioavailability, Crossover, Powder Formulation, Food Effect, Fed, Fasted
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Celgene
- Study start
- 18 May 2023 (actual)
- Primary completion
- 6 Jul 2023 (actual)
- Study completion
- 6 Jul 2023 (actual)
- First posted
- 12 Jun 2023 (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.
The purpose of this study is to evaluate the relative bioavailability for the new iberdomide powder for reconstitution formulation relative to the reference capsule formulation and to assess the effect of food on the pharmacokinetics of powder for reconstitution formulation in healthy adult participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Iberdomide Powder (Fasted), followed by Iberdomide Capsule (Fasted) | Experimental | Drug: Iberdomide |
| Iberdomide Capsule (Fasted), followed by Iberdomide Powder (Fasted) | Experimental | Drug: Iberdomide |
| Iberdomide Powder (Fasted), followed by Iberdomide Powder (Fed) | Experimental | Drug: Iberdomide |
| Iberdomide Powder (Fed), followed by Iberdomide Powder (Fasted) | Experimental | Drug: Iberdomide |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Body mass index of 18.0 to 33.0 kilograms (kg)/square meter, inclusive, and body weight ≥50 kg.
- A female participant is eligible to participate if she is not of childbearing potential as defined in the protocol.
- Males who are sexually active with woman of childbearing potential must agree to follow instructions for method(s) of contraception as described in the protocol and included in the informed consent form.
- Male participants are required to use a condom and must refrain from donating sperm during the intervention period and for at least 28 days after the last dose of study intervention.
Key exclusion criteria (5 listed)
- Any significant acute or chronic medical illness.
- Current or recent (within 3 months of the first dose of the investigational medicinal product) gastrointestinal disease or procedure that could possibly affect drug absorption, distribution, metabolism, and excretion (for example, bariatric procedure).
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiogram, or clinical laboratory determinations.
- Female who are of childbearing potential and females who are breastfeeding.
- Note: Other protocol-defined inclusion/exclusion criteria apply.
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: BMS-986382, CC-220Specified dose on specified days | Drug | Iberdomide Capsule (Fasted), followed by Iberdomide Powder (Fasted), Iberdomide Powder (Fasted), followed by Iberdomide Capsule (Fasted), Iberdomide Powder (Fasted), followed by Iberdomide Powder (Fed), Iberdomide Powder (Fed), followed by Iberdomide Powder (Fasted) |
Primary outcome
Maximum Observed Plasma Concentration (Cmax)
Time frame: Up to 72 hours post-dose for Period 1 and Period 2 (each period is 4 days, with a 5-9 day washout between each dose)
Area Under the Plasma Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC(0-T))
Time frame: Up to 72 hours post-dose for Period 1 and Period 2 (each period is 4 days, with a 5-9 day washout between each dose)
Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF))
Time frame: Up to 72 hours post-dose for Period 1 and Period 2 (each period is 4 days, with a 5-9 day washout between each dose)
5 secondary outcomes
Number of Participants with Adverse Events
Time frame: Up to 28 days
Number of Participants with Vital Sign Abnormalities
Time frame: Up to 20 days
Number of Participants with Clinical Laboratory Abnormalities
Time frame: Up to 20 days
Number of Participants with Electrocardiogram Abnormalities
Time frame: Up to 20 days
Number of Participants with Physical Examination Abnormalities
Time frame: Up to 20 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 Jul 2024.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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
1 site 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 Healthy Volunteers, run by Bristol-Myers Squibb at 1 site 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 4 inclusion and 5 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 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 1 site 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?
Maximum Observed Plasma Concentration (Cmax) (time frame: Up to 72 hours post-dose for Period 1 and Period 2 (each period is 4 days, with a 5-9 day washout between each dose)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2024.