Healthy VolunteersPhase 1NCT06363630
A Study to Evaluate the Effect of Cytochrome P450 (CYP) 3A Inhibitor (Itraconazole) and Inducer (Rifampin) on the Drug Levels of Golcadomide (BMS-986369) in Healthy Participants
A Phase 1 study testing Itraconazole, Rifampin and Golcadomide in people with Healthy Volunteers, run by Celgene at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the drug-drug interaction (DDI) potential of coadministration of itraconazole or rifampin on the single dose drug levels of golcadomide. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Itraconazole, Rifampin and Golcadomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Apr 2024to 29 Aug 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female non smoking participants, of any race, as determined by the investigator to have no clinically significant deviation from normal, in medical history and physical examination which correspond to a condition that could potentially increase the risk for the participants, or jeopardize the integrity of the study data, in 12-lead ECG measurements, vital signs, and clinical laboratory determinations, at screening and at check-in.
- Body mass index (BMI) 18.0 to 33.0 kg/m2, inclusive. BMI = weight (kg)/(height [m])2 for participants.
- Participant is afebrile (febrile is defined as ≥ 38°C or ≥ 100.4°F), with systolic blood pressure ≥ 90 and ≤ 140 mmHg, diastolic blood pressure ≥ 50 and ≤ 90 mmHg, and pulse rate ≥ 40 and ≤ 90 beats per minute at screening, confirmed by repeat, as per clinical site's standard.
- Must have a normal or clinically acceptable 12-lead ECG at screening: Participants must have a corrected QT interval using QTcF value ≤ 450 msec.
- Absolute neutrophil counts must be greater than 2,500/μL at screening and Day -1.
- Must have adequate laboratory test results for renal and hepatic function as assessed by the PI (Principal Investigator). Laboratory testing may be repeated to find all possible well-qualified participants.
Who cannot join
- Any significant acute or chronic medical illness that presents a potential risk to the participant in the opinion of the investigator and/or may compromise the objectives of the study.
- History of clinically significant endocrine, gastrointestinal (GI), cardiovascular (CV), peripheral vascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary (GU) abnormalities/diseases.
- Has any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism and excretion (ADME). Appendectomy and cholecystectomy are acceptable. Prior procedures of unclear ADME significance should be reviewed with the Sponsor's Medical Monitor.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Local Institution - 0002
Atlanta, Georgia, 30331
Local Institution - 0001
Lenexa, Kansas, 66219
About this study
Official title: A Phase 1, Open-label, 2-part, 2-period, Fixed-sequence, Crossover Study to Evaluate the Effect of Cytochrome P450 (CYP) 3A Inhibitor (Itraconazole) and Inducer (Rifampin) on the Pharmacokinetics of Golcadomide (BMS-986369) in Healthy Participants
The purpose of this study is to evaluate the drug-drug interaction (DDI) potential of coadministration of itraconazole or rifampin on the single dose drug levels of golcadomide.
- Conditions
- Healthy Volunteers
- Being tested
- Itraconazole, Rifampin, Golcadomide
- Keywords
- pharmacokinetics, BMS-986369, CC-99282, healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ItraconazoleDrug
Specified dose on specified days.
RifampinDrug
Specified dose on specified days
GolcadomideDrug
Also called BMS-986369
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | Not described Receives: Drug: Itraconazole; Drug: Golcadomide |
| Part 2 | Experimental | Not described Receives: Drug: Rifampin; Drug: Golcadomide |
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 Day 67
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))
Measured: Up to Day 67
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Measured: Up to Day 67
Secondary outcomes (11)
Number of participants with adverse events (AEs)
Measured: Up to Day 69
Number of participants with physical exam abnormalities
Measured: Up to Day 69
Number of participants with vital sign abnormalities
Measured: Up to Day 69
Number of participants with clinical laboratory safety test abnormalities
Measured: Up to Day 69
Number of participants with electrocardiogram abnormalities
Measured: Up to Day 69
Number of participants with concomitant medications
Measured: Up to Day 69
Number of participants with concomitant procedures
Measured: Up to Day 69
Time of maximum observed plasma concentration (Tmax)
Measured: Up to Day 67
Apparent terminal phase half-life (T-HALF)
Measured: Up to Day 67
Apparent total body clearance (CLT/F)
Measured: Up to Day 67
Apparent volume of distribution (Vz/F)
Measured: Up to Day 67
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start23 Apr 2024
- Primary completion29 Aug 2024
- Study completion29 Aug 2024
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 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 35 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
- NCT06363630
- Sponsor's protocol ID
- CA073-1000
- Status last verified
- Sep 2024
- First submitted
- 9 Apr 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, 2-part, 2-period, Fixed-sequence, Crossover Study to Evaluate the Effect of Cytochrome P450 (CYP) 3A Inhibitor (Itraconazole) and Inducer (Rifampin) on the Pharmacokinetics of Golcadomide (BMS-986369) in Healthy Participants
- ClinicalTrials.gov ID
- NCT06363630
- Acronym / sponsor ID
- CA073-1000
- Conditions
- Healthy Volunteers
- Keywords
- pharmacokinetics, BMS-986369, CC-99282, healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 23 Apr 2024 (actual)
- Primary completion
- 29 Aug 2024 (actual)
- Study completion
- 29 Aug 2024 (actual)
- First posted
- 12 Apr 2024 (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 drug-drug interaction (DDI) potential of coadministration of itraconazole or rifampin on the single dose drug levels of golcadomide.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: Itraconazole, Drug: Golcadomide |
| Part 2 | Experimental | Drug: Rifampin, Drug: Golcadomide |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy male and female non smoking participants, of any race, as determined by the investigator to have no clinically significant deviation from normal, in medical history and physical examination which correspond to a condition that could potentially increase the risk for the participants, or jeopardize the integrity of the study data, in 12-lead ECG measurements, vital signs, and clinical laboratory determinations, at screening and at check-in.
- Body mass index (BMI) 18.0 to 33.0 kg/m2, inclusive. BMI = weight (kg)/(height [m])2 for participants.
- Participant is afebrile (febrile is defined as ≥ 38°C or ≥ 100.4°F), with systolic blood pressure ≥ 90 and ≤ 140 mmHg, diastolic blood pressure ≥ 50 and ≤ 90 mmHg, and pulse rate ≥ 40 and ≤ 90 beats per minute at screening, confirmed by repeat, as per clinical site's standard.
- Must have a normal or clinically acceptable 12-lead ECG at screening: Participants must have a corrected QT interval using QTcF value ≤ 450 msec.
- Absolute neutrophil counts must be greater than 2,500/μL at screening and Day -1.
Key exclusion criteria (4 listed)
- Any significant acute or chronic medical illness that presents a potential risk to the participant in the opinion of the investigator and/or may compromise the objectives of the study.
- History of clinically significant endocrine, gastrointestinal (GI), cardiovascular (CV), peripheral vascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary (GU) abnormalities/diseases.
- Has any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism and excretion (ADME). Appendectomy and cholecystectomy are acceptable. Prior procedures of unclear ADME significance should be reviewed with the Sponsor's Medical Monitor.
- 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 |
|---|---|---|
| ItraconazoleSpecified dose on specified days. | Drug | Part 1 |
| RifampinSpecified dose on specified days | Drug | Part 2 |
| GolcadomideAlso: BMS-986369Specified dose on specified days | Drug | Part 1, Part 2 |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Up to Day 67
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))
Time frame: Up to Day 67
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Time frame: Up to Day 67
11 secondary outcomes
Number of participants with adverse events (AEs)
Time frame: Up to Day 69
Number of participants with physical exam abnormalities
Time frame: Up to Day 69
Number of participants with vital sign abnormalities
Time frame: Up to Day 69
Number of participants with clinical laboratory safety test abnormalities
Time frame: Up to Day 69
Number of participants with electrocardiogram abnormalities
Time frame: Up to Day 69
Number of participants with concomitant medications
Time frame: Up to Day 69
Number of participants with concomitant procedures
Time frame: Up to Day 69
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to Day 67
Apparent terminal phase half-life (T-HALF)
Time frame: Up to Day 67
Apparent total body clearance (CLT/F)
Time frame: Up to Day 67
Apparent volume of distribution (Vz/F)
Time frame: Up to Day 67
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 Sep 2024.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
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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
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 Itraconazole, Rifampin and Golcadomide in people with Healthy Volunteers, 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 6 inclusion and 4 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 Sep 2024. 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?
Maximum observed plasma concentration (Cmax) (time frame: Up to Day 67). 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 27 Sep 2024; AzTrials last refreshed its copy on 7 Nov 2026.