Healthy VolunteersPhase 1NCT04839809
A Study to Assess Safety, Tolerability, and Pharmacokinetics of CC-92480 Formulations in Healthy Adult Participants
A Phase 1 study testing CC-92480 in people with Healthy Volunteers, run by Celgene at 1 site in United States.
Trial summary
This is a Phase 1 study that will be conducted in 2 parts. Participants may participate in 1 part only. Part 1 will be a randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, and PK of CC-92480-02 (Formulation A) administered orally under fasted conditions in… 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?
- CC-92480
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2021to 8 Oct 2021
- 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
- Participants must satisfy the following criteria to be enrolled in the study:
- Must understand and voluntarily sign a written informed consent form (ICF) prior to any study-related assessments/procedures being conducted.
- Healthy adult female of nonchildbearing potential or male of any race, between 18 to 55 years of age (inclusive) at the time of signing the ICF, and in good health as determined by the screening history and Physical examination (PE).
- Agrees to abide by the requirements and restrictions outlined in the CC-92480 Pregnancy Prevention Plan for Participants in Clinical Trials.
- For males:
- Practice true abstinence (which must be reviewed on a monthly basis, as applicable) or agree to use a barrier contraception not made of natural (animal) membrane (eg, latex or polyurethane condoms are acceptable) when engaging in sexual activity with a female of childbearing potential (FCBP) while on study medication, and for at 3 months after the last dose of study medication even if he has undergone a successful vasectomy.
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- For females:
- Female participants must have been surgically sterilized (hysterectomy or bilateral oophorectomy; proper documentation required) at least 6 months before screening or be postmenopausal (defined as 24 months without menses before screening, with a serum follicle-stimulation hormone (FSH) level of > 40 IU/L at screening.
- Must have a body mass index between 18 and 33 kg/m2 (inclusive) at the time of signing the ICF.
- Clinical laboratory test results must be within the respective reference ranges; or if not, the results be clinically insignificant according to the Investigator's medical judgment.
- Participant must agree and be willing to consume a standard high-fat meal (which may contain gluten), for Part 2 participants only.
Who cannot join
- The presence of any of the following will exclude a participant from enrollment:
- Female of childbearing potential, pregnant, or breastfeeding.
- History of any clinically significant and relevant neurological, gastrointestinal (GI), renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, or other major disorders as determined by the Investigator.
- History of severe (eg, anaphylactic, anaphylactoid, Stevens-Johnson, angioedematous) reaction to a drug, or adverse reactions to multiple drugs.
- Use of any prescribed systemic or topical medication (including but not limited to analgesics, anesthetics, etc) within 28 days of the first dose administration.
- Use of any nonprescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines) within 14 days of the first dose administration.
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- Donation of blood or plasma within 8 weeks before the first dose administration to a blood bank or blood donation center.
- History of drug abuse (as defined by the current version of the Diagnostic and Statistical Manual [DSM]) within 2 years before first dose administration, or positive drug screening test reflecting consumption of illicit drugs.
- History of alcohol abuse (as defined by the current version of the DSM) within 2 years before first dose administration, or positive alcohol screen.
- Known to have serum hepatitis or known to be a carrier of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV Ab), or have a reactive result to the test for human immunodeficiency virus (HIV) antibodies at screening.
- Use of tobacco- or nicotine-containing products within 3 months prior to Day -1, as assessed by medical history and physical examination, or positive urine cotinine test at screening.
- Vaccination within 30 days of first dose administration or plans to receive vaccination (live and attenuated) within 30 days after dosing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Two-Part Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of CC-92480; the Relative Bioavailability Among Two Formulations of CC 92480; and Food Effect on the Exposures of Two Formulations of CC 92480 in Healthy Adult Subjects
This is a Phase 1 study that will be conducted in 2 parts. Participants may participate in 1 part only.
- Part 1 will be a randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, and PK of CC-92480-02 (Formulation A) administered orally under fasted conditions in healthy adult participants.
- Part 2 will be a randomized, open-label, 2 × 4 crossover study (Periods 1, 2, 3, and 4) to evaluate the relative bioavailability (RBA) of Formulation A versus Formulation B under fasted conditions and explore safety, tolerability, and PK effects of food on Formulation A and Formulation B in healthy adult participants.
- Conditions
- Healthy Volunteers
- Being tested
- CC-92480, Placebo
- Keywords
- Healthy Volunteers, CC-92480, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-92480Drug
Oral
PlaceboOther
Oral
| Study group | Role | What they receive |
|---|---|---|
| CC-92480-02 (Formulation A) with Placebo | Experimental | CC-92480-02 (Formulation A) or matching placebo to be administered orally under fasted conditions. Receives: Drug: CC-92480; Other: Placebo |
| CC-92480 (Formulation B)- fasted condition | Experimental | A single oral dose of CC-92480 (Formulation B) administered under fasted conditions. Receives: Drug: CC-92480 |
| CC-92480-02 (Formulation A) - fasted condition | Experimental | A single oral dose of CC-92480-02 (Formulation A) administered under fasted conditions. Receives: Drug: CC-92480 |
| CC-92480 (Formulation B) - Low-fat meal | Experimental | A single oral dose of CC-92480 (Formulation B) administered under fed conditions (low-fat meal). Receives: Drug: CC-92480 |
| CC-92480-02 (Formulation A) - high-fat meal | Experimental | A single oral dose of CC-92480-02 (Formulation A) administered under fed conditions (high-fat meal). Receives: Drug: CC-92480 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics- Cmax Part 1
Maximum plasma concentration of drug
Measured: Up to 96 hours after dosing
Pharmacokinetics- Tmax Part 1
Time to maximum plasma concentration
Measured: Up to 96 hours after dosing
Pharmacokinetics- AUC0-∞Part 1
Area under the plasma concentration-time curve from time zero to infinity
Measured: Up to 96 hours after dosing
Pharmacokinetics- AUC0-t Part1
Area under the plasma concentration-time curve from time zero to the last observable concentration
Measured: Up to 96 hours after dosing
Pharmacokinetics- t½ Part 1
Terminal elimination half-life
Measured: Up to 96 hours after dosing
Pharmacokinetics- CL/F Part 1
Apparent total plasma clearance
Measured: Up to 96 hours after dosing
Pharmacokinetics- Vz/F Part 1
Apparent volume of distribution
Measured: Up to 96 hours after dosing
Pharmacokinetics- tlag Part 1
Lag time between time of administration and start of absorption
Measured: Up to 96 hours after dosing
Pharmacokinetics- Cmax Part 2
Maximum plasma concentration of drug
Measured: Up to 96 hours after dosing
Pharmacokinetics- Ratio of Cmax (Formulation A/Formulation B) Part 2
Ratio of maximum plasma concentration of drug
Measured: Up to 96 hours after dosing
Pharmacokinetics- AUC0-∞ Part 2
Area under the plasma concentration-time curve from time zero to infinity
Measured: Up to 96 hours after dosing
Pharmacokinetics- Ratio of AUC0-∞ (Formulation A/Formulation B) Part 2
Ratio of area under the plasma concentration-time curve from time zero to infinity
Measured: Up to 96 hours after dosing
Pharmacokinetics- AUC0-t Part 2
Area under the plasma concentration-time curve from time zero to the last observable concentration
Measured: Up to 96 hours after dosing
Pharmacokinetics- AUC0-t (Formulation A/Formulation B) Part 2
Area under the plasma concentration-time curve from time zero to the last observable concentration
Measured: Up to 96 hours after dosing
Pharmacokinetics- Tmax Part 2
Time to maximum plasma concentration
Measured: Up to 96 hours after dosing
Pharmacokinetics- t½ Part 2
Terminal elimination half-life
Measured: Up to 96 hours after dosing
Pharmacokinetics- CL/F Part 2
Apparent total plasma clearance
Measured: Up to 96 hours after dosing
Pharmacokinetics- Vz/F Part 2
Apparent volume of distribution
Measured: Up to 96 hours after dosing
Pharmacokinetics- tlag Part 2
Lag time between time of administration and start of absorption
Measured: Up to 96 hours after dosing
Secondary outcomes (24)
Pharmacokinetics- Cmax (high-fat meal)
Maximum plasma concentration of drug
Measured: Up to 96 hours after dosing
Pharmacokinetics- Ratio (Fed/Fasted) of Cmax (high-fat meal)
Ratio of maximum plasma concentration of drug
Measured: Up to 96 hours after dosing
Pharmacokinetics- AUC0-∞(high-fat meal)
Area under the plasma concentration-time curve from time zero to infinity
Measured: Up to 96 hours after dosing
Pharmacokinetics- Ratio (Fed/Fasted) of AUC0-∞ (high-fat meal)
Ratio of area under the plasma concentration-time curve from time zero to infinity
Measured: Up to 96 hours after dosing
Pharmacokinetics- AUC0-t (high-fat meal)
Area under the plasma concentration-time curve from time zero to the last observable concentration
Measured: Up to 96 hours after dosing
Pharmacokinetics- Ratio (Fed/Fasted) of AUC0-t (high-fat meal)
Ratio of area under the plasma concentration-time curve from time zero to the last observable concentration
Measured: Up to 96 hours after dosing
Pharmacokinetics- Tmax (high-fat meal)
Time to maximum plasma concentration
Measured: Up to 96 hours after dosing
Pharmacokinetics- AUC0-24 (high-fat meal)
Area under the plasma concentration-time curve from time zero to 24 hours post dose
Measured: Up to 96 hours after dosing
Pharmacokinetics- t½ (high-fat meal)
Terminal elimination half-life
Measured: Up to 96 hours after dosing
Pharmacokinetics- CL/F (high-fat meal)
Apparent total plasma clearance
Measured: Up to 96 hours after dosing
Pharmacokinetics- Vz/F (high-fat meal)
Apparent volume of distribution
Measured: Up to 96 hours after dosing
Pharmacokinetics- tlag (high-fat meal)
Lag time between time of administration and start of absorption
Measured: Up to 96 hours after dosing
Pharmacokinetics- Cmax (low-fat meal)
Maximum plasma concentration of drug
Measured: Up to 96 hours after dosing
Pharmacokinetics- Ratio (Fed/Fasted) of Cmax (low-fat meal)
Ratio of maximum plasma concentration of drug
Measured: Up to 96 hours after dosing
Pharmacokinetics- AUC0-∞(low-fat meal)
Area under the plasma concentration-time curve from time zero to infinity
Measured: Up to 96 hours after dosing
Pharmacokinetics- Ratio (Fed/Fasted) of AUC0-∞(low-fat meal)
Ratio of area under the plasma concentration-time curve from time zero to infinity
Measured: Up to 96 hours after dosing
Pharmacokinetics- AUC0-t (low-fat meal)
Area under the plasma concentration-time curve from time zero to the last observable concentration
Measured: Up to 96 hours after dosing
Pharmacokinetics- Ratio (Fed/Fasted) of AUC0-t (low-fat meal)
Ratio of area under the plasma concentration-time curve from time zero to the last observable concentration
Measured: Up to 96 hours after dosing
Pharmacokinetics- Tmax (low-fat meal)
Time to maximum plasma concentration
Measured: Up to 96 hours after dosing
Pharmacokinetics- t½ (low-fat meal)
Terminal elimination half-life
Measured: Up to 96 hours after dosing
Pharmacokinetics- CL/F (low-fat meal)
Apparent total plasma clearance
Measured: Up to 96 hours after dosing
Pharmacokinetics- Vz/F (low-fat meal)
Apparent volume of distribution
Measured: Up to 96 hours after dosing
Pharmacokinetics- tlag (low-fat meal)
Lag time between time of administration and start of absorption
Measured: Up to 96 hours after dosing
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 (ie, 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 study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start19 Jan 2021
- Primary completion8 Oct 2021
- Study completion8 Oct 2021
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 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
- NCT04839809
- Sponsor's protocol ID
- CC-92480-CP-003
- Status last verified
- Dec 2021
- First submitted
- 7 Apr 2021
- Last updated
- 10 Dec 2021
- 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 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Two-Part Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of CC-92480; the Relative Bioavailability Among Two Formulations of CC 92480; and Food Effect on the Exposures of Two Formulations of CC 92480 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04839809
- Acronym / sponsor ID
- CC-92480-CP-003
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Volunteers, CC-92480, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 19 Jan 2021 (actual)
- Primary completion
- 8 Oct 2021 (actual)
- Study completion
- 8 Oct 2021 (actual)
- First posted
- 9 Apr 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 a Phase 1 study that will be conducted in 2 parts. Participants may participate in 1 part only.
- Part 1 will be a randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, and PK of CC-92480-02 (Formulation A) administered orally under fasted conditions in healthy adult participants.
- Part 2 will be a randomized, open-label, 2 × 4 crossover study (Periods 1, 2, 3, and 4) to evaluate the relative bioavailability (RBA) of Formulation A versus Formulation B under fasted conditions and explore safety, tolerability, and PK effects of food on Formulation A and Formulation B in healthy adult participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| CC-92480-02 (Formulation A) with Placebo | Experimental | Drug: CC-92480, Other: PlaceboCC-92480-02 (Formulation A) or matching placebo to be administered orally under fasted conditions. |
| CC-92480 (Formulation B)- fasted condition | Experimental | Drug: CC-92480A single oral dose of CC-92480 (Formulation B) administered under fasted conditions. |
| CC-92480-02 (Formulation A) - fasted condition | Experimental | Drug: CC-92480A single oral dose of CC-92480-02 (Formulation A) administered under fasted conditions. |
| CC-92480 (Formulation B) - Low-fat meal | Experimental | Drug: CC-92480A single oral dose of CC-92480 (Formulation B) administered under fed conditions (low-fat meal). |
| CC-92480-02 (Formulation A) - high-fat meal | Experimental | Drug: CC-92480A single oral dose of CC-92480-02 (Formulation A) administered under fed conditions (high-fat meal). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Must understand and voluntarily sign a written informed consent form (ICF) prior to any study-related assessments/procedures being conducted.
- Healthy adult female of nonchildbearing potential or male of any race, between 18 to 55 years of age (inclusive) at the time of signing the ICF, and in good health as determined by the screening history and Physical examination (PE).
- Agrees to abide by the requirements and restrictions outlined in the CC-92480 Pregnancy Prevention Plan for Participants in Clinical Trials.
- For males:
- For females:
Key exclusion criteria (12 listed)
- Female of childbearing potential, pregnant, or breastfeeding.
- History of any clinically significant and relevant neurological, gastrointestinal (GI), renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, or other major disorders as determined by the Investigator.
- History of severe (eg, anaphylactic, anaphylactoid, Stevens-Johnson, angioedematous) reaction to a drug, or adverse reactions to multiple drugs.
- Use of any prescribed systemic or topical medication (including but not limited to analgesics, anesthetics, etc) within 28 days of the first dose administration.
- Use of any nonprescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines) within 14 days of the first dose administration.
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-92480Oral | Drug | CC-92480 (Formulation B) - Low-fat meal, CC-92480 (Formulation B)- fasted condition, CC-92480-02 (Formulation A) - fasted condition, CC-92480-02 (Formulation A) - high-fat meal, CC-92480-02 (Formulation A) with Placebo |
| PlaceboOral | Other | CC-92480-02 (Formulation A) with Placebo |
Primary outcome
Pharmacokinetics- Cmax Part 1
Time frame: Up to 96 hours after dosing
Maximum plasma concentration of drug
Pharmacokinetics- Tmax Part 1
Time frame: Up to 96 hours after dosing
Time to maximum plasma concentration
Pharmacokinetics- AUC0-∞Part 1
Time frame: Up to 96 hours after dosing
Area under the plasma concentration-time curve from time zero to infinity
Pharmacokinetics- AUC0-t Part1
Time frame: Up to 96 hours after dosing
Area under the plasma concentration-time curve from time zero to the last observable concentration
Pharmacokinetics- t½ Part 1
Time frame: Up to 96 hours after dosing
Terminal elimination half-life
Pharmacokinetics- CL/F Part 1
Time frame: Up to 96 hours after dosing
Apparent total plasma clearance
Pharmacokinetics- Vz/F Part 1
Time frame: Up to 96 hours after dosing
Apparent volume of distribution
Pharmacokinetics- tlag Part 1
Time frame: Up to 96 hours after dosing
Lag time between time of administration and start of absorption
Pharmacokinetics- Cmax Part 2
Time frame: Up to 96 hours after dosing
Maximum plasma concentration of drug
Pharmacokinetics- Ratio of Cmax (Formulation A/Formulation B) Part 2
Time frame: Up to 96 hours after dosing
Ratio of maximum plasma concentration of drug
Pharmacokinetics- AUC0-∞ Part 2
Time frame: Up to 96 hours after dosing
Area under the plasma concentration-time curve from time zero to infinity
Pharmacokinetics- Ratio of AUC0-∞ (Formulation A/Formulation B) Part 2
Time frame: Up to 96 hours after dosing
Ratio of area under the plasma concentration-time curve from time zero to infinity
Pharmacokinetics- AUC0-t Part 2
Time frame: Up to 96 hours after dosing
Area under the plasma concentration-time curve from time zero to the last observable concentration
Pharmacokinetics- AUC0-t (Formulation A/Formulation B) Part 2
Time frame: Up to 96 hours after dosing
Area under the plasma concentration-time curve from time zero to the last observable concentration
Pharmacokinetics- Tmax Part 2
Time frame: Up to 96 hours after dosing
Time to maximum plasma concentration
Pharmacokinetics- t½ Part 2
Time frame: Up to 96 hours after dosing
Terminal elimination half-life
Pharmacokinetics- CL/F Part 2
Time frame: Up to 96 hours after dosing
Apparent total plasma clearance
Pharmacokinetics- Vz/F Part 2
Time frame: Up to 96 hours after dosing
Apparent volume of distribution
Pharmacokinetics- tlag Part 2
Time frame: Up to 96 hours after dosing
Lag time between time of administration and start of absorption
24 secondary outcomes
Pharmacokinetics- Cmax (high-fat meal)
Time frame: Up to 96 hours after dosing
Pharmacokinetics- Ratio (Fed/Fasted) of Cmax (high-fat meal)
Time frame: Up to 96 hours after dosing
Pharmacokinetics- AUC0-∞(high-fat meal)
Time frame: Up to 96 hours after dosing
Pharmacokinetics- Ratio (Fed/Fasted) of AUC0-∞ (high-fat meal)
Time frame: Up to 96 hours after dosing
Pharmacokinetics- AUC0-t (high-fat meal)
Time frame: Up to 96 hours after dosing
Pharmacokinetics- Ratio (Fed/Fasted) of AUC0-t (high-fat meal)
Time frame: Up to 96 hours after dosing
Pharmacokinetics- Tmax (high-fat meal)
Time frame: Up to 96 hours after dosing
Pharmacokinetics- AUC0-24 (high-fat meal)
Time frame: Up to 96 hours after dosing
Pharmacokinetics- t½ (high-fat meal)
Time frame: Up to 96 hours after dosing
Pharmacokinetics- CL/F (high-fat meal)
Time frame: Up to 96 hours after dosing
Pharmacokinetics- Vz/F (high-fat meal)
Time frame: Up to 96 hours after dosing
Pharmacokinetics- tlag (high-fat meal)
Time frame: Up to 96 hours after dosing
Pharmacokinetics- Cmax (low-fat meal)
Time frame: Up to 96 hours after dosing
Pharmacokinetics- Ratio (Fed/Fasted) of Cmax (low-fat meal)
Time frame: Up to 96 hours after dosing
Pharmacokinetics- AUC0-∞(low-fat meal)
Time frame: Up to 96 hours after dosing
Pharmacokinetics- Ratio (Fed/Fasted) of AUC0-∞(low-fat meal)
Time frame: Up to 96 hours after dosing
Pharmacokinetics- AUC0-t (low-fat meal)
Time frame: Up to 96 hours after dosing
Pharmacokinetics- Ratio (Fed/Fasted) of AUC0-t (low-fat meal)
Time frame: Up to 96 hours after dosing
Pharmacokinetics- Tmax (low-fat meal)
Time frame: Up to 96 hours after dosing
Pharmacokinetics- t½ (low-fat meal)
Time frame: Up to 96 hours after dosing
Pharmacokinetics- CL/F (low-fat meal)
Time frame: Up to 96 hours after dosing
Pharmacokinetics- Vz/F (low-fat meal)
Time frame: Up to 96 hours after dosing
Pharmacokinetics- tlag (low-fat meal)
Time frame: Up to 96 hours after dosing
Incidence of 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 10 Dec 2021.
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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
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 CC-92480 in people with Healthy Volunteers, run by Celgene 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 11 inclusion and 12 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 10 Dec 2021. 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?
Pharmacokinetics- Cmax Part 1 (time frame: Up to 96 hours after dosing). The study lists 19 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 10 Dec 2021.