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Healthy VolunteerPhase 1NCT04211545

Relative Bioavailability and PPI Effects of CC-92480 Test and Reference Formulations in Healthy Subjects

A Phase 1 study testing Rabeprazole and CC-92480 in people with Healthy Volunteer, run by Celgene at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase 1, open-label, randomized, four-period, crossover study in healthy females of nonchildbearing potential and male subjects - to be conducted at a single center in the United States. The study will consist of a screening phase, a baseline phase, four treatment periods, and a follow-up phone call. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteer
What is being tested?
Rabeprazole and CC-92480
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
21 Oct 2019to 26 Dec 2019
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

  • Subjects must satisfy the following criteria to be enrolled in the study (partial):
  • Must understand and voluntarily sign a written informed consent form (ICF) prior to any study-related assessments/procedures being performed.
  • Must be able to communicate with the Investigator, understand and comply with the requirements of the study, and agree to adhere to restrictions and examination schedules.
  • Healthy adult male or female 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 PE.
  • For males:
  • Practice true abstinence (which must be reviewed on a monthly basis) 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 and for at least 3 months following investigational product discontinuation, even if he has undergone a successful vasectomy.
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  • Agree to use 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) 1 while on study medication, and for at 3 months after the last dose of study medication.
  • 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 judgement.

Who cannot join

  • The presence of any of the following will exclude a subject from enrollment:
  • History of any clinically significant and relevant neurological, GI, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, or other major disorders as determined by the Investigator.
  • Exposure to an investigational drug (new chemical entity) within 30 days preceding the first dose administration, or 5 half-lives of that investigational drug, if known (whichever is longer).
  • Use of tobacco - or nicotine-containing products within 3 months prior to Day -1 (Period 1 for Part 2).
  • Vaccination within 30 days of first dose administration or plans to receive vaccination within 30 days after dosing.
  • Subjects with active hepatitis and HIV
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  • Use of any nonprescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines) within 14 days of the first dose administration.
  • Use of CYP3A inducers and inhibitors (including St. John's Wort) within 30 days of the first dose administration.
  • Any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism and excretion (ADME), eg, bariatric procedure. Appendectomy and cholecystectomy are acceptable. Prior procedures of unclear ADME significance should be reviewed with the Sponsor's Medical Monitor.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • PPD Phase 1 Clinic

    Austin, Texas, 78744

Other trials in United States

About this study

Official title: A Phase 1, Open-label Study to Assess the Single Dose Pharmacokinetics and Relative Bioavailability of a Test Capsule Formulation of CC-92480 Compared to a Reference CC 92480 Capsule Formulation and the Effect of a Proton Pump Inhibitor on the Pharmacokinetics of CC 92480 From Test and Reference Formulations in Healthy Subjects

This is a Phase 1, open-label, randomized, four-period, crossover study in healthy females of nonchildbearing potential and male subjects - to be conducted at a single center in the United States.

The study will consist of a screening phase, a baseline phase, four treatment periods, and a follow-up phone call. The 4 treatment periods are divided into two pairs (Period 1 and 2 and Period 3 and 4), potentially separated by an intermission during which subjects will be discharged from the research unit: Periods 1 and 2 support relative bioavailability (RBA) estimation, while Periods 3 and 4 support estimation of PPI effects.

Being tested
Rabeprazole, CC-92480
Keywords
Healthy Subjects, CC-92480, Pharmacokinetics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RabeprazoleDrug

    Rabeprazole

  • CC-92480Drug

    CC-92480

Study groups in NCT04211545
Study groupRoleWhat they receive
Administration of CC-92480 and RabeprazoleExperimentalTest Formulation CC-92480 and Reference Formulation will be administered orally at 1.6 mg. Rabeprazole will be administered orally at 40 mg.
Receives: Drug: Rabeprazole; Drug: CC-92480

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetics - AUC0-∞ (Reference Formulation)

    Area under the plasma concentration-time curve from time zero to infinity

    Measured: Up to 5 days

  2. Pharmacokinetics - AUC0-∞ (Test Formulation)

    Area under the plasma concentration-time curve from time zero to the last observable concentration at time t

    Measured: Up to 5 days

Secondary outcomes (13)

  1. Pharmacokinetics -Cmax (Reference Formulation)

    Maximum plasma concentration

    Measured: Day 1

  2. Pharmacokinetics - Cmax (Test Formulation)

    Maximum plasma concentration

    Measured: Day 1

  3. Pharmacokinetics - AUC0-t (Reference Formulation)

    Area under the plasma concentration-time curve from time zero to the last observable concentration at time t

    Measured: Up to 5 days

  4. Pharmacokinetics - AUC0-t (Test Formulation)

    Area under the plasma concentration-time curve from time zero to the last observable concentration at time t

    Measured: Up to 5 days

  5. Pharmacokinetics -Tmax (Reference Formulation)

    Time to peak (maximum) plasma concentration

    Measured: Day 1

  6. Pharmacokinetics -Tmax (Test Formulation)

    Time to peak (maximum)plasma concentration

    Measured: Day 1

  7. Pharmacokinetics - CL/F (Reference Formulation)

    Apparent total plasma clearance

    Measured: Up to 5 days

  8. Pharmacokinetics - CL/F (Test Formulation)

    Apparent total plasma clearance

    Measured: Up to 5 days

  9. Pharmacokinetics - Vz/F (Reference Formulation)

    Apparent volume of distribution

    Measured: Up to 5 days

  10. Pharmacokinetics - Vz/F (Test Formulation)

    Apparent volume of distribution

    Measured: Up to 5 days

  11. Pharmacokinetics - t1/2 (Reference Formulation)

    Terminal elimination half-life

    Measured: Up to 5 days

  12. Pharmacokinetics - t1/2 (Test Formulation)

    Terminal elimination half-life

    Measured: Up to 5 days

  13. Adverse Events (AEs)

    An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject 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 subject's health, including laboratory test values (as specified by the criteria in Section 10.3), 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.

  1. First posted26 Dec 2019
  2. Study start21 Oct 2019
  3. Primary completion26 Dec 2019
  4. Study completion26 Dec 2019

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04211545
Sponsor's protocol ID
CC-92480-CP-002
Other IDs
U1111-1242-7394
Status last verified
May 2020
First submitted
24 Dec 2019
Last updated
8 May 2020
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

  • Burnett J, Sychterz C, Katz J, Shakeel F, Silva J, Chen W, Shahane A, Wang X, Lamba M, Gaudy A. Application of Physiologically Based Pharmacokinetic Modeling to Inform Dose Selection of Mezigdomide in a Phase I Drug-Drug Interaction Study. Clin Pharmacol Ther. 2026 Mar;119(3):641-650. doi: 10.1002/cpt.70082. Epub 2025 Oct 7.

    PubMed 41058119

  • Wu F, Liu L, Gaudy A, Wang X, Carayannopoulos L, Pourdehnad M, Lamba M. Model based assessment of food and acid reducing agent effects on oral absorption of mezigdomide (CC-92480), a novel cereblon E3 ligase modulator. CPT Pharmacometrics Syst Pharmacol. 2023 Oct;12(10):1473-1484. doi: 10.1002/psp4.13024. Epub 2023 Sep 13.

    PubMed 37705327

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Rabeprazole and CC-92480 in people with Healthy Volunteer, 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 9 inclusion and 9 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 8 May 2020. 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 - AUC0-∞ (Reference Formulation) (time frame: Up to 5 days). The study lists 2 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 NCT04211545, which also lists 2 linked publications.

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 8 May 2020.

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