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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04211545
Recruitment Status : Recruiting
First Posted : December 26, 2019
Last Update Posted : December 26, 2019
Sponsor:
Information provided by (Responsible Party):
Celgene

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: Rabeprazole Drug: CC-92480 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : October 21, 2019
Estimated Primary Completion Date : December 23, 2019
Estimated Study Completion Date : December 23, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Administration of CC-92480 and Rabeprazole
Test Formulation CC-92480 and Reference Formulation will be administered orally at 1.6 mg. Rabeprazole will be administered orally at 40 mg.
Drug: Rabeprazole
Rabeprazole

Drug: CC-92480
CC-92480




Primary Outcome Measures :
  1. Pharmacokinetics - AUC0-∞ (Reference Formulation) [ Time Frame: Up to 5 days ]
    Area under the plasma concentration-time curve from time zero to infinity

  2. Pharmacokinetics - AUC0-∞ (Test Formulation) [ Time Frame: Up to 5 days ]
    Area under the plasma concentration-time curve from time zero to the last observable concentration at time t


Secondary Outcome Measures :
  1. Pharmacokinetics -Cmax (Reference Formulation) [ Time Frame: Day 1 ]
    Maximum plasma concentration

  2. Pharmacokinetics - Cmax (Test Formulation) [ Time Frame: Day 1 ]
    Maximum plasma concentration

  3. Pharmacokinetics - AUC0-t (Reference Formulation) [ Time Frame: Up to 5 days ]
    Area under the plasma concentration-time curve from time zero to the last observable concentration at time t

  4. Pharmacokinetics - AUC0-t (Test Formulation) [ Time Frame: Up to 5 days ]
    Area under the plasma concentration-time curve from time zero to the last observable concentration at time t

  5. Pharmacokinetics -Tmax (Reference Formulation) [ Time Frame: Day 1 ]
    Time to peak (maximum) plasma concentration

  6. Pharmacokinetics -Tmax (Test Formulation) [ Time Frame: Day 1 ]
    Time to peak (maximum)plasma concentration

  7. Pharmacokinetics - CL/F (Reference Formulation) [ Time Frame: Up to 5 days ]
    Apparent total plasma clearance

  8. Pharmacokinetics - CL/F (Test Formulation) [ Time Frame: Up to 5 days ]
    Apparent total plasma clearance

  9. Pharmacokinetics - Vz/F (Reference Formulation) [ Time Frame: Up to 5 days ]
    Apparent volume of distribution

  10. Pharmacokinetics - Vz/F (Test Formulation) [ Time Frame: Up to 5 days ]
    Apparent volume of distribution

  11. Pharmacokinetics - t1/2 (Reference Formulation) [ Time Frame: Up to 5 days ]
    Terminal elimination half-life

  12. Pharmacokinetics - t1/2 (Test Formulation) [ Time Frame: Up to 5 days ]
    Terminal elimination half-life

  13. Adverse Events (AEs) [ Time Frame: From enrollment until at least 28 days after completion of study treatment ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study (partial):

  1. Must understand and voluntarily sign a written informed consent form (ICF) prior to any study-related assessments/procedures being performed.
  2. 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.
  3. 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.
  4. For males:

    1. 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.
    2. 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.
  5. Must have a body mass index between 18 and 33 kg/m2 (inclusive) at the time of signing the ICF.
  6. 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.

Exclusion Criteria:

The presence of any of the following will exclude a subject from enrollment:

  1. 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.
  2. 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).
  3. Use of tobacco - or nicotine-containing products within 3 months prior to Day -1 (Period 1 for Part 2).
  4. Vaccination within 30 days of first dose administration or plans to receive vaccination within 30 days after dosing.
  5. Subjects with active hepatitis and HIV
  6. Use of any nonprescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines) within 14 days of the first dose administration.
  7. Use of CYP3A inducers and inhibitors (including St. John's Wort) within 30 days of the first dose administration.
  8. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04211545


Contacts
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Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations
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United States, Texas
PPD Phase 1 Clinic Recruiting
Austin, Texas, United States, 78744
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Leon Carayannopoulos, MD Celgene

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT04211545    
Other Study ID Numbers: CC-92480-CP-002
U1111-1242-7394 ( Other Identifier: WHO )
First Posted: December 26, 2019    Key Record Dates
Last Update Posted: December 26, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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/

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: See Plan Description
Access Criteria: See Plan Description
URL: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Celgene:
Healthy Subjects
CC-92480
Pharmacokinetics
Additional relevant MeSH terms:
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Rabeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action