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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

Tracking Information
First Submitted Date  ICMJE December 24, 2019
First Posted Date  ICMJE December 26, 2019
Last Update Posted Date December 26, 2019
Actual Study Start Date  ICMJE October 21, 2019
Estimated Primary Completion Date December 23, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 24, 2019)
  • Pharmacokinetics - AUC0-∞ (Reference Formulation) [ Time Frame: Up to 5 days ]
    Area under the plasma concentration-time curve from time zero to infinity
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 24, 2019)
  • Pharmacokinetics -Cmax (Reference Formulation) [ Time Frame: Day 1 ]
    Maximum plasma concentration
  • Pharmacokinetics - Cmax (Test Formulation) [ Time Frame: Day 1 ]
    Maximum plasma concentration
  • 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
  • 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
  • Pharmacokinetics -Tmax (Reference Formulation) [ Time Frame: Day 1 ]
    Time to peak (maximum) plasma concentration
  • Pharmacokinetics -Tmax (Test Formulation) [ Time Frame: Day 1 ]
    Time to peak (maximum)plasma concentration
  • Pharmacokinetics - CL/F (Reference Formulation) [ Time Frame: Up to 5 days ]
    Apparent total plasma clearance
  • Pharmacokinetics - CL/F (Test Formulation) [ Time Frame: Up to 5 days ]
    Apparent total plasma clearance
  • Pharmacokinetics - Vz/F (Reference Formulation) [ Time Frame: Up to 5 days ]
    Apparent volume of distribution
  • Pharmacokinetics - Vz/F (Test Formulation) [ Time Frame: Up to 5 days ]
    Apparent volume of distribution
  • Pharmacokinetics - t1/2 (Reference Formulation) [ Time Frame: Up to 5 days ]
    Terminal elimination half-life
  • Pharmacokinetics - t1/2 (Test Formulation) [ Time Frame: Up to 5 days ]
    Terminal elimination half-life
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Relative Bioavailability and PPI Effects of CC-92480 Test and Reference Formulations in Healthy Subjects
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Healthy Volunteer
Intervention  ICMJE
  • Drug: Rabeprazole
    Rabeprazole
  • Drug: CC-92480
    CC-92480
Study Arms  ICMJE 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.
Interventions:
  • Drug: Rabeprazole
  • Drug: CC-92480
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 24, 2019)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 23, 2019
Estimated Primary Completion Date December 23, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04211545
Other Study ID Numbers  ICMJE CC-92480-CP-002
U1111-1242-7394 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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/
Responsible Party Celgene
Study Sponsor  ICMJE Celgene
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Leon Carayannopoulos, MD Celgene
PRS Account Celgene
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP