Relative Bioavailability Study of CC-292

August 11, 2020 updated by: Celgene

An Open-label, Phase 1, Randomized, Seven-treatment, Seven-period, Crossover Study to Assess the Relative Bioavailability, pH Effect, Food Effect and Dose Proportionality of CC-292 Spray Dried Dispersion Formulation in Healthy Volunteers

To evaluate the PK profile of the newly developed CC-292 SDD formulation compared to CC-292 P22 tablet.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a single center, open-label, randomized, seven-treatment, seven-period, crossover design. The study will consist of a screening phase, a treatment phase, and a follow-up phone call. Approximately 24 healthy adult subjects (male or female) will be enrolled.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Indiana
      • Evansville, Indiana, United States, 47710
        • Covance Clinical Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Must understand and voluntarily sign a written Informed Consent Form (ICF) prior to any study-related assessments/procedures being conducted.
  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. Must be a male or female subject from any race between 18 to 65 years of age (inclusive) at the time of signing the ICF, and in good health as determined by Physical Examinations (PE).
  4. Must comply with the following acceptable forms of contraception:

    1. Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception with male condoms NOT made out of natural animal membrane (e.g., latex or polyurethane condoms are acceptable) while on study drug, and for at least 90 days after the last dose of study drug.
    2. Females of childbearing potential (FCBP) 1 must have a negative pregnancy test at Screening and at Baseline (i.e., on Day -1). FCBP who engage in activity in which conception is possible must agree to use one of the following forms of contraception during their entire participation in the study and for at least 30 days after administration of the last dose of study drug:

      • Option 1: Any one of the following: non-oral hormonal contraception (e.g., injection, implant, transdermal patch, vaginal ring); intrauterine device; tubal ligation; or a partner with a vasectomy; OR
      • Option 2: Oral contraceptive pills PLUS one additional barrier method of the following: (a) male or female condom NOT made out of natural animal membrane (e.g., latex or polyurethane is acceptable); (b) diaphragm with spermicide; (c) cervical cap with spermicide; or (d) contraceptive sponge with spermicide; OR
      • Option 3: TWO of the following barrier methods: (a) male or female condom NOT made out of natural animal membrane (e.g., latex or polyurethane is acceptable); (b) diaphragm with spermicide; (c) cervical cap with spermicide; or (d) a contraceptive sponge with spermicide.

    Note: All other females must have been surgically sterilized for at least 6 months before Screening (proper documentation required), or be postmenopausal (defined as 24 months without menses before Screening, and an estradiol level of < 30 pg/mL and a plasma Follicle Stimulating Hormone (FSH) level > 40 IU/L at Screening).

  5. Must have a Body Mass Index (BMI) between 18 and 33 kg/m2 (inclusive).
  6. No clinically significant laboratory test results, as determined by the Investigator.
  7. Must be afebrile, with supine systolic BP of 90 to 140 mmHg, a supine diastolic Blood Pressure (BP) of 60 to 90 mmHg, and pulse rate of 40 to 110 bpm.
  8. Must have a normal or clinically acceptable 12-lead Electrocardiogram (ECG) at Screening. Male subjects must have a QTcF value ≤ 430 msec. Female subjects must have a QTcF value ≤ 450 msec.

Exclusion Criteria:

  1. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
  2. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study, or confounds the ability to interpret data from the study.
  3. Use of any prescribed systemic or topical medication (including but not limited to antibiotics, analgesics, anesthetics, etc.) prior to 30 days of the first dose administration, unless Sponsor agreement is obtained.
  4. Use of any non-prescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines) within 7 days of the first dose administration, unless Sponsor agreement is obtained.
  5. Any surgical or medical condition possibly affecting drug absorption, distribution, metabolism and excretion (e.g., bariatric procedure), or plans to have elective or medical procedures during the conduct of the trial. Subjects post cholecystectomy and post appendectomy may be included.
  6. Exposure to an investigational drug within 30 days prior to the first dose administration or 5 half-lives of that investigational drug, if known (whichever is longer).
  7. Donated blood or plasma prior to 4 weeks before the first dose administration to a blood bank or blood donation center.
  8. History of multiple drug allergies (i.e., two or more);
  9. History of drug abuse (as defined by the current version of the Diagnostic and Statistical Manual [DSM]) prior to 2 years before first dose administration, or a positive drug screen reflecting consumption of illicit drugs.
  10. History of alcohol abuse (as defined by the current version of the DSM) prior to 2 years before dosing, or a positive alcohol screen.
  11. Known to have hepatitis, or known to be a carrier of the Hepatitis B Surface Antigen (HBsAg), or Hepatitis C Virus Antibody (HCVAb), or have a positive result to the test for HBsAg, HCVAb, or Human Immunodeficiency Virus (HIV) antibodies at Screening.
  12. History of smoking or the use of nicotine containing products prior to 3 months of Screening by self reporting.
  13. Female subjects lactating or breastfeeding a child.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CC-292 SDD (Spray Dried Dispersion)300mg - Fasted Condition
Single oral dose of 300 mg CC-292 SDD under fasted conditions (100 mg SDD x 3 tablets)
Experimental: CC-292 SDD 300mg - Fed Condition
Single oral dose of 300 mg CC-292 SDD under fed conditions (100 mg SDD x 3 tablets)
Experimental: 375mg P22 - Fasted condition
Single oral dose of 375 mg P22 under fasted conditions (125 mg P22 x 3)
Experimental: 375mg P22 Fed Condition
Single oral dose of 375 mg P22 under fed conditions (125 mg P22 x 3)
Experimental: CC-292 SDD 100 mg Fasted Condition
Single oral dose of 100 mg CC-292 SDD under fasted conditions
Experimental: SDD plus OMP (Oral Omeprazole)
Single oral dose of 300 mg CC-292 SDD under fasted conditions (100 mg SDD x 3 tablets) in the presence of 40 mg
Experimental: P22 plus OMP
Single oral dose of 375 mg P22 under fasted conditions (125 mg P22 x 3) in the presence of 40 mg oral OMP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics - Cmax
Time Frame: 48 hours
Maximum observed concentration in plasma
48 hours
Pharmacokinetics - AUC 0-t
Time Frame: 48 hours
Area under the plasma concentration-time curve from time zero to the last measured time point
48 hours
Pharmacokinetics - AUC 0-24
Time Frame: 48 hours
Area under the plasma concentration-time curve to 24 hours post dose
48 hours
Pharmacokinetics - AUC 0-∞
Time Frame: 48 hours
Area under the plasma concentration-time curve from time zero extrapolated to infinity
48 hours
Pharmacokinetics - %AUCextrap
Time Frame: 48 hours
Percent Area under the plasma concentration-time curve extrapolated
48 hours
Pharmacokinetics - Frel
Time Frame: 48 hours
Relative bioavailability of the CC-292 SDD formulation compared to the reference P22 formulation
48 hours
Pharmacokinetics - Tmax
Time Frame: 48 hours
Time to Cmax
48 hours
Pharmacokinetics - λz
Time Frame: 48 hours
Terminal disposition rate constant
48 hours
Pharmacokinetics - t1/2
Time Frame: 48 hours
Terminal half-life
48 hours
Pharmacokinetics - CL/F
Time Frame: 48 hours
Apparent clearance
48 hours
Pharmacokinetics - Vz/F
Time Frame: 48 hours
Apparent volume of distribution
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events (AEs)
Time Frame: Approximatly 52 days
Number of subjects with adverse events
Approximatly 52 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2014

Primary Completion (Actual)

September 26, 2014

Study Completion (Actual)

September 26, 2014

Study Registration Dates

First Submitted

March 26, 2015

First Submitted That Met QC Criteria

April 29, 2015

First Posted (Estimate)

May 5, 2015

Study Record Updates

Last Update Posted (Actual)

August 13, 2020

Last Update Submitted That Met QC Criteria

August 11, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • CC-292-CP-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy Volunteers

Clinical Trials on CC-292

Search Similar Trials