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Radiolabeled Study of CC-122 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02234999
Recruitment Status : Completed
First Posted : September 9, 2014
Last Update Posted : March 28, 2016
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation

Brief Summary:
To evaluate the metabolism and excretion of [14C]-CC-122 in healthy male subjects

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: CC-122 Phase 1

Detailed Description:
This is a single-center, open-label study to evaluate the metabolism and excretion of [14C]-CC-122 following a single oral dose of [14C]-CC-122 in healthy male subjects. It is planned for 6 subjects to be enrolled; each subject will participate in a screening phase, a baseline phase, a treatment phase, and a follow up phone call. Blood, urine and fecal samples will be collected for analyses.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Official Title: A Phase 1, Single-center, Open-label Study to Evaluate the Metabolism and Excretion of [14C]-CC-122 in Healthy Male Subjects
Study Start Date : September 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Arm Intervention/treatment
Experimental: 3mg [14C]-CC-122 (Single Dose)
Single oral capsule of 3mg [14C]-CC-122. given as a suspension under fasting conditions on Day 1
Drug: CC-122
3mg [14C]-CC-122 will be administered as a single dose




Primary Outcome Measures :
  1. Total [14C]-radioactivity in biological matrices-Pharmacokinetics (PK) [ Time Frame: Up to 12 days ]
    Biological matrices (whole blood, plasma, urine and feces) will be collected and analyzed for total [14C]-radioactivity

  2. Cumulative excretion of total [14C]-radioactivity in urine and feces (PK) [ Time Frame: Up to 12 days ]
    Urine and feces will be collected and analyzed for measurement of [14C]-radioactivity

  3. Total [14C]-radioactivity whole blood-to-plasma ratios: PK [ Time Frame: Up to 8 days ]
    Blood samples will be collected and analyzed for measurement of [14C]-radioactivity

  4. Metabolite profiling/characterization in select biological matrices-PK [ Time Frame: Up to 12 dyas ]
    Biological matrices (plasma, urine, and fecal samples) will be collected and select samples will undergo metabolite profiling/characterization

  5. Peak (maximum) plasma concentration (Cmax) for total [14C]-radioactivity, [14C]-CC-122, and [14C]-metabolite(s), as appropriate PK [ Time Frame: Up to 12 days ]
    Blood samples will be collected and analyzed; Maximum observed plasma or whole blood concentration for up to 168 hours postdose will be calculated and reported as appropriate

  6. Area under the plasma concentration-time curve (AUC) for total [14C]-radioactivity, [14C]-CC-122, and [14C]-metabolite(s), as appropriate [ Time Frame: Up to 12 days ]
    Blood samples will be collected and analyzed; Area under the concentration-time curve from time zero up to 168 hours postdose will be calculated and reported as appropriate

  7. Time to maximum plasma concentration (Tmax) for total [14C]-radioactivity, [14C]-CC-122, and [14C]-metabolite(s), as appropriate [ Time Frame: Up to 12 days ]
    Blood samples will be collected and analyzed; Time to reach the observed maximum (peak) concentration will be calculated and reported as appropriate.

  8. Terminal elimination half-life (t1/2) for total [14C]-radioactivity, [14C]-CC-122, and [14C]-metabolite(s), as appropriate [ Time Frame: Up to 12 days ]
    Blood samples will be collected and analyzed; Terminal half-life will be calculated and reported as appropriate


Secondary Outcome Measures :
  1. The incidence, type, severity of adverse events (AE) [ Time Frame: Up to 28 days following dose; AEs will be collected and recorded from the time the subjects signs Informed Consent throughthe 28 day period following the of last dose of study drug ]
    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 regardless of etiology



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:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 1. Healthy adult male of any race and between 18 years of age to 55 years of age, inclusive, at the time of signing the informed consent document.

    2. Understand and voluntarily sign an informed consent document before any study related assessments/procedures are performed.

    3. Able to adhere to the study visit schedule and other protocol requirements. 4. Must practice true abstinence or agree to use a condom (a latex condom is recommended) during sexual contact with a pregnant female or a female of childbearing potential while participating in the study and for at least 28 days following discontinuation of investigational product, even if he has undergone a successful vasectomy.

    5. Must agree to abide by the CC 122 Pregnancy Prevention Risk Management Plan 6. Must have a body mass index between 18 and 33 kg/m2, inclusive, at screening.

    7. Must be healthy as determined by the Investigator on the basis of medical history, physical exam, clinical laboratory test results, vital signs, and 12-lead electrocardiogram at screening:

    • Must be afebrile (febrile is defined as ≥ 38.5°C or 101.3°F)
    • Supine systolic blood pressure must be in the range of 90 to 140 mmHg, supine diastolic blood pressure must be in the range of 50 to 90 mmHg, and pulse rate must be in the range of 40 to 110 bpm
    • Normal or clinically acceptable 12 lead electrocardiogram, with a QTcF value ≤ 430 msec

Exclusion Criteria:

  • 1. History of any clinically significant and relevant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies (including a known hypersensitivity to a member of the class of IMiDs®), or other major disorders.

    2. Any condition, including the presence of clinically significant laboratory abnormalities, which places the subject at unacceptable risk if he were to participate in the study.

    3. Any condition that confounds the ability to interpret data from the study. 4. Exposed to an investigational drug (new chemical entity) within 30 days preceding dose administration, or five half lives of that investigational drug, if known (whichever is longer).

    5. Participation in more than one other radiolabeled investigational drug study within 12 months prior to check in.

Note: The previous radiolabeled investigational drug must have been received more than 6 months prior to check in and the total planned exposure from this current study and the previous study must be within the recommended levels considered safe, per United States Code of Federal Regulations governing Protection of Human Subjects; radioactive drugs for certain research uses.

6. Exposure to significant radiation (for example, serial X-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring) within 12 months prior to check in.

7. Used any prescribed systemic or topical medication (including but not limited to analgesics, anesthetics, etc) within 30 days of dose administration.

8. Used any nonprescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines) within 14 days of dose administration.

9. Used cytochrome P450 3A inducers and/or inhibitors (including St. John's wort) within 30 days of dose administration.

10. Received a live vaccination within 90 days of dose administration. 11. Has any surgical or medical conditions possibly affecting absorption, distribution, metabolism, and/or elimination, for example, bariatric procedure, or plans to have elective or medical procedures performed during the conduct of the trial. Prior appendectomy is acceptable, but prior cholecystectomy would result in exclusion from the study.

12. Donated blood or plasma within 8 weeks before dose administration to a blood bank or blood donation center.

13. History of drug abuse (as defined by the current version of the Diagnostic and Statistical Manual) within 2 years before dose administration, or positive drug screening test reflecting consumption of illicit drugs.

14. History of alcohol abuse (as defined by the current version of the Diagnostic and Statistical Manual) within 2 years before dose administration, or positive alcohol screen.

15. Known to have serum hepatitis or known to be a carrier of hepatitis B surface antigen or hepatitis C antibodies, or have a positive result to the test for HIV antibodies at screening.

16. Smokes more than 10 cigarettes per day, or the equivalent in other tobacco products (self reported).

17. Part of the clinical site staff personnel or family members of the clinical site staff.

18. History of less than one to two bowel movements per day.


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): NCT02234999


Locations
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United States, Wisconsin
Covance Clinical Research Unit Inc
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Celgene Corporation
Investigators
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Study Director: Edward O'Mara, MD Celgene Corporation

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Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT02234999     History of Changes
Other Study ID Numbers: CC-122-CP-003
First Posted: September 9, 2014    Key Record Dates
Last Update Posted: March 28, 2016
Last Verified: March 2016

Keywords provided by Celgene Corporation:
Pharmacokinetics, Healthy Subjects