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CC-223 and Ketoconazole Drug-Drug Interaction Study

Sponsor
Celgene (Industry)
Overall Status
Completed
CT.gov ID
NCT01896323
Collaborator
(none)
14
Enrollment
2
Arms
1
Actual Duration (Months)

Study Details

Study Description

Brief Summary

This is a single-center open-label study to compare how CC-223 (the study drug being investigated) interacts with the drug ketoconazole.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

This is a 2 period study, which lasts about 6 weeks long. About 14 males will be entered into the study, during which they will receive the study drug (a single dose of 20 mg CC-223) 400 mg ketoconazole.

Study Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
An Open-Label, Two-Period, Fixed-Sequence Study to Evaluate the Effect of Multiple Doses of Ketoconazole on the Single Dose Pharmacokinetics of CC-223 in Healthy Adult Male Subjects
Actual Study Start Date :
Jul 1, 2013
Actual Primary Completion Date :
Aug 1, 2013
Actual Study Completion Date :
Aug 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: CC-223

CC-223 administration on study day 1 of Period 1 and study day 5 of Period 2

Drug: CC-223
CC-223 20 mg tablets
Active Comparator: Ketokonazole

Ketoconazole administration on study days 1 through 8 of Period 2

Drug: Ketoconazole
Ketoconazole 400 mg tablets
Other Names:
  • Nizoral

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics [up to 96 hours post dose]

      AUC-area under the plasma concentration-time curve;

    2. Pharmacokinetics [up to 96 hours post dose]

      Cmax-maximum observed plasma concentration

    3. Pharmacokinetics [up to 96 hours post dose]

      Tmax - Time to maximum observed plasma concentration

    4. Pharmacokinetics [up to 96 hours post dose]

      t½ - terminal elimination half-life in plasma

    Secondary Outcome Measures

    1. Adverse Events [Up to 28 days after last dose of study drug]

      Number of subjects with adverse events

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Must understand and voluntarily sign a written informed consent form before participation.

    2. Must be able to communicate with the study doctor, understand and comply with the requirements of the study, and agree to adhere to restrictions and examination schedules.

    3. Healthy male subject of any race between 18 to 65 years of age, and in good health as determined by a physical examination.

    • For males: Agree to use barrier contraception not made of natural (animal) membrane (for example, latex or polyurethane condoms are acceptable) when engaging in sexual activity with a female of child-bearing potential while on study medication, and for at least 28 days after the last dose of study medication.

    1. Must have a body mass index between 18 and 33 kilograms/meter squared.

    2. Clinical laboratory tests must be within normal limits or acceptable to the study doctor.

    3. Must not have a fever, with a blood pressure between 90/50 to 140/90 millimeters of mercury, and pulse rate: between 40 to 110 beats per minute.

    4. Must have a normal or clinically acceptable 12-lead electrocardiogram.

    Exclusion Criteria:

    1. History of any clinically significant and relevant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, or other major disorders.

    2. Any condition which places the subject at unacceptable risk if he were to participate in the study, or confounds the ability to interpret data from the study.

    3. Used any prescribed or topical medication within one month before the first dose of study drug, unless consultation between the sponsor and the study doctor.

    4. Used any non-prescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines) within 2 weeks (30 days for St. John's Wort®) of the first dose administration, unless sponsor agreement is obtained.

    5. Has any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism and excretion of the study drug, for example, bariatric procedure.

    6. Donated blood or plasma within 2 months before the first dose of study drug.

    7. History of drug abuse within 2 years before dosing, or a positive drug screening test reflecting consumption of illicit drugs.

    8. History of alcohol abuse within 2 years before dosing, or positive alcohol screen.

    9. Known to have serum hepatitis or known to be a carrier of the hepatitis B surface antigen, or hepatitis C antibody, or have a positive result to the test for Human Immune virus antibodies at Screening.

    10. Exposed to an investigational drug within one month 30 days before the first dose of study drug.

    11. Smoke more than 10 cigarettes per day, or the equivalent in other tobacco products.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Celgene

    Investigators

    • Study Director: Edward O'Mara, MD, Celgene Corporation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Celgene
    ClinicalTrials.gov Identifier:
    NCT01896323
    Other Study ID Numbers:
    • CC-223-CP-003
    First Posted:
    Jul 11, 2013
    Last Update Posted:
    Nov 12, 2019
    Last Verified:
    Nov 1, 2019
    Additional relevant MeSH terms:
    Ketoconazole

    Study Results

    No Results Posted as of Nov 12, 2019