- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02049528
Study to Evaluate Pharmacokinetics of Single Oral Doses of Formulated and Non-Formulated CC-122, and Food Effect Study
A Phase 1, Open-Label, Randomized, Crossover Study To Evaluate The Pharmacokinetics Of Single Oral Doses Of Formulated And Non-Formulated CC-122 Capsules And The Effect Of Food On The Pharmacokinetics Of CC-122 In Healthy Adult Male Subjects
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Florida
-
Daytona Beach, Florida, United States, 32117
- Covance Clinical Development Services
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Subjects must satisfy ALL of the following criteria to be enrolled in the study:
- Must understand and voluntarily sign a written Informed Consent Document prior to any study-related assessments/procedures being performed and be able to adhere to restrictions and examination schedules.
- Must be able to communicate with the Investigator and to understand and adhere to the study visit schedule and other protocol requirements.
- Must be a male of any race, aged 18 years of age to 65 years of age (inclusive) at the time of signing the Informed Consent Document.
- Has a body mass index (BMI = weight [kilograms (kg)]/(height [m2])) between 18 and 33 kg/m2 (inclusive).
Must be healthy as determined by the Investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiograms.
- Must be afebrile (febrile is defined as body temperature ≥ 38.5 °Celsius or 101.3° Fahrenheit).
- Systolic blood pressure must be in the range of 90 to 140 millimeters of mercury (mmHg), diastolic blood pressure must be in the range of 50 to 90 mmHg, and pulse rate must be in the range of 45 to 110 beats per minute (bpm).
- QT interval (Fridericia correction factor) value ≤ 430 milliseconds as measured by an electrocardiogram.
- Screening and baseline fasting blood glucose must be ≤ 100 milligrams per deciliter (mg/dL) or < 5.6 millimoles per liter (mmol/L), and glycosylated hemoglobin < 6%.
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 child-bearing potential while participating in this study, during dose interruptions and for at least 28 days following study drug discontinuation, even if he has undergone a successful vasectomy.
True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject [Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception].
- Must agree to abide by the CC-122 Pregnancy Prevention Risk Management Plan.
Exclusion Criteria:
The presence of ANY of the following will exclude a subject from enrollment:
- History (ie, within 3 years) of any clinically significant neurological, gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, endocrine, hematological, dermatological, psychological, or other major disorders, or known hypersensitivity to a member of the class of immune-mediated inflammatory disease (IMiDs®).
- Any condition, including the presence of laboratory abnormalities, 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.
- Use of any prescribed systemic or topical medication within 30 days of the first dose.
- Use of any non-prescribed systemic or topical medication (including herbal medicines) within 14 days of the first dose administration (with the exception of vitamin/mineral supplements).
- Use of any metabolic enzyme inhibitors or inducers (ie, CYP3A inducers and inhibitors, or St. John's wort) within 30 days of the first dose administration.
- Presence of any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism and excretion, eg, bariatric procedure. Appendectomy and cholecystectomy are acceptable.
- Donated blood or plasma within 8 weeks before the first dose administration.
- History of drug abuse (as defined by the current version of the Diagnostic and Statistical Manual [DSM]) within 2 years before dosing, or positive drug screening test reflecting consumption of illicit drugs).
- History of alcohol abuse (as defined by the current version of the DSM) within 2 years before dosing, or positive alcohol screen.
- Known to have serum hepatitis or known to be a carrier of the hepatitis B surface antigen (HBsAg), or hepatitis C antibody, or have a positive result to the test for Human Immunodeficiency Virus antibodies at Screening.
- Exposed 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).
- Smoke more than 10 cigarettes per day, or the equivalent in other tobacco products (self reported).
- Subject has a history of multiple drug allergies (ie, 2 or more).
- Subject has any clinical significant allergic disease (excluding non-active hay fever), excluding non-active seasonal allergies and childhood asthma cleared for at least 3 years prior to screening.
- Subject received a live vaccine within 90 days of the study drug administration.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 3 mg CC-122 reference capsule formulation
3 mg CC-122 reference capsule given by mouth with 240 mL of room temp tap water
|
CC-122
|
Experimental: 3 mg CC-122 test capsule formulation
3 mg CC-122 test capsule give by mouth with 240 mL of room temp tap water
|
CC-122
|
Experimental: 3 mg CC-122 test capsule + high fat meal
3 mg CC-122 test capsule given by mouth with 240 mL of room temp tap water approximately 5 minutes after eating a high-fat meal
|
CC-122
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics - AUC
Time Frame: up to about 21 days after first dosing
|
Area under the plasma concentration-time curve
|
up to about 21 days after first dosing
|
Pharmacokinetics - Cmax
Time Frame: up to about 21 days after first dosing
|
Maximum observed concentration in plasma
|
up to about 21 days after first dosing
|
Pharmacokinetics - Tmax
Time Frame: up to about 21 days after first dosing
|
Time to maximum concentration
|
up to about 21 days after first dosing
|
Pharmacokinetics - T1/2
Time Frame: up to about 21 days after first dosing
|
Terminal half-life (T1/2)
|
up to about 21 days after first dosing
|
Pharmacokinetics - CL/F
Time Frame: up to about 21 days after first dosing
|
Apparent total body clearance
|
up to about 21 days after first dosing
|
Pharmacokinetics - Vz/f
Time Frame: up to about 21 days after first dosing
|
Apparent volume of distribution
|
up to about 21 days after first dosing
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and tolerability
Time Frame: approximately 7-8 weeks
|
Safety monitoring will be done by regular adverse event assessment, concomitant medication, clinical laboratory tests, physical exams, ECGs, and vital signs.
|
approximately 7-8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Edward O'Mara, MD, Celgene
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CC-122-CP-001
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.
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