Clinical Pharmacology, Healthy Male Volunteer StudyPhase 1NCT02049528
Study to Evaluate Pharmacokinetics of Single Oral Doses of Formulated and Non-Formulated CC-122, and Food Effect Study
A Phase 1 study testing CC-122 in people with Clinical Pharmacology, Healthy Male Volunteer Study, run by Celgene at 1 site in United States.
Trial summary
The study is being conducted to compare how long 2 oral formulations (a reference and a test formulation) of CC-122 stays in the body, and whether taking the test formulations with a high-fat meal affects the absorption of that formulation. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Clinical Pharmacology, Healthy Male Volunteer Study
- What is being tested?
- CC-122
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2014to 8 Feb 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Development Services
Daytona Beach, Florida, 32117
About this study
Official title: 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
The study is being conducted to compare how long 2 oral formulations (a reference and a test formulation) of CC-122 stays in the body, and whether taking the test formulations with a high-fat meal affects the absorption of that formulation. There will be 3 dosing periods in the study, one for each formulation and one for the test formulation + meal. The subjects will be asked to fast for at least 10 hours before taking the capsule formulations. During one of the periods, the subject will be asked to eat a high-fat meal 30 minutes before being given the capsule to swallow. Subjects will be randomly (by chance) assigned to a treatment sequence which will determine the order in which the subject will receive the reference formulation, the test formulation, and the test formulation + high-fat meal. Blood samples will be taken at intervals during the study to assess the amount of drug at those time points. Blood samples will also be collected at certain time points to determine the levels of special proteins that may help explain how CC-122 work.
- Being tested
- CC-122
- Keywords
- Food Effect, Pharmacokinetic, Healthy, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-122Drug
CC-122
CC-122Drug
CC-122
CC-122Drug
CC-122
| Study group | Role | What they receive |
|---|---|---|
| 3 mg CC-122 reference capsule formulation | Experimental | 3 mg CC-122 reference capsule given by mouth with 240 mL of room temp tap water Receives: Drug: CC-122 |
| 3 mg CC-122 test capsule formulation | Experimental | 3 mg CC-122 test capsule give by mouth with 240 mL of room temp tap water Receives: Drug: CC-122 |
| 3 mg CC-122 test capsule + high fat meal | Experimental | 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 Receives: Drug: CC-122 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics - AUC
Area under the plasma concentration-time curve
Measured: up to about 21 days after first dosing
Pharmacokinetics - Cmax
Maximum observed concentration in plasma
Measured: up to about 21 days after first dosing
Pharmacokinetics - Tmax
Time to maximum concentration
Measured: up to about 21 days after first dosing
Pharmacokinetics - T1/2
Terminal half-life (T1/2)
Measured: up to about 21 days after first dosing
Pharmacokinetics - CL/F
Apparent total body clearance
Measured: up to about 21 days after first dosing
Pharmacokinetics - Vz/f
Apparent volume of distribution
Measured: up to about 21 days after first dosing
Secondary outcomes (1)
Safety and tolerability
Safety monitoring will be done by regular adverse event assessment, concomitant medication, clinical laboratory tests, physical exams, ECGs, and vital signs.
Measured: approximately 7-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study start16 Jan 2014
- Primary completion2 Feb 2014
- Study completion8 Feb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Pharmacology, Healthy Male Volunteer StudyStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edward O'Mara, MD, Study director, Celgene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02049528
- Sponsor's protocol ID
- CC-122-CP-001
- Status last verified
- Nov 2019
- First submitted
- 28 Jan 2014
- Last updated
- 12 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02049528
- Acronym / sponsor ID
- CC-122-CP-001
- Keywords
- Food Effect, Pharmacokinetic, Healthy, Male
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2014 (actual)
- Primary completion
- 2 Feb 2014 (actual)
- Study completion
- 8 Feb 2014 (actual)
- First posted
- 30 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is being conducted to compare how long 2 oral formulations (a reference and a test formulation) of CC-122 stays in the body, and whether taking the test formulations with a high-fat meal affects the absorption of that formulation. There will be 3 dosing periods in the study, one for each formulation and one for the test formulation + meal. The subjects will be asked to fast for at least 10 hours before taking the capsule formulations. During one of the periods, the subject will be asked to eat a high-fat meal 30 minutes before being given the capsule to swallow. Subjects will be randomly (by chance) assigned to a treatment sequence which will determine the order in which the subject will receive the reference formulation, the test formulation, and the test formulation + high-fat meal. Blood samples will be taken at intervals during the study to assess the amount of drug at those time points. Blood samples will also be collected at certain time points to determine the levels of special proteins that may help explain how CC-122 work.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3 mg CC-122 reference capsule formulation | Experimental | Drug: CC-1223 mg CC-122 reference capsule given by mouth with 240 mL of room temp tap water |
| 3 mg CC-122 test capsule formulation | Experimental | Drug: CC-1223 mg CC-122 test capsule give by mouth with 240 mL of room temp tap water |
| 3 mg CC-122 test capsule + high fat meal | Experimental | Drug: CC-1223 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects must satisfy ALL of the following criteria to be enrolled in the study:
Key exclusion criteria (16 listed)
- The presence of ANY of the following will exclude a subject from enrollment:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CC-122CC-122 | Drug | 3 mg CC-122 reference capsule formulation |
| CC-122CC-122 | Drug | 3 mg CC-122 test capsule formulation |
| CC-122CC-122 | Drug | 3 mg CC-122 test capsule + high fat meal |
Primary outcome
Pharmacokinetics - AUC
Time frame: up to about 21 days after first dosing
Area under the plasma concentration-time curve
Pharmacokinetics - Cmax
Time frame: up to about 21 days after first dosing
Maximum observed concentration in plasma
Pharmacokinetics - Tmax
Time frame: up to about 21 days after first dosing
Time to maximum concentration
Pharmacokinetics - T1/2
Time frame: up to about 21 days after first dosing
Terminal half-life (T1/2)
Pharmacokinetics - CL/F
Time frame: up to about 21 days after first dosing
Apparent total body clearance
Pharmacokinetics - Vz/f
Time frame: up to about 21 days after first dosing
Apparent volume of distribution
1 secondary outcome
Safety and tolerability
Time frame: approximately 7-8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward O'Mara, MD study director
Celgene
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CC-122 in people with Clinical Pharmacology, Healthy Male Volunteer Study, run by Celgene at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics - AUC (time frame: up to about 21 days after first dosing). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2019.