Safety and Pharmacokinetics in Healthy Volunteer SubjectsPhase 1AME/FENCT01611467
A Phase 1 Open-Label Study to Evaluate the Metabolism and Excretion of CC-223 and the Effect of Food on the Pharmacokinetics of CC-223 in Healthy Male Adult Subjects
A Phase 1 study testing CC-223 in people with Safety and Pharmacokinetics in Healthy Volunteer Subjects, run by Celgene at 1 site in United States.
Trial summary
Part 1: To characterize the biotransformation and excretion of CC-223 following a single 20-mg oral dose of CC-223 capsule containing a microtracer of [14C]-CC-223 solution in healthy male subjects; and to evaluate the tolerability of CC-223 after a single 20-mg oral dose of CC-223 capsule containing a microtracer of… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Safety and Pharmacokinetics in Healthy Volunteer Subjects
- What is being tested?
- CC-223
- 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
- 1 Jun 2012to 1 Jul 2012
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must understand and voluntarily sign a written informed consent document (ICD) prior to any study-related procedures being performed and be able to adhere to restrictions and examination schedules.
- Must be able to communicate with the investigator and clinical staff and to understand and comply with the requirements of the study.
- Must be a male 18 to 55 years of age (inclusive) at the time of signing the ICD, with a body mass index (BMI) (weight [kg]/(height [m2]) between 18 and 33 kg/m2 (inclusive) and weight between 60 and 100 kg (132 to 220 lbs; inclusive)
- Must be healthy (at Screening and Day -1) as determined by the investigator on the basis of medical history, physical examination, clinical laboratory safety test results, vital signs, and 12 lead electrocardiograms (ECGs).
- Vital signs (systolic and diastolic blood pressure, pulse rate, and oral body temperature) will be assessed in the supine position after the subject has rested for at least 5 minutes.
- Subject must be afebrile (febrile is defined as ≥ 38.5ºC or 101.3 Fahrenheit)
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- Systolic blood pressure in the range of 90 to 140 mmHg, diastolic blood pressure in the range of 60 to 90 mmHg, and pulse rate in the range of 45 to 100 bpm
- Screening fasting plasma glucose value within the normal limits of the institution and HbA1C < 6%
- Subjects (with or without vasectomy) must agree to use barrier contraception (ie, latex condom or any non-latex condom not made out of natural [animal] membrane [eg., polyurethane]) and one other method (eg., spermicide) when engaging in sexual activity with woman of child-bearing potential during study conduct, and for 90 days after the last dose of study medication.
- Must agree to refrain from donating blood or plasma (other than for this study) while participating in this study and for at least 28 days after the last dose of study drug.
Who cannot join
- Recent history (ie, within 3 years) of any clinically significant neurological, gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, endocrine, hematological, dermatological, psychological, or other major disorders.
- 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 7 days of the first dose administration (with the exception of vitamin/mineral supplements).
- Subject used 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, or plans to have elective or medical procedures during the conduct of the trial.
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- Exposure to an investigational drug (new chemical entity) within 90 days prior to the first dose administration.
- Donation of blood or plasma within 60 days prior to the first dose administration.
- History of multiple (ie, 2 or more) drug allergies.
- Any clinical significant allergic disease (excluding non-active hay fever), excluding non-active seasonal allergies and childhood asthma cleared for at least 3 years
- History of drug abuse within 2 years prior to first dosing, or positive urine drug screening test due to illicit drugs.
- History of alcohol abuse within 2 years prior to dosing, or positive alcohol screen.
- Smokes more than 10 cigarettes, or consumes the equivalent in tobacco, per day.
- Known to have, or tests positive for, active or chronic hepatitis B or hepatitis C, or human immunodeficiency virus (HIV) antibodies
- Received vaccination (excluding seasonal flu vaccination) within 90 days of the study drug administration.
- For Part 1 Only: Prior exposure to radioactive investigational drugs within 6 months prior to check in, and prior exposure to work-related, diagnostic or therapeutic radiation within 12 months prior to check in.
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Research Unit, Inc
Madison, Wisconsin, 53704
About this study
Part 1: To characterize the biotransformation and excretion of CC-223 following a single 20-mg oral dose of CC-223 capsule containing a microtracer of [14C]-CC-223 solution in healthy male subjects; and to evaluate the tolerability of CC-223 after a single 20-mg oral dose of CC-223 capsule containing a microtracer of [14C]-CC-223 solution in healthy male adult subjects Part 2: To evaluate the effect of a high-fat meal on the pharmacokinetics (PK) of CC-223 following a single 20-mg oral dose of CC-223 tablet; To evaluate the effect of a high-fat meal on the PK of M1, the principal pharmacologically-active metabolite, following a single 20-mg oral dose of CC-223 tablet; and to evaluate the tolerability of CC-223 after a single 20-mg oral dose of CC-223 tablet in healthy male adult subjects.
Read the detailed description
This will be a single-center, 2-part, open-label, randomized (Part 1 only), 2-treatment study in healthy adult males (n = 18). Within no more than 28 days (Day -28) prior to the start of Part 1 or Part 2, subjects will undergo routine screening procedures including physical examination, 12-lead electrocardiograms (ECGs), vital signs, clinical laboratory safety tests (serum chemistry, hematology, and urinalysis), serology screen, fasting glucose levels (including HbA1C) and drug and alcohol screen.
In Part 1, subjects (n = 6) will receive Treatment A (Cohort 1) under fasted conditions. Treatment A: A single 20-mg oral dose of CC-223 capsule containing a microtracer of [14C]- CC-223 solution. For Part 1, subjects will be domiciled at the study center from Day -1 until the morning of Day 8. Upon satisfactory safety review and completion of study-related procedures, subjects will be discharged from the study center on the morning of Day 8.
Part 2 will be a 2-period crossover study; in Period 1, subjects (n = 12) will be randomized to receive an oral 20 mg dose of CC-223 (Treatment B) under fed (n = 6) or fasted (n = 6) conditions. In Period 2, subjects will receive Treatment B under converse conditions based on treatment assignment in Period 1 (Cohort 2 or 3). Fed subjects will be served a standard high fat meal (breakfast), or its equivalent, and must be consumed within 30 minutes of serving. Dosing must occur 30 minutes (±5 minutes) after serving a subject breakfast. All subjects will remain fasted until 4 hours post dose. Subjects will be domiciled at the study center from Day -1 until the morning of Day 5 of each period. Subjects will be discharged from the study center on the morning of Day 5 upon satisfactory safety review and completion of study-related procedures. Periods 1 and 2 will be separated by a washout period of at least 7 days (no more than 10 days) from prior dose to the next dose. In certain instances, a longer washout may be acceptable if previously agreed to by the principal investigator (PI) and Celgene.
All subjects will return to the clinic within 7 to 10 days after the day of discharge in Part 1 or Period 2 of Part 2 for follow-up safety assessments.
- Being tested
- CC-223
- Keywords
- CC-223, safety, tolerability, pharmacokinetic, AME (Absorption, Metabolism, and Excretion), FE (Food Effect)
- Medical subject headings
- Mineralocorticoid Excess Syndrome, Apparent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-223Drug
20 mg oral CC-223 capsule containing a microtracer of [14C]-CC-223 solution
CC-223Drug
20-mg oral CC-223 tablet under fasting or fed conditions
| Study group | Role | What they receive |
|---|---|---|
| 20 mg oral CC-223 with microtracer | Experimental | A single 20-mg oral dose of CC-223 capsule containing a microtracer of [14C]-CC-223 solution Receives: Drug: CC-223 |
| 20 mg oral CC-223 fasting | Experimental | A single 20-mg oral dose of CC-223 tablet under fasting conditions Receives: Drug: CC-223 |
| 20 mg oral CC-223 fed | Experimental | A single 20-mg oral dose of CC-223 tablet under fed conditions Receives: Drug: CC-223 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total radioactivity
Total [14C]-radioactivity in whole blood, plasma, urine and feces
Measured: Up to 8 days
Cumulative excretion of radioactivity
Cumulative excretion of Total [14C]-radioactivity (as fraction of radioactive dose) in urine and feces
Measured: Up to 8 days
Total radioactivity ratios
Total [14C]-radioactivity whole blood-to-plasma ratios
Measured: Up to 8 days
Metabolite concentration
Concentration of CC-223 and M1 metabolite (O-desmethyl-CC-223) in plasma, urine, and feces samples collected up to 14 times from the day prior to dosing to 8 days after dosing.
Measured: Up to 8 days
Cmax
Cmax: Maximum observed concentration in plasma
Measured: Up to 10 days
Tmax
Tmax: Time to maximum concentration
Measured: Up to 10 days
AUC
AUC: Area under the plasma concentration-time curve
Measured: Up to 10 days
t1/2
t1/2: Terminal half-life
Measured: Up to 10 days
Secondary outcomes (1)
Adverse Events
Number of participants with adverse events
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2012 (estimated)
- Study start1 Jun 2012
- Primary completion1 Jul 2012
- Study completion1 Jul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety and Pharmacokinetics in Healthy Volunteer SubjectsStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria Palmisano, M.D., Study director, Celgene Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01611467
- Sponsor's protocol ID
- CC-223-CP-002
- Acronym
- AME/FE
- Status last verified
- Nov 2019
- First submitted
- 25 May 2012
- 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 Study to Evaluate the Metabolism and Excretion of CC-223 and the Effect of Food on the Pharmacokinetics of CC-223 in Healthy Male Adult Subjects
- ClinicalTrials.gov ID
- NCT01611467
- Acronym / sponsor ID
- AME/FE / CC-223-CP-002
- Keywords
- CC-223, safety, tolerability, pharmacokinetic, AME (Absorption, Metabolism, and Excretion), FE (Food Effect)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2012 (actual)
- Primary completion
- 1 Jul 2012 (actual)
- Study completion
- 1 Jul 2012 (actual)
- First posted
- 5 Jun 2012 (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.
Part 1: To characterize the biotransformation and excretion of CC-223 following a single 20-mg oral dose of CC-223 capsule containing a microtracer of [14C]-CC-223 solution in healthy male subjects; and to evaluate the tolerability of CC-223 after a single 20-mg oral dose of CC-223 capsule containing a microtracer of [14C]-CC-223 solution in healthy male adult subjects Part 2: To evaluate the effect of a high-fat meal on the pharmacokinetics (PK) of CC-223 following a single 20-mg oral dose of CC-223 tablet; To evaluate the effect of a high-fat meal on the PK of M1, the principal pharmacologically-active metabolite, following a single 20-mg oral dose of CC-223 tablet; and to evaluate the tolerability of CC-223 after a single 20-mg oral dose of CC-223 tablet in healthy male adult subjects.
Detailed description
This will be a single-center, 2-part, open-label, randomized (Part 1 only), 2-treatment study in healthy adult males (n = 18). Within no more than 28 days (Day -28) prior to the start of Part 1 or Part 2, subjects will undergo routine screening procedures including physical examination, 12-lead electrocardiograms (ECGs), vital signs, clinical laboratory safety tests (serum chemistry, hematology, and urinalysis), serology screen, fasting glucose levels (including HbA1C) and drug and alcohol screen.
In Part 1, subjects (n = 6) will receive Treatment A (Cohort 1) under fasted conditions. Treatment A: A single 20-mg oral dose of CC-223 capsule containing a microtracer of [14C]- CC-223 solution. For Part 1, subjects will be domiciled at the study center from Day -1 until the morning of Day 8. Upon satisfactory safety review and completion of study-related procedures, subjects will be discharged from the study center on the morning of Day 8.
Part 2 will be a 2-period crossover study; in Period 1, subjects (n = 12) will be randomized to receive an oral 20 mg dose of CC-223 (Treatment B) under fed (n = 6) or fasted (n = 6) conditions. In Period 2, subjects will receive Treatment B under converse conditions based on treatment assignment in Period 1 (Cohort 2 or 3). Fed subjects will be served a standard high fat meal (breakfast), or its equivalent, and must be consumed within 30 minutes of serving. Dosing must occur 30 minutes (±5 minutes) after serving a subject breakfast. All subjects will remain fasted until 4 hours post dose. Subjects will be domiciled at the study center from Day -1 until the morning of Day 5 of each period. Subjects will be discharged from the study center on the morning of Day 5 upon satisfactory safety review and completion of study-related procedures. Periods 1 and 2 will be separated by a washout period of at least 7 days (no more than 10 days) from prior dose to the next dose. In certain instances, a longer washout may be acceptable if previously agreed to by the principal investigator (PI) and Celgene.
All subjects will return to the clinic within 7 to 10 days after the day of discharge in Part 1 or Period 2 of Part 2 for follow-up safety assessments.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 20 mg oral CC-223 with microtracer | Experimental | Drug: CC-223A single 20-mg oral dose of CC-223 capsule containing a microtracer of [14C]-CC-223 solution |
| 20 mg oral CC-223 fasting | Experimental | Drug: CC-223A single 20-mg oral dose of CC-223 tablet under fasting conditions |
| 20 mg oral CC-223 fed | Experimental | Drug: CC-223A single 20-mg oral dose of CC-223 tablet under fed conditions |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Must understand and voluntarily sign a written informed consent document (ICD) prior to any study-related procedures being performed and be able to adhere to restrictions and examination schedules.
- Must be able to communicate with the investigator and clinical staff and to understand and comply with the requirements of the study.
- Must be a male 18 to 55 years of age (inclusive) at the time of signing the ICD, with a body mass index (BMI) (weight [kg]/(height [m2]) between 18 and 33 kg/m2 (inclusive) and weight between 60 and 100 kg (132 to 220 lbs; inclusive)
- Must be healthy (at Screening and Day -1) as determined by the investigator on the basis of medical history, physical examination, clinical laboratory safety test results, vital signs, and 12 lead electrocardiograms (ECGs).
- Subjects (with or without vasectomy) must agree to use barrier contraception (ie, latex condom or any non-latex condom not made out of natural [animal] membrane [eg., polyurethane]) and one other method (eg., spermicide) when engaging in sexual activity with woman of child-bearing potential during study conduct, and for 90 days after the last dose of study medication.
Key exclusion criteria (16 listed)
- Recent history (ie, within 3 years) of any clinically significant neurological, gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, endocrine, hematological, dermatological, psychological, or other major disorders.
- 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 7 days of the first dose administration (with the exception of vitamin/mineral supplements).
- Subject used any metabolic enzyme inhibitors or inducers (ie, CYP3A inducers and inhibitors or St. John's Wort) within 30 days of the first dose administration.
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-22320 mg oral CC-223 capsule containing a microtracer of [14C]-CC-223 solution | Drug | 20 mg oral CC-223 fasting, 20 mg oral CC-223 fed |
| CC-22320-mg oral CC-223 tablet under fasting or fed conditions | Drug | 20 mg oral CC-223 with microtracer |
Primary outcome
Total radioactivity
Time frame: Up to 8 days
Total [14C]-radioactivity in whole blood, plasma, urine and feces
Cumulative excretion of radioactivity
Time frame: Up to 8 days
Cumulative excretion of Total [14C]-radioactivity (as fraction of radioactive dose) in urine and feces
Total radioactivity ratios
Time frame: Up to 8 days
Total [14C]-radioactivity whole blood-to-plasma ratios
Metabolite concentration
Time frame: Up to 8 days
Concentration of CC-223 and M1 metabolite (O-desmethyl-CC-223) in plasma, urine, and feces samples collected up to 14 times from the day prior to dosing to 8 days after dosing.
Cmax
Time frame: Up to 10 days
Cmax: Maximum observed concentration in plasma
Tmax
Time frame: Up to 10 days
Tmax: Time to maximum concentration
AUC
Time frame: Up to 10 days
AUC: Area under the plasma concentration-time curve
t1/2
Time frame: Up to 10 days
t1/2: Terminal half-life
1 secondary outcome
Adverse Events
Time frame: Up to 30 days
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.
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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.
Maria Palmisano, M.D. study director
Celgene Corporation
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-223 in people with Safety and Pharmacokinetics in Healthy Volunteer Subjects, 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 10 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?
Total radioactivity (time frame: Up to 8 days). The study lists 8 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.