Healthy VolunteerPhase 1NCT03340662
Study Evaluating the Effects of Food, Cytochrome P450 Inhibition and Induction on the Pharmacokinetics of CC-122
A Phase 1 study testing CC-122, Itraconazole and Fluvoxamine in people with Healthy Volunteer, run by Celgene at 1 site in United States.
Trial summary
This is a phase 1 open-label 4-part study to evaluate the effect of food, cytochrome P450 inhibition and induction on the pharmacokinetics of CC 122 in healthy adult subjects. Approximately 81 subjects will be enrolled. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- CC-122, Itraconazole and Fluvoxamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2017to 27 Jan 2018
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must satisfy the following criteria to be enrolled in the study:
- Subject must understand and voluntarily sign an Informed Consent Form (ICF) prior to any study-related assessments/procedures being conducted.
- Subject is ≥ 18 and ≤ 55 years of age at the time of signing the ICF.
- Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
- Subject is in good health as determined by a physical exam at screening.
- Subject agrees to abide by the requirements and restrictions outlined in the CC-122 Pregnancy Prevention Plan for Subjects in Clinical Trials.
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- Female subjects NOT of childbearing potential must:
- Have been surgically sterilized (hysterectomy or bilateral oophorectomy; proper documentation required) at least 6 months before screening, or be postmenopausal (defined as 24 consecutive months without menses before screening, with a follicle-stimulating hormone [FSH] level of > 40 IU/L at screening).
- Male subjects must:
- Practice true abstinence2 (which must be reviewed on a monthly basis, as applicable, and source documented) or agree to use a barrier method of birth control (condoms not made out of natural [animal] membrane [latex condoms are recommended]) during sexual contact with a pregnant female or female of childbearing potential (FCBP)3 while participating in the study, during dose interruptions, and for at least 90 days after the last dose of Investigational Product (IP), even if he has undergone a successful vasectomy.
- Subject has body mass index (BMI) ≥ 18 and ≤ 33 kg/m2 at screening.
- Subject has clinical laboratory safety test results that are within normal limits or
- considered not clinically significant by the Investigator. Platelet count, absolute neutrophil count, and absolute lymphocyte count must be above the lower limit of normal at screening.
- Subject is afebrile, with supine systolic blood pressure (BP) ≥ 90 and ≤ 140 mmHg, supine diastolic BP ≥ 50 and ≤ 90 mmHg, and pulse rate ≥ 40 and ≤ 110 bpm at screening.
- Subject has a normal or clinically acceptable 12-lead ECG at screening. In addition:
- If male, subject has a QTcF value ≤ 430 msec at screening.
- If female, subject has a QTcF value ≤ 450 msec at screening.
Who cannot join
- The presence of any of the following will exclude a subject from enrollment:
- Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
- Subject has any condition that confounds the ability to interpret data from the study.
- Subject has any hypersensitivity, allergy, or other contraindication to the components of the CC-122, itraconazole, fluvoxamine, or rifampin formulations used in this study (see IB and product labels for relevant information).
- Subject is a female of childbearing potential, pregnant, or breastfeeding.
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- Subject was exposed to an investigational drug (new chemical entity) within 30 days preceding the first dose administration, or five half-lives of that investigational drug, if known (whichever is longer).
- Subject has used any prescribed systemic or topical medication (including but not limited to analgesics, anesthetics, etc) within 30 days or 5 terminal half-lives (whichever is longer) prior to the first dose administration.
- Subject has used any non-prescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines) within 14 days prior to the first dose administration.
- Subject has used CYP3A and/or CYP1A2 inducers and/or inhibitors (including St. John's wort) within 30 days prior to the first dose administration.
- Subject has any surgical or medical condition possibly affecting drug absorption, distribution, metabolism and excretion, eg, bariatric procedure. Appendectomy and cholecystectomy are acceptable.
- Subject donated blood or plasma within 8 weeks before the first dose administration to a blood bank or blood donation center.
- Subject has a history of drug abuse (as defined by the current version of the Diagnostic and Statistical Manual [DSM]) within 2 years before the first dose administration, or positive drug screening test reflecting consumption of illicit drugs.
- Subject has a history of alcohol abuse (as defined by the current version of the DSM) within 2 years before the first dose administration, or positive alcohol screen.
- Subject has a CYP1A2*1 allele or a CYP3A4*22 allele (PARTS 2, 3, AND 4 ONLY).
- Subject is known to have serum hepatitis or known to be a carrier of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV Ab), or have a positive result to the test for human immunodeficiency virus (HIV) antibodies at screening.
- Subject smokes > 10 cigarettes per day, or the equivalent in other tobacco products (self-reported).
- Subject has received immunization with a live or live attenuated vaccine within 2 months prior to administration of the first dose of IP or is planning to receive immunization with a live or live attenuated vaccine for 2 months after administration of the last dose of IP.
- Subject is part of the clinical staff personnel or a family member of the clinical site staff.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, 4-Part Study to Evaluate the Effect of Food, Cytochrome P 450 Inhibition and Induction on the Pharmacokinetics of CC 122 in Healthy Adult Subjects
This is a phase 1 open-label 4-part study to evaluate the effect of food, cytochrome P450 inhibition and induction on the pharmacokinetics of CC 122 in healthy adult subjects. Approximately 81 subjects will be enrolled. There will be approximately 24 subjects in Part 1 and approximately 19 subjects in Parts 2, 3, and 4, respectively. Subjects may participate in 1 part only.
Read the detailed description
This study will consist of 4 parts. Each part has two periods. The parts may be conducted in any order. Subjects may participate in 1 part only.
Each subject will participate in a screening phase, a baseline phase in each study period, a treatment phase in each study period and a follow-up telephone call. Subjects will be screened for eligibility. Eligible subjects will return to the study center on Day -1 of Period 1 and will remain at the study center until the last day of Period 2.
Part 1: On Day 1 of Period 1, eligible subjects will be randomized to 1 of 2 sequences. On Day 1 of each study period, each subject will receive 1 of 2 treatments according to the sequence in which he or she is randomized.
In Part 2, subjects will receive a single dose of CC-122 in Period 1 and, following an appropriate washout, multiple doses of itraconazole plus one dose of itraconazole with CC-122 in Period 2.
In Part 3, subjects will receive a single dose of CC-122 in Period 1 and, following an appropriate washout, multiple doses of fluvoxamine plus one dose of fluvoxamine with CC-122 in Period 2.
In Part 4, subjects will receive a single dose of CC-122 in Period 1 and, following an appropriate washout, multiple doses of rifampin plus one dose of rifampin with CC-122 in Period 2.
- Conditions
- Healthy Volunteer
- Being tested
- CC-122, Itraconazole, Fluvoxamine, Rifampin
- Keywords
- Healthy Volunteer, CC-122, Adult, Phase 1, CYTOCHROME P450
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-122Drug
CC-122
ItraconazoleDrug
CYP3A Inhibitor
FluvoxamineDrug
CYP1A2 Inhibitor
RifampinDrug
CYP3A Inducer
| Study group | Role | What they receive |
|---|---|---|
| CC-122 Alone under fasted conditions | Experimental | Single oral dose of 3 mg CC-122 administered alone under fasted conditions Receives: Drug: CC-122 |
| CC-122 plus Itraconazole | Experimental | Single oral dose of 3 mg CC-122 alone and with multiple doses of itraconazole. Receives: Drug: CC-122; Drug: Itraconazole |
| CC-122 plus Fluvoxamine | Experimental | Single oral dose of 3 mg CC-122 alone and with multiple doses of fluvoxamine. Receives: Drug: CC-122; Drug: Fluvoxamine |
| CC-122 plus Rifampin | Experimental | Single oral dose of 3 mg CC-122 alone and with multiple doses of rifampin Receives: Drug: CC-122; Drug: Rifampin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic- Cmax
Observed maximum plasma concentration
Measured: up to approximately 1 month
Pharmacokinetic- AUC 0-∞
Area under the plasma concentration-time curve calculated from time zero extrapolated to infinity
Measured: up to approximately 1 month
Secondary outcomes (1)
Adverse Events (AEs)
Number of subjects with adverse event
Measured: From enrollment until at least 28 days after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start9 Nov 2017
- Primary completion27 Jan 2018
- Study completion27 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leon Carayannopoulos, MD, Study director, Celgene Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03340662
- Sponsor's protocol ID
- CC-122-CP-006
- Other IDs
- U1111-1203-1818
- Status last verified
- Jan 2019
- First submitted
- 9 Nov 2017
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, 4-Part Study to Evaluate the Effect of Food, Cytochrome P 450 Inhibition and Induction on the Pharmacokinetics of CC 122 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT03340662
- Acronym / sponsor ID
- CC-122-CP-006
- Conditions
- Healthy Volunteer
- Keywords
- Healthy Volunteer, CC-122, Adult, Phase 1, CYTOCHROME P450
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2017 (actual)
- Primary completion
- 27 Jan 2018 (actual)
- Study completion
- 27 Jan 2018 (actual)
- First posted
- 13 Nov 2017 (actual)
- 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.
This is a phase 1 open-label 4-part study to evaluate the effect of food, cytochrome P450 inhibition and induction on the pharmacokinetics of CC 122 in healthy adult subjects. Approximately 81 subjects will be enrolled. There will be approximately 24 subjects in Part 1 and approximately 19 subjects in Parts 2, 3, and 4, respectively. Subjects may participate in 1 part only.
Detailed description
This study will consist of 4 parts. Each part has two periods. The parts may be conducted in any order. Subjects may participate in 1 part only.
Each subject will participate in a screening phase, a baseline phase in each study period, a treatment phase in each study period and a follow-up telephone call. Subjects will be screened for eligibility. Eligible subjects will return to the study center on Day -1 of Period 1 and will remain at the study center until the last day of Period 2.
Part 1: On Day 1 of Period 1, eligible subjects will be randomized to 1 of 2 sequences. On Day 1 of each study period, each subject will receive 1 of 2 treatments according to the sequence in which he or she is randomized.
In Part 2, subjects will receive a single dose of CC-122 in Period 1 and, following an appropriate washout, multiple doses of itraconazole plus one dose of itraconazole with CC-122 in Period 2.
In Part 3, subjects will receive a single dose of CC-122 in Period 1 and, following an appropriate washout, multiple doses of fluvoxamine plus one dose of fluvoxamine with CC-122 in Period 2.
In Part 4, subjects will receive a single dose of CC-122 in Period 1 and, following an appropriate washout, multiple doses of rifampin plus one dose of rifampin with CC-122 in Period 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CC-122 Alone under fasted conditions | Experimental | Drug: CC-122Single oral dose of 3 mg CC-122 administered alone under fasted conditions |
| CC-122 plus Itraconazole | Experimental | Drug: CC-122, Drug: ItraconazoleSingle oral dose of 3 mg CC-122 alone and with multiple doses of itraconazole. |
| CC-122 plus Fluvoxamine | Experimental | Drug: CC-122, Drug: FluvoxamineSingle oral dose of 3 mg CC-122 alone and with multiple doses of fluvoxamine. |
| CC-122 plus Rifampin | Experimental | Drug: CC-122, Drug: RifampinSingle oral dose of 3 mg CC-122 alone and with multiple doses of rifampin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Subject must understand and voluntarily sign an Informed Consent Form (ICF) prior to any study-related assessments/procedures being conducted.
- Subject is ≥ 18 and ≤ 55 years of age at the time of signing the ICF.
- Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
- Subject is in good health as determined by a physical exam at screening.
- Subject agrees to abide by the requirements and restrictions outlined in the CC-122 Pregnancy Prevention Plan for Subjects in Clinical Trials.
Key exclusion criteria (19 listed)
- Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
- Subject has any condition that confounds the ability to interpret data from the study.
- Subject has any hypersensitivity, allergy, or other contraindication to the components of the CC-122, itraconazole, fluvoxamine, or rifampin formulations used in this study (see IB and product labels for relevant information).
- Subject is a female of childbearing potential, pregnant, or breastfeeding.
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 | CC-122 Alone under fasted conditions, CC-122 plus Fluvoxamine, CC-122 plus Itraconazole, CC-122 plus Rifampin |
| ItraconazoleCYP3A Inhibitor | Drug | CC-122 plus Itraconazole |
| FluvoxamineCYP1A2 Inhibitor | Drug | CC-122 plus Fluvoxamine |
| RifampinCYP3A Inducer | Drug | CC-122 plus Rifampin |
Primary outcome
Pharmacokinetic- Cmax
Time frame: up to approximately 1 month
Observed maximum plasma concentration
Pharmacokinetic- AUC 0-∞
Time frame: up to approximately 1 month
Area under the plasma concentration-time curve calculated from time zero extrapolated to infinity
1 secondary outcome
Adverse Events (AEs)
Time frame: From enrollment until at least 28 days after completion of treatment
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 16 Jan 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.
Leon Carayannopoulos, MD 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-122, Itraconazole and Fluvoxamine in people with Healthy Volunteer, 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 17 inclusion and 19 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 16 Jan 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?
Pharmacokinetic- Cmax (time frame: up to approximately 1 month). The study lists 2 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 16 Jan 2019.