PharmacokineticsPhase 1NCT02820935
Study to Evaluate the Effect of Cytochrome P450 (CYP) 3A Inhibition and Induction on the Pharmacokinetics of CC-220 in Healthy Subjects
A Phase 1 study testing CC-220, Rifampin and Itraconazole in people with Pharmacokinetics, run by Celgene Corporation at 1 site in United States.
Trial summary
This is a two-part study to be conducted at a single study site in the US. Both parts of the study may be conducted in parallel. A total of approximately 38 subjects will participate in this study, with approximately 19 subjects in Part 1 and approximately 19 subjects in Part 2. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- CC-220, Rifampin and Itraconazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Sep 2016
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must satisfy the following criteria to be enrolled in the study:
- Subject is ≥ 18 and ≤ 65 years of age at the time of signing the informed consent form (ICF).
- Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
- 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 examination (PE) at screening.
- Subject agrees to abide by the requirements and restrictions outlined in the CC-220 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 abstinence1 (which must be reviewed on a monthly basis 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)2 while participating in the study, during dose interruptions, and for at least 28 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.
- 1 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). 2 A female of childbearing potential (FCBP) is a female who: 1) has achieved menarche at some point; 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months).
- 9. Subject has clinical laboratory safety test results that are within normal limits or acceptable to the Investigator. Platelet count, absolute neutrophil count, and absolute lymphocyte count must be above the lower limit of normal at screening.
- 10. 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.
- 11. Subject has a normal or clinically acceptable 12-lead ECG (Electrocardiogram) at screening. In addition:
- If male, subject has a corrected QT value (based on Fridericia's formula) ≤ 430 msec at screening.
- If female, subject has a corrected QT value (based on Fridericia's formula) ≤ 450 msec at screening.
Who cannot join
- The presence of any of the following will exclude a subject from enrollment:
- Subject has any significant and relevant medical condition (including but not limited to neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, or other major disorders), 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 is a female of childbearing potential, pregnant, or breastfeeding.
- 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).
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- Subject has used any prescribed systemic or topical medication (including but not limited to analgesics, anesthetics, etc) within 30 days 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 inducers and/or inhibitors (including St. John's wort) within 30 days prior to the first dose administration. The Indiana University "Cytochrome P450 Drug Interaction Table" should be utilized to determine inhibitors and/or inducers of CYP3A.
- Subject has any surgical or medical conditions 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 Diagnostic and Statistical Manual (DSM)) within 2 years before the first dose administration, or positive alcohol screen.
- 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 is part of the clinical staff personnel or a family member of the clinical site staff.
- 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 Investigational Product (IP).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Single-center Study to Evaluate the Effect of Cytochrome P450 (CYP) 3A Inhibition and Induction on the Pharmacokinetics of CC-220 in Healthy Subjects
This is a two-part study to be conducted at a single study site in the US. Both parts of the study may be conducted in parallel.
A total of approximately 38 subjects will participate in this study, with approximately 19 subjects in Part 1 and approximately 19 subjects in Part 2. Each subject may only participate in one of the parts.
Read the detailed description
This is a two part study to be conducted at a single study site. Both parts of the study may be conducted in parallel.
A total of approximately 38 subjects will participate in this study, with approximately 19 subjects in Part 1 and approximately 19 subjects in Part 2. Each subject may only participate in one of the parts.
Each Part will consist of 2 study periods. Part 1 and Part 2, each subject will participate in a Screening phase, one baseline visit per period, one dosing phase per period, and follow-up telephone call.
In Part 1, subjects will receive a single dose of CC-220 in Period 1 and, following an appropriate washout, multiple doses of itraconazole plus one dose of itraconazole with CC-220 in Period 2. In Part 2, subjects will receive CC-220 in Period 1 and, following an appropriate washout, multiple doses of rifampin plus one dose of rifampin with CC-220 in Period 2.
- Conditions
- Pharmacokinetics
- Being tested
- CC-220, Rifampin, Itraconazole
- Keywords
- Cytochrome P450, Pharmacokinetics, CC-220, Healthy Subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-220Drug
RifampinDrug
ItraconazoleDrug
| Study group | Role | What they receive |
|---|---|---|
| Part 1, Period 1: CC-220 | Experimental | Single dose of 0.6mg CC-220 Receives: Drug: CC-220 |
| Part 1, Period 2: itraconazole with CC-220 | Experimental | Multiple does of 200 mg itraconazole alone, with a single dose of 0.6 mg CC-220 plus itraconazole Receives: Drug: CC-220; Drug: Itraconazole |
| Part 2, Period 1: CC-220 | Experimental | Single dose of 0.6mg CC-220 Receives: Drug: CC-220 |
| Part 2, Period 2: rifampin with CC-220 | Experimental | Multiple doses of 600 mg rifampin alone, with a single dose of 0.6 mg CC-220 plus rifampin Receives: Drug: CC-220; Drug: Rifampin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics- Cmax
Maximum plasma concentration
Measured: Up to 96 hours
Pharmacokinetics- AUC∞
Area under the plasma concentration from time zero extrapolated to infinity
Measured: Up to 96 hours
Secondary outcomes (1)
Adverse Events (AEs)
Number of participants with adverse events
Measured: Up to approximately 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria Palmisano, MD, Study director, Celgene Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02820935
- Sponsor's protocol ID
- CC-220-CP-003
- Status last verified
- Oct 2016
- First submitted
- 29 Jun 2016
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Gaudy A, Atsriku C, Ye Y, MacGorman K, Liu L, Xue Y, Surapaneni S, Palmisano M. Evaluation of iberdomide and cytochrome p450 drug-drug interaction potential in vitro and in a phase 1 study in healthy subjects. Eur J Clin Pharmacol. 2021 Feb;77(2):223-231. doi: 10.1007/s00228-020-03004-w. Epub 2020 Sep 23.
PubMed 32965548
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Single-center Study to Evaluate the Effect of Cytochrome P450 (CYP) 3A Inhibition and Induction on the Pharmacokinetics of CC-220 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02820935
- Acronym / sponsor ID
- CC-220-CP-003
- Conditions
- Pharmacokinetics
- Keywords
- Cytochrome P450, Pharmacokinetics, CC-220, Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Celgene CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 1 Jul 2016 (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.
This is a two-part study to be conducted at a single study site in the US. Both parts of the study may be conducted in parallel.
A total of approximately 38 subjects will participate in this study, with approximately 19 subjects in Part 1 and approximately 19 subjects in Part 2. Each subject may only participate in one of the parts.
Detailed description
This is a two part study to be conducted at a single study site. Both parts of the study may be conducted in parallel.
A total of approximately 38 subjects will participate in this study, with approximately 19 subjects in Part 1 and approximately 19 subjects in Part 2. Each subject may only participate in one of the parts.
Each Part will consist of 2 study periods. Part 1 and Part 2, each subject will participate in a Screening phase, one baseline visit per period, one dosing phase per period, and follow-up telephone call.
In Part 1, subjects will receive a single dose of CC-220 in Period 1 and, following an appropriate washout, multiple doses of itraconazole plus one dose of itraconazole with CC-220 in Period 2. In Part 2, subjects will receive CC-220 in Period 1 and, following an appropriate washout, multiple doses of rifampin plus one dose of rifampin with CC-220 in Period 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1, Period 1: CC-220 | Experimental | Drug: CC-220Single dose of 0.6mg CC-220 |
| Part 1, Period 2: itraconazole with CC-220 | Experimental | Drug: CC-220, Drug: ItraconazoleMultiple does of 200 mg itraconazole alone, with a single dose of 0.6 mg CC-220 plus itraconazole |
| Part 2, Period 1: CC-220 | Experimental | Drug: CC-220Single dose of 0.6mg CC-220 |
| Part 2, Period 2: rifampin with CC-220 | Experimental | Drug: CC-220, Drug: RifampinMultiple doses of 600 mg rifampin alone, with a single dose of 0.6 mg CC-220 plus rifampin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Subject is ≥ 18 and ≤ 65 years of age at the time of signing the informed consent form (ICF).
- Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
- 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 examination (PE) at screening.
- Subject agrees to abide by the requirements and restrictions outlined in the CC-220 Pregnancy Prevention Plan for Subjects in Clinical Trials.
Key exclusion criteria (17 listed)
- Subject has any significant and relevant medical condition (including but not limited to neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, or other major disorders), 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 is a female of childbearing potential, pregnant, or breastfeeding.
- 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).
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-220 | Drug | Part 1, Period 1: CC-220, Part 1, Period 2: itraconazole with CC-220, Part 2, Period 1: CC-220, Part 2, Period 2: rifampin with CC-220 |
| Rifampin | Drug | Part 2, Period 2: rifampin with CC-220 |
| Itraconazole | Drug | Part 1, Period 2: itraconazole with CC-220 |
Primary outcome
Pharmacokinetics- Cmax
Time frame: Up to 96 hours
Maximum plasma concentration
Pharmacokinetics- AUC∞
Time frame: Up to 96 hours
Area under the plasma concentration from time zero extrapolated to infinity
1 secondary outcome
Adverse Events (AEs)
Time frame: Up to approximately 2 month
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 18 Oct 2016.
- Derived from this study: PubMed 32965548Gaudy A, Atsriku C, Ye Y, MacGorman K, Liu L, Xue Y, Surapaneni S, Palmisano M. Evaluation of iberdomide and cytochrome p450 drug-drug interaction potential in vitro and in a phase 1 study in healthy subjects. Eur J Clin Pharmacol. 2021 Feb;77(2):223-231. doi: 10.1007/s00228-020-03004-w. Epub 2020 Sep 23.
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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, 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-220, Rifampin and Itraconazole in people with Pharmacokinetics, run by Celgene Corporation 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 17 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 18 Oct 2016. 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- Cmax (time frame: Up to 96 hours). 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?
On the ClinicalTrials.gov record for NCT02820935, which also lists 1 linked publication.
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 18 Oct 2016.