Healthy VolunteersPhase 1NCT03135509
A Study to Assess the Relative Bioavailability of a New CC-220 Capsule Formulation, Compared to a Reference CC-220 Capsule Formulation, in Healthy Adult Subjects
A Phase 1 study testing CC-220 in people with Healthy Volunteers, run by Celgene at 1 site in United States.
Trial summary
This is an open-label, randomized, 2-period, 2-way crossover study to assess the relative bioavailability of a new CC-220 capsule formulation, compared to a reference CC-220 capsule formulation, after administration of single oral doses in healthy adult subjects under fasted conditions. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- CC-220
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2017to 28 Jun 2017
- 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 the Investigator based on 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, 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)2 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.
- 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 the Investigator based on 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.
- 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, 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)2 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 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 5 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 14 days or 5 half-lives of that medication, 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 7 days prior to the first dose administration.
- Subject has used Cytochrome P450 (CYP)3A inducers and/or inhibitors (including St. John's wort) within 30 days prior to the first dose administration..
- 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 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 test.
- 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.
United States1 site
Quintiles Phase One Services, LLC
Overland Park, Kansas, 66211
About this study
Official title: A Phase 1, Open-label, Single-center Study to Assess the Relative Bioavailability of a New CC-220 Capsule Formulation, Compared to a Reference CC-220 Capsule Formulation, in Healthy Adult Subjects
This is an open-label, randomized, 2-period, 2-way crossover study to assess the relative bioavailability of a new CC-220 capsule formulation, compared to a reference CC-220 capsule formulation, after administration of single oral doses in healthy adult subjects under fasted conditions.
Approximately 16 subjects will be assigned randomly to 1 of 2 treatment sequences. The sequences will dictate the order in which each subject receives the following treatments:
- Treatment A (Reference): A single dose of 0.6 mg CC-220, administered as two 0.3-mg formulated CC-220 gelatin capsules.
- Treatment B (Test): A single dose of 0.6 mg CC-220, administered as one 0.6-mg formulated CC-220 Hydroxypropyl methylcellulose (HPMC) capsule.
Read the detailed description
The study will consist of 2 study periods. 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 domiciled at the study center from Day -1 of Period 1 to Day 4 of Period 2.
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.
Blood samples will be collected at prespecified times for PK, PD, and clinical laboratory safety tests. Urine samples will be collected at prespecified times for clinical laboratory safety tests.
Safety will be monitored throughout the study. Safety evaluations will include AE reporting, review of concomitant medications and procedures, physical examinations (PEs), 12-lead ECGs, vital sign measurements, and clinical laboratory safety tests. Subjects will be discharged from the study center on Day 4 of Period 2 upon completion of scheduled study-related procedures and satisfactory safety review. Each subject will receive a follow-up telephone call within 5 to 7 days following discharge from the study center.
The study will be conducted in compliance with the International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.
- Conditions
- Healthy Volunteers
- Being tested
- CC-220
- Keywords
- Healthy Subjects, CC-220 Capsules, Relative Bioavailability, Phase 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-220Drug
CC-220 gelatin capsules
| Study group | Role | What they receive |
|---|---|---|
| Treatment A (Reference)- CC-220 gelatin capsules | Experimental | A single dose of 0.6 mg CC-220, administered as two 0.3-mg formulated CC-220 gelatin capsules. Receives: Drug: CC-220 |
| Treatment B (Test)- CC-220 HPMC capsule | Experimental | A single dose of 0.6 mg CC-220, administered as one 0.6-mg formulated CC-220 hydroxypropyl methylcellulose (HPMC) capsule. Receives: Drug: CC-220 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK - Cmax
Observed maximum plasma concentration
Measured: Up to approximately 1 month
PK - AUC0-t
Area under the concentration-time curve calculated from time zero to the last measured time point
Measured: Up to approximately 1 month
Secondary outcomes (1)
Adverse Events (AEs)
Number of participants with adverse event
Measured: Up to approximately 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start24 May 2017
- Primary completion28 Jun 2017
- Study completion28 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria Palmisano, MD, Study director, Celgene Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03135509
- Sponsor's protocol ID
- CC-220-CP-005
- Other IDs
- U1111-1195-6929
- Status last verified
- Jun 2017
- First submitted
- 27 Apr 2017
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Single-center Study to Assess the Relative Bioavailability of a New CC-220 Capsule Formulation, Compared to a Reference CC-220 Capsule Formulation, in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT03135509
- Acronym / sponsor ID
- CC-220-CP-005
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Subjects, CC-220 Capsules, Relative Bioavailability, Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 24 May 2017 (actual)
- Primary completion
- 28 Jun 2017 (actual)
- Study completion
- 28 Jun 2017 (actual)
- First posted
- 1 May 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 an open-label, randomized, 2-period, 2-way crossover study to assess the relative bioavailability of a new CC-220 capsule formulation, compared to a reference CC-220 capsule formulation, after administration of single oral doses in healthy adult subjects under fasted conditions.
Approximately 16 subjects will be assigned randomly to 1 of 2 treatment sequences. The sequences will dictate the order in which each subject receives the following treatments:
- Treatment A (Reference): A single dose of 0.6 mg CC-220, administered as two 0.3-mg formulated CC-220 gelatin capsules.
- Treatment B (Test): A single dose of 0.6 mg CC-220, administered as one 0.6-mg formulated CC-220 Hydroxypropyl methylcellulose (HPMC) capsule.
Detailed description
The study will consist of 2 study periods. 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 domiciled at the study center from Day -1 of Period 1 to Day 4 of Period 2.
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.
Blood samples will be collected at prespecified times for PK, PD, and clinical laboratory safety tests. Urine samples will be collected at prespecified times for clinical laboratory safety tests.
Safety will be monitored throughout the study. Safety evaluations will include AE reporting, review of concomitant medications and procedures, physical examinations (PEs), 12-lead ECGs, vital sign measurements, and clinical laboratory safety tests. Subjects will be discharged from the study center on Day 4 of Period 2 upon completion of scheduled study-related procedures and satisfactory safety review. Each subject will receive a follow-up telephone call within 5 to 7 days following discharge from the study center.
The study will be conducted in compliance with the International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A (Reference)- CC-220 gelatin capsules | Experimental | Drug: CC-220A single dose of 0.6 mg CC-220, administered as two 0.3-mg formulated CC-220 gelatin capsules. |
| Treatment B (Test)- CC-220 HPMC capsule | Experimental | Drug: CC-220A single dose of 0.6 mg CC-220, administered as one 0.6-mg formulated CC-220 hydroxypropyl methylcellulose (HPMC) capsule. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 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 the Investigator based on 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 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 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 5 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-220CC-220 gelatin capsules | Drug | Treatment A (Reference)- CC-220 gelatin capsules, Treatment B (Test)- CC-220 HPMC capsule |
Primary outcome
PK - Cmax
Time frame: Up to approximately 1 month
Observed maximum plasma concentration
PK - AUC0-t
Time frame: Up to approximately 1 month
Area under the concentration-time curve calculated from time zero to the last measured time point
1 secondary outcome
Adverse Events (AEs)
Time frame: Up to approximately 1 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 2 Jul 2017.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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 in people with Healthy Volunteers, 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 32 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 2 Jul 2017. 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?
PK - 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 2 Jul 2017.