Healthy VolunteersPhase 1NCT02110420
First-in-human Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of CC-90001
A Phase 1 study testing CC-90001 in people with Healthy Volunteers, run by Celgene Corporation at 1 site in United States.
Trial summary
First-in-human study to evaluate safety, tolerability, and pharmacokinetics of single and multiple ascending doses of CC-90001 Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- CC-90001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Sep 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Must understand and voluntarily sign a written informed consent prior to any study-related procedures being performed.
- 2. Must be able to communicate with the investigator, understand and comply with the requirements of the study, and agree to adhere to restrictions and examination schedules.
- 3. Healthy male or female of any race between 18 to 50 years of age (inclusive) at the time of signing the informed consent, and in good health as determined by a physical examination at screening.
- 4. For males: Agree to use barrier contraception not made of natural (animal) membrane [for example, latex or polyurethane condoms are acceptable]) when engaging in sexual activity with a female of childbearing potential while on study medication, and for at least 28 days after the last dose of study medication.
- For females: Female subjects must have been surgically sterilized (hysterectomy or bilateral oophorectomy; proper documentation required) at least 6 months before screening, or be postmenopausal (defined as 24 months without menses before screening, with an estradiol level of < 30 pg/mL and follicle-stimulating hormone level of > 40 IU/L at screening).
- 5. Must have a body mass index between 18 and 33 kg/m2 (inclusive). 6. Platelet count, absolute neutrophil count and absolute lymphocyte count must be above the lower limit of normal at the screening visit.
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- 7. Liver function tests must be below the upper limit of normal at screening. 8. All other clinical laboratory tests must be within normal limits or acceptable to the investigator.
- 9. Subject must be afebrile, with supine systolic blood pressure: 90 to 140 mmHg, supine diastolic blood pressure: 50 to 90 mmHg, and pulse rate: 40 to 110 bpm at screening.
- 10. Must have a normal or clinically-acceptable 12-lead electrocardiogram at screening. Male subjects must have a QTcF value ≤ 430 msec. Female subjects must have a QTcF value ≤ 450 msec.
Who cannot join
- 1. History of any clinically significant and relevant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, or other major disorders.
- 2. Any condition which places the subject at unacceptable risk if he or she were to participate in the study, or confounds the ability to interpret data from the study.
- 3. 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).
- 4. Used any prescribed systemic or topical medication (including but not limited to analgesics, anesthetics, etc) within 30 days of the first dose administration.
- 5. Used any non-prescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines) within 14 days of the first dose administration.
- 6. Used cytochrome P450 (CYP)3A inducers and inhibitors (including St. John's Wort) within 30 days of the first dose administration.
Show all 20Show fewer
- 7. Has any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism and excretion, for example, bariatric procedure. Appendectomy and cholecystectomy are acceptable.
- 8. Donated blood or plasma within 8 weeks before the first dose administration to a blood bank or blood donation center.
- 9. History of drug abuse (as defined by the current version of the Diagnostic and Statistical Manual) within 2 years before dosing, or positive drug screening test reflecting consumption of illicit drugs.
- 10. History of alcohol abuse (as defined by the current version of the Diagnostic and Statistical Manual) within 2 years before dosing, or positive alcohol screen.
- 11. Known to have serum hepatitis or known to be a carrier of hepatitis B surface antigen or hepatitis c antibody, or have a positive result to the test for human immunodeficiency virus antibodies at screening.
- 12. Smoke more than 10 cigarettes per day, or the equivalent in other tobacco products (self reported).
- 13. History of ulcerative colitis, Crohn's disease, diverticular disease, any polyp(s) along the gastrointestinal tract, or colorectal cancer.
- 14. History of hemorrhoids, anal fissures, rectal ulcers, minor rectal bleeding (such as red blood on toilet paper after wiping) within 5 years before the first dose administration.
- 15. History of gastrointestinal bleeding or blood in stool within 5 years before the first dose administration.
- 16. Any positive fecal occult blood test at screening and/or at any time prior to first dosing.
- 17. Any history of constipation within 2 years before the first dose administration.
- 18. Subject does not routinely have a bowel movement, at minimum, every third day.
- 19. Any subject with a history of Irritable Bowel Syndrome or a history of frequent abdominal cramping, frequent diarrhea, or frequent loose stools (with frequent defined as once per week or greater).
- 20. Any female subject with menses (natural or artificial). 21. Any subject taking hormonal contraception. 22. Subjects who are part of the clinical staff personnel or family members of the clinical site staff.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Two-part Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of CC-90001 in Healthy Subjects
First-in-human study to evaluate safety, tolerability, and pharmacokinetics of single and multiple ascending doses of CC-90001
Read the detailed description
This is a 2-part study to be conducted at a single study center. Part 1 is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of CC-90001 following a single oral dose in healthy subjects. During the course of Part 1, each subject will participate in a screening phase, a baseline phase, a treatment phase and a follow up visit. There will be a total of 7 planned cohorts, each of which will consist of a different dose level, with 8 subjects per cohort. In each cohort, 6 subjects will receive a dose of CC 90001 and 2 subjects will receive placebo depending on the randomization schedule. Administration of study drug at the next higher dose level will not begin until the safety and tolerability of the preceding dose have been evaluated and deemed acceptable by the investigator and sponsor's medical monitor. Part 2 is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of CC-90001 following multiple oral doses in healthy subjects. Only doses that are safe and well tolerated in Part 1 will be administered in Part 2. During the course of Part 2, each subject will participate in a screening phase, a baseline phase, a treatment phase and a follow up visit. There will be a total of up to 6 planned cohorts, each of which will consist of a different dose level, with 8 subjects per cohort. In each cohort, 6 subjects will receive a dose of CC 90001 and 2 subjects will receive placebo depending on the randomization schedule. It is planned for study drug to be administered once daily for up to 14 days. Proposed dose levels in Part 2 may be modified and/or eliminated based on data obtained from Part 1; however, the maximum dose administered in Part 2 will not exceed the maximum tolerated dose in Part 1.
- Conditions
- Healthy Volunteers
- Being tested
- CC-90001, Placebo
- Keywords
- Safety, Pharmacokinetics, Healthy Subjects, First-in-Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-90001Drug
CC-90001 10mg will be administered as a single dose
CC-90001Drug
CC-90001 30mg will be administered as a single dose
CC-90001Drug
CC-90001 60mg will be administered as a single dose
CC-90001Drug
CC-90001 120mg will be administered as a single dose
CC-90001Drug
CC-90001 240mg will be administered as a single dose
CC-90001Drug
CC-90001 10mg will be administered daily for 14 days
CC-90001Drug
CC-90001 30mg will be administered daily for 14 days
CC-90001Drug
CC-90001 60mg will be administered daily for 14 days
CC-90001Drug
CC-90001 120mg will be administered daily for 14 days
CC-90001Drug
CC-90001 240mg will be administered daily for 14 days
PlaceboDrug
Placebo will be administered once daily for up to 14 days depending on the Part of the study
CC-90001Drug
CC-90001 480mg will be administered as a single oral dose
CC-90001Drug
CC-90001 720mg will be administered as a single oral dose
CC-90001Drug
CC-90001 480mg will be administered daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| CC-90001 10mg (Single Dose) | Experimental | Not described Receives: Drug: CC-90001 |
| CC-90001 30mg (Single Dose) | Experimental | Not described Receives: Drug: CC-90001 |
| CC-90001 60mg (Single Dose) | Experimental | Not described Receives: Drug: CC-90001 |
| CC-90001 120mg (Single Dose) | Experimental | Not described Receives: Drug: CC-90001 |
| CC-90001 240mg (Single Dose) | Experimental | Not described Receives: Drug: CC-90001 |
| CC-90001 10mg (Multiple Doses) | Experimental | Not described Receives: Drug: CC-90001 |
| CC-90001 30mg (Multiple Doses) | Experimental | Not described Receives: Drug: CC-90001 |
| CC-90001 60mg (Multiple Doses) | Experimental | Not described Receives: Drug: CC-90001 |
| CC-90001 120mg (Multiple Doses) | Experimental | Not described Receives: Drug: CC-90001 |
| CC-90001 240mg (Multiple Doses) | Experimental | Not described Receives: Drug: CC-90001 |
| Placebo | Experimental | Not described Receives: Drug: Placebo |
| CC-90001 480mg (single dose) | Experimental | CC-90001 480mg will be administered as a single oral dose Receives: Drug: CC-90001 |
| CC-90001 720mg (single dose) | Experimental | CC-90001 720mg will be administered as a single oral dose Receives: Drug: CC-90001 |
| CC-90001 480mg (multiple doses) | Experimental | CC-90001 480mg will be administered daily for 14 days Receives: Drug: CC-90001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Number of participants with adverse events
Measured: Up to 8 months overall
Secondary outcomes (10)
Concentrations of CC-90001 in plasma
Blood samples will be collected at pre-specified times to determine levels of CC-90001 in plasma
Measured: Up to 14 days per cohort
Cmax: Maximum observed plasma concentration
Cmax will be estimated for CC-90001 using a non-compartmental approach
Measured: Up to 14 days per cohort
Tmax: Time to Cmax
Tmax will be estimated for CC-90001 using a non-compartmental approach
Measured: Up to 14 days per cohort
AUCinf: Area under the plasma concentration-time curve from time zero extrapolated to infinity
AUCinf will be estimated for CC-90001 using a non-compartmental approach
Measured: Up to 14 days per cohort
AUCt: Area under the plasma concentration-time curve from time zero to the last quantifiable concentration
AUCt will be estimated for CC-90001 using a non-compartmental approach
Measured: Up to 14 days per cohort
AUCtau: Area under the plasma concentration-time curve from time zero to tau, where tau is the dosing interval
AUCtau will be estimated for CC-90001 using a non-compartmental approach
Measured: Up to 14 days per cohort
AUCtau will be estimated for CC-90001 using a non-compartmental approach
t1/2,z will be estimated for CC-90001 using a non-compartmental approach
Measured: Up to 14 days per cohort
CL/F: Apparent total plasma clearance when dosed orally
CL/F will be estimated for CC-90001 using a non-compartmental approach
Measured: Up to 14 days per cohort
Vz/F: Apparent total volume of distribution when dosed orally, based on the terminal phase
Vz/F will be estimated for CC-90001 using a non-compartmental approach
Measured: Up to 14 days per cohort
Ratio of Accumulation based on Day 1 and Day 14 AUCtau
Ratio of accumulation will be estimated for CC-90001 using a non-compartmental approach
Measured: Up to 14 days per cohort
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startFeb 2014
- Primary completionSep 2014
- Study completionSep 2014
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.
- 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Weiss, MD, Study director, Celgene Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02110420
- Sponsor's protocol ID
- CC-90001-CP-001
- Status last verified
- Oct 2014
- First submitted
- 12 Feb 2014
- Last updated
- 15 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Two-part Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of CC-90001 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02110420
- Acronym / sponsor ID
- CC-90001-CP-001
- Conditions
- Healthy Volunteers
- Keywords
- Safety, Pharmacokinetics, Healthy Subjects, First-in-Human
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Celgene CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 10 Apr 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.
First-in-human study to evaluate safety, tolerability, and pharmacokinetics of single and multiple ascending doses of CC-90001
Detailed description
This is a 2-part study to be conducted at a single study center. Part 1 is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of CC-90001 following a single oral dose in healthy subjects. During the course of Part 1, each subject will participate in a screening phase, a baseline phase, a treatment phase and a follow up visit. There will be a total of 7 planned cohorts, each of which will consist of a different dose level, with 8 subjects per cohort. In each cohort, 6 subjects will receive a dose of CC 90001 and 2 subjects will receive placebo depending on the randomization schedule. Administration of study drug at the next higher dose level will not begin until the safety and tolerability of the preceding dose have been evaluated and deemed acceptable by the investigator and sponsor's medical monitor. Part 2 is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of CC-90001 following multiple oral doses in healthy subjects. Only doses that are safe and well tolerated in Part 1 will be administered in Part 2. During the course of Part 2, each subject will participate in a screening phase, a baseline phase, a treatment phase and a follow up visit. There will be a total of up to 6 planned cohorts, each of which will consist of a different dose level, with 8 subjects per cohort. In each cohort, 6 subjects will receive a dose of CC 90001 and 2 subjects will receive placebo depending on the randomization schedule. It is planned for study drug to be administered once daily for up to 14 days. Proposed dose levels in Part 2 may be modified and/or eliminated based on data obtained from Part 1; however, the maximum dose administered in Part 2 will not exceed the maximum tolerated dose in Part 1.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| CC-90001 10mg (Single Dose) | Experimental | Drug: CC-90001 |
| CC-90001 30mg (Single Dose) | Experimental | Drug: CC-90001 |
| CC-90001 60mg (Single Dose) | Experimental | Drug: CC-90001 |
| CC-90001 120mg (Single Dose) | Experimental | Drug: CC-90001 |
| CC-90001 240mg (Single Dose) | Experimental | Drug: CC-90001 |
| CC-90001 10mg (Multiple Doses) | Experimental | Drug: CC-90001 |
| CC-90001 30mg (Multiple Doses) | Experimental | Drug: CC-90001 |
| CC-90001 60mg (Multiple Doses) | Experimental | Drug: CC-90001 |
| CC-90001 120mg (Multiple Doses) | Experimental | Drug: CC-90001 |
| CC-90001 240mg (Multiple Doses) | Experimental | Drug: CC-90001 |
| Placebo | Experimental | Drug: Placebo |
| CC-90001 480mg (single dose) | Experimental | Drug: CC-90001CC-90001 480mg will be administered as a single oral dose |
| CC-90001 720mg (single dose) | Experimental | Drug: CC-90001CC-90001 720mg will be administered as a single oral dose |
| CC-90001 480mg (multiple doses) | Experimental | Drug: CC-90001CC-90001 480mg will be administered daily for 14 days |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 1. Must understand and voluntarily sign a written informed consent prior to any study-related procedures being performed.
- 2. Must be able to communicate with the investigator, understand and comply with the requirements of the study, and agree to adhere to restrictions and examination schedules.
- 3. Healthy male or female of any race between 18 to 50 years of age (inclusive) at the time of signing the informed consent, and in good health as determined by a physical examination at screening.
- 4. For males: Agree to use barrier contraception not made of natural (animal) membrane [for example, latex or polyurethane condoms are acceptable]) when engaging in sexual activity with a female of childbearing potential while on study medication, and for at least 28 days after the last dose of study medication.
- For females: Female subjects must have been surgically sterilized (hysterectomy or bilateral oophorectomy; proper documentation required) at least 6 months before screening, or be postmenopausal (defined as 24 months without menses before screening, with an estradiol level of < 30 pg/mL and follicle-stimulating hormone level of > 40 IU/L at screening).
Key exclusion criteria (20 listed)
- 1. History of any clinically significant and relevant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, or other major disorders.
- 2. Any condition which places the subject at unacceptable risk if he or she were to participate in the study, or confounds the ability to interpret data from the study.
- 3. 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).
- 4. Used any prescribed systemic or topical medication (including but not limited to analgesics, anesthetics, etc) within 30 days of the first dose administration.
- 5. Used any non-prescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines) within 14 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-90001CC-90001 10mg will be administered as a single dose | Drug | CC-90001 10mg (Single Dose) |
| CC-90001CC-90001 30mg will be administered as a single dose | Drug | CC-90001 30mg (Single Dose) |
| CC-90001CC-90001 60mg will be administered as a single dose | Drug | CC-90001 60mg (Single Dose) |
| CC-90001CC-90001 120mg will be administered as a single dose | Drug | CC-90001 120mg (Single Dose) |
| CC-90001CC-90001 240mg will be administered as a single dose | Drug | CC-90001 240mg (Single Dose) |
| CC-90001CC-90001 10mg will be administered daily for 14 days | Drug | CC-90001 10mg (Multiple Doses) |
| CC-90001CC-90001 30mg will be administered daily for 14 days | Drug | CC-90001 30mg (Multiple Doses) |
| CC-90001CC-90001 60mg will be administered daily for 14 days | Drug | CC-90001 60mg (Multiple Doses) |
| CC-90001CC-90001 120mg will be administered daily for 14 days | Drug | CC-90001 120mg (Multiple Doses) |
| CC-90001CC-90001 240mg will be administered daily for 14 days | Drug | CC-90001 240mg (Multiple Doses) |
| PlaceboPlacebo will be administered once daily for up to 14 days depending on the Part of the study | Drug | Placebo |
| CC-90001CC-90001 480mg will be administered as a single oral dose | Drug | CC-90001 480mg (single dose) |
| CC-90001CC-90001 720mg will be administered as a single oral dose | Drug | CC-90001 720mg (single dose) |
| CC-90001CC-90001 480mg will be administered daily for 14 days | Drug | CC-90001 480mg (multiple doses) |
Primary outcome
Adverse Events
Time frame: Up to 8 months overall
Number of participants with adverse events
10 secondary outcomes
Concentrations of CC-90001 in plasma
Time frame: Up to 14 days per cohort
Cmax: Maximum observed plasma concentration
Time frame: Up to 14 days per cohort
Tmax: Time to Cmax
Time frame: Up to 14 days per cohort
AUCinf: Area under the plasma concentration-time curve from time zero extrapolated to infinity
Time frame: Up to 14 days per cohort
AUCt: Area under the plasma concentration-time curve from time zero to the last quantifiable concentration
Time frame: Up to 14 days per cohort
AUCtau: Area under the plasma concentration-time curve from time zero to tau, where tau is the dosing interval
Time frame: Up to 14 days per cohort
AUCtau will be estimated for CC-90001 using a non-compartmental approach
Time frame: Up to 14 days per cohort
CL/F: Apparent total plasma clearance when dosed orally
Time frame: Up to 14 days per cohort
Vz/F: Apparent total volume of distribution when dosed orally, based on the terminal phase
Time frame: Up to 14 days per cohort
Ratio of Accumulation based on Day 1 and Day 14 AUCtau
Time frame: Up to 14 days per cohort
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 15 Oct 2014.
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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.
Daniel Weiss, 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-90001 in people with Healthy Volunteers, 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 9 inclusion and 20 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 15 Oct 2014. 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?
Adverse Events (time frame: Up to 8 months overall). 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 15 Oct 2014.