Healthy VolunteerPhase 1NCT03958864
A Study of Safety, Tolerability, and Pharmacokinetics of Multiple-Dose CC-90001 in Japanese and Caucasian Healthy Subjects
A Phase 1 study testing CC-90001 in people with Healthy Volunteer, run by Celgene at 1 site in United States.
Trial summary
This is a Phase 1, open-label, randomized, parallel design study to evaluate the PK and safety/tolerability of CC 90001 in Japanese and Caucasian healthy adult subjects. The study will consist of multiple oral doses of IP (QD x 7 days) in 3 planned dose level cohorts of 100 mg, 200 mg, and 400 mg. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- CC-90001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2019to 13 Jun 2019
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must satisfy all of the following criteria to be enrolled in the study:
- Healthy, adult, male and female subjects.
- Japanese subjects who were born in Japan and not have lived outside of Japan for more than 10 years, have both parents and grandparents of Japanese origin, and have not significantly modified their diets since leaving Japan.
- Caucasian subjects who have age and body mass index matched with Japanese subjects.
Who cannot join
- Has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study or place the subject at unacceptable risk if he/she were to participate in the study.
- Use of any prescribed systemic or topical medication within 30 days of the first dose administration.
- Has any surgical or medical condition(s) possibly affecting drug absorption, distribution, metabolism, and excretion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A PHASE 1, OPEN LABEL STUDY TO EVALUATE THE PHARMACOKINETICS AND SAFETY/TOLERABILITY OF CC-90001 IN JAPANESE HEALTHY SUBJECTS
This is a Phase 1, open-label, randomized, parallel design study to evaluate the PK and safety/tolerability of CC 90001 in Japanese and Caucasian healthy adult subjects.
The study will consist of multiple oral doses of IP (QD x 7 days) in 3 planned dose level cohorts of 100 mg, 200 mg, and 400 mg. Each cohort will have 20 subjects (10 Japanese subjects and 10 Caucasian subjects, with a minimum of 8 subjects to complete in each group) who will receive IP (see below).
- Conditions
- Healthy Volunteer
- Being tested
- CC-90001
- Keywords
- Healthy Subjects, CC-90001, Japanese, Caucasian, Safety, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-90001Drug
CC-90001
| Study group | Role | What they receive |
|---|---|---|
| CC-90001 100 mg | Experimental | 100 mg of CC-90001 (once daily [QD] x 7 days) will be given orally Receives: Drug: CC-90001 |
| CC-90001 200 mg | Experimental | 200 mg of CC-90001 (once daily [QD] x 7 days) will be given orally Receives: Drug: CC-90001 |
| CC-90001 400 mg | Experimental | 400 mg of CC-90001 (once daily [QD] x 7 days) will be given orally Receives: Drug: CC-90001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic- AUC0-t
Area under the plasma concentration-time curve from time zero to the time point of the last measurable concentration
Measured: Day 1 and Day 7- 10
Pharmacokinetic- AUC0-∞
Area under the plasma concentration-time curve from time zero to infinity
Measured: Day 1 and Day 7- 10
Pharmacokinetic- CL/F
Estimation of apparent clearance of drug from plasma after extravascular administration
Measured: Day 1 and Day 7- 10
Pharmacokinetic- Vz/F
Estimation of apparent volume of distribution during the terminal phase
Measured: Day 1 and Day 7- 10
Pharmacokinetic- Cmax
Estimation of observed maximum plasma concentration
Measured: Day 1 and Day 7
Pharmacokinetic- Tmax
Estimation of time to Cmax
Measured: Day 1 and Day 7
Pharmacokinetic- t1/2
Description: Estimation of terminal elimination half-life
Measured: Day 1 and Day 7- 10
Secondary outcomes (1)
Adverse Events (AEs)
Number participants with Adverse Event
Measured: From enrollment until at least 28 days after completion of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start4 Apr 2019
- Primary completion13 Jun 2019
- Study completion13 Jun 2019
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ying Ye, PhD, Study director, Celgene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03958864
- Sponsor's protocol ID
- CC-90001-CP-006
- Other IDs
- U1111-1229-5813
- Status last verified
- May 2020
- First submitted
- 20 May 2019
- Last updated
- 8 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, OPEN LABEL STUDY TO EVALUATE THE PHARMACOKINETICS AND SAFETY/TOLERABILITY OF CC-90001 IN JAPANESE HEALTHY SUBJECTS
- ClinicalTrials.gov ID
- NCT03958864
- Acronym / sponsor ID
- CC-90001-CP-006
- Conditions
- Healthy Volunteer
- Keywords
- Healthy Subjects, CC-90001, Japanese, Caucasian, Safety, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 4 Apr 2019 (actual)
- Primary completion
- 13 Jun 2019 (actual)
- Study completion
- 13 Jun 2019 (actual)
- First posted
- 22 May 2019 (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, randomized, parallel design study to evaluate the PK and safety/tolerability of CC 90001 in Japanese and Caucasian healthy adult subjects.
The study will consist of multiple oral doses of IP (QD x 7 days) in 3 planned dose level cohorts of 100 mg, 200 mg, and 400 mg. Each cohort will have 20 subjects (10 Japanese subjects and 10 Caucasian subjects, with a minimum of 8 subjects to complete in each group) who will receive IP (see below).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CC-90001 100 mg | Experimental | Drug: CC-90001100 mg of CC-90001 (once daily [QD] x 7 days) will be given orally |
| CC-90001 200 mg | Experimental | Drug: CC-90001200 mg of CC-90001 (once daily [QD] x 7 days) will be given orally |
| CC-90001 400 mg | Experimental | Drug: CC-90001400 mg of CC-90001 (once daily [QD] x 7 days) will be given orally |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy, adult, male and female subjects.
- Japanese subjects who were born in Japan and not have lived outside of Japan for more than 10 years, have both parents and grandparents of Japanese origin, and have not significantly modified their diets since leaving Japan.
- Caucasian subjects who have age and body mass index matched with Japanese subjects.
Key exclusion criteria (3 listed)
- Has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study or place the subject at unacceptable risk if he/she were to participate in the study.
- Use of any prescribed systemic or topical medication within 30 days of the first dose administration.
- Has any surgical or medical condition(s) possibly affecting drug absorption, distribution, metabolism, and excretion.
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 | Drug | CC-90001 100 mg, CC-90001 200 mg, CC-90001 400 mg |
Primary outcome
Pharmacokinetic- AUC0-t
Time frame: Day 1 and Day 7- 10
Area under the plasma concentration-time curve from time zero to the time point of the last measurable concentration
Pharmacokinetic- AUC0-∞
Time frame: Day 1 and Day 7- 10
Area under the plasma concentration-time curve from time zero to infinity
Pharmacokinetic- CL/F
Time frame: Day 1 and Day 7- 10
Estimation of apparent clearance of drug from plasma after extravascular administration
Pharmacokinetic- Vz/F
Time frame: Day 1 and Day 7- 10
Estimation of apparent volume of distribution during the terminal phase
Pharmacokinetic- Cmax
Time frame: Day 1 and Day 7
Estimation of observed maximum plasma concentration
Pharmacokinetic- Tmax
Time frame: Day 1 and Day 7
Estimation of time to Cmax
Pharmacokinetic- t1/2
Time frame: Day 1 and Day 7- 10
Description: Estimation of terminal elimination half-life
1 secondary outcome
Adverse Events (AEs)
Time frame: From enrollment until at least 28 days after completion of study 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 8 May 2020.
- Individual participant dataSharing planned: Yes. Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
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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.
Ying Ye, PhD study director
Celgene
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 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 4 inclusion and 3 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 8 May 2020. 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- AUC0-t (time frame: Day 1 and Day 7- 10). The study lists 7 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 8 May 2020.