Healthy VolunteersPhase 1NCT04958291
Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CC-99677 in Healthy Adult Japanese Participants.
A Phase 1 study testing CC-99677 in people with Healthy Volunteers, run by Celgene at 2 sites in United States.
Trial summary
This study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and pharmacogenomics (PG) of multiple doses of CC-99677 in healthy Japanese adult participants. This study will be placebo-controlled to appropriately characterize the safety and tolerability of CC-99677. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- CC-99677
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Aug 2021to 7 Dec 2021
- 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
- Participants must satisfy the following criteria to be enrolled in the study:
- Participant is ≥ 18 and ≤ 55 years of age at the time of signing the informed consent form (ICF).
- Japanese participants must have both paternal and both maternal grandparents be ethnically Japanese.
- Participants must adhere to protocol-specified contraception requirements.
- Participant has a body mass index (BMI) ≥ 18 and ≤ 33 kg/m2 at screening.
- Participant has physical exam, vital signs, clinical laboratory safety and other medical test results that are within normal limits, considered not clinically significant by the Investigator, or within other parameters specified in the protocol.
Who cannot join
- The presence of any of the following will exclude a participant from enrollment:
- Participant has any significant 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 participant from participating in the study.
- Participant has any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study.
- Participant is pregnant or breastfeeding.
- Participant 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).
- Participant 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. Exceptions may apply on a case-by-case basis if considered not to interfere with the study objectives as agreed to by the Investigator and Sponsor's Medical Monitor.
Show all 21Show fewer
- Participant 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. Exceptions may apply on a case-by-case basis if considered not to interfere with the study objectives as agreed to by the Investigator and Sponsor's Medical Monitor.
- Participant has used CYP3A inducers and/or inhibitors (including St. John's Wort) within 30 days preceding the first dose administration.
- Participant has any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism, or excretion, e.g., bariatric procedure. Appendectomy and cholecystectomy are acceptable. Other previous surgeries may be acceptable with concurrence of the Sponsor's Medical Monitor.
- Participant donated blood or serum within 8 weeks before the first dose administration to a blood bank or blood donation center.
- Participant smokes > 10 cigarettes per day, or the equivalent in other tobacco products (self-reported).
- Participant has received immunization with a live or live attenuated vaccine within 2 months prior to the first dose administration or is planning to receive immunization with a live or live attenuated vaccine for 2 months following the last dose administration.
- Participant has a history of Gilbert's syndrome or has laboratory findings at screening that, in the opinion of the Investigator, are indicative of Gilbert's syndrome.
- Participant has a history of incompletely treated Mycobacterium tuberculosis (TB) infection, or has a positive QuantiFERON®-TB Gold (or equivalent) test at screening or 2 successive indeterminate QuantiFERON®-TB Gold (or equivalent) tests at screening.
- Participants with clinical symptoms or signs (including febrile illness) suggesting active, subacute, or unresolved chronic infection.
- Previous SARS-CoV-2 infection within 4 weeks prior to screening.
- Symptoms must have completely resolved and, based on Investigator assessment in consultation with the Sponsor's Medical Monitor, there are no sequelae that would place the participant at a higher risk of receiving IP.
- Participant has previously been exposed to CC-99677 (e.g., in a prior clinical trial).
- Participant has a history of photosensitivity to medications.
- Participant is part of the study site staff personnel or a family member of the study site staff.
- Any other exclusion criteria specified in the protocol that will be made known to participants prior to signing ICF.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Collaborative Neuroscience Network, LLC
Long Beach, California, 90806
Local Institution - 001
Long Beach, California, 90806
About this study
Official title: A Phase 1 Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of CC 99677 in Healthy Adult Japanese Subjects
This study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and pharmacogenomics (PG) of multiple doses of CC-99677 in healthy Japanese adult participants. This study will be placebo-controlled to appropriately characterize the safety and tolerability of CC-99677.
- Conditions
- Healthy Volunteers
- Being tested
- CC-99677, Placebo
- Keywords
- Healthy Volunteers, CC-99677, Phase 1, Japanese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-99677Drug
CC-99677
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Administration of Dose A of CC-99677 or Placebo | Experimental | Administration of Dose A of CC-99677 or Placebo Receives: Drug: CC-99677; Other: Placebo |
| Administration of Dose B of CC-99677 or Placebo | Experimental | Administration of Dose B of CC-99677 or Placebo Receives: Drug: CC-99677; Other: Placebo |
| Administration of Dose C of CC-99677 or Placebo | Experimental | Administration of Dose C of CC-99677 or Placebo Receives: Drug: CC-99677; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs)
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
Measured: From enrollment until at least 28 days after last dose of study treatment
Secondary outcomes (24)
Pharmacokinetics - Cmax for CC-99677
Maximum observed plasma concentration within a dosing interval
Measured: Up to 48 hours after last dose of study treatment
Pharmacokinetics - tmax for CC-99677
Time of maximum observed plasma concentration within a dosing interval
Measured: Up to 48 hours after last dose of study treatment
Pharmacokinetics - AUCtau for CC-99677
Area under the plasma concentration-time curve within a dosing interval
Measured: Up to 48 hours after last dose of study treatment
Pharmacokinetics - AUC0-ti for CC-99677
Area under the plasma concentration-time curve from time zero to time ti within a dosing interval
Measured: Up to 48 hours after last dose of study treatment
Pharmacokinetics - Ctau for CC-99677
Concentration at the end of a dosing interval
Measured: Up to 48 hours after last dose of study treatment
Pharmacokinetics - Ctrough for CC-99677
Trough observed plasma concentration
Measured: Up to 48 hours after last dose of study treatment
Pharmacokinetics - t½ for CC-99677
Apparent terminal phase half-life
Measured: Up to 48 hours after last dose of study treatment
Apparent terminal phase half-life
Apparent total body clearance
Measured: Up to 48 hours after last dose of study treatment
Pharmacokinetics - Vz/F for CC-99677
Apparent volume of distribution of terminal phase
Measured: Up to 48 hours after last dose of study treatment
Pharmacokinetics - DF for CC-99677
Degree of fluctuation
Measured: Up to 48 hours after last dose of study treatment
Pharmacokinetics - Css-avg for CC-99677
Average concentration within a dosing interval
Measured: Up to 48 hours after last dose of study treatment
Pharmacokinetics - AI_Cmax for CC-99677
Ratio of Cmax at steady-state to Cmax after the first dose
Measured: Up to 48 hours after last dose of study treatment
Pharmacokinetics - AI_AUC for CC-99677
Ratio of AUC(TAU) at steady-state to AUC(TAU) after the first dose
Measured: Up to 48 hours after last dose of study treatment
Pharmacokinetics - Cmax for CC0782951
Maximum observed plasma concentration within a dosing interval
Measured: Up to 48 hours after last dose of study treatment
Pharmacokinetics - tmax for CC0782951
Time of maximum observed plasma concentration within a dosing interval
Measured: Up to 48 hours after last dose of study treatment
Pharmacokinetics - AUCtau for CC0782951
Area under the plasma concentration-time curve within a dosing interval
Measured: Up to 48 hours after last dose of study treatment
Pharmacokinetics - AUC0-ti for CC0782951
Area under the plasma concentration-time curve from time zero to time ti within a dosing interval
Measured: Up to 48 hours after last dose of study treatment
Pharmacokinetics - Ctau for CC0782951
Concentration at the end of a dosing interval
Measured: Up to 48 hours after last dose of study treatment
Pharmacokinetics - Ctrough for CC0782951
Trough observed plasma concentration
Measured: Up to 48 hours after last dose of study treatment
Pharmacokinetics - t½ for CC0782951
Apparent terminal phase half-life
Measured: Up to 48 hours after last dose of study treatment
Pharmacokinetics - DF for CC0782951
Degree of fluctuation
Measured: Up to 48 hours after last dose of study treatment
Pharmacokinetics - Css-avg for CC0782951
Average concentration within a dosing interval
Measured: Up to 48 hours after last dose of study treatment
Pharmacokinetics - AI_Cmax for CC0782951
Ratio of Cmax at steady-state to Cmax after the first dose
Measured: Up to 48 hours after last dose of study treatment
Pharmacokinetics - AI_AUC for CC0782951
Ratio of AUC(TAU) at steady-state to AUC(TAU) after the first dose
Measured: Up to 48 hours after last dose 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 posted12 Jul 2021
- Study start3 Aug 2021
- Primary completion6 Dec 2021
- Study completion7 Dec 2021
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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04958291
- Sponsor's protocol ID
- CC-99677-CP-004
- Status last verified
- Nov 2022
- First submitted
- 1 Jul 2021
- Last updated
- 4 Nov 2022
- 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 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of CC 99677 in Healthy Adult Japanese Subjects
- ClinicalTrials.gov ID
- NCT04958291
- Acronym / sponsor ID
- CC-99677-CP-004
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Volunteers, CC-99677, Phase 1, Japanese
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 3 Aug 2021 (actual)
- Primary completion
- 6 Dec 2021 (actual)
- Study completion
- 7 Dec 2021 (actual)
- First posted
- 12 Jul 2021 (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 study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and pharmacogenomics (PG) of multiple doses of CC-99677 in healthy Japanese adult participants. This study will be placebo-controlled to appropriately characterize the safety and tolerability of CC-99677.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Administration of Dose A of CC-99677 or Placebo | Experimental | Drug: CC-99677, Other: PlaceboAdministration of Dose A of CC-99677 or Placebo |
| Administration of Dose B of CC-99677 or Placebo | Experimental | Drug: CC-99677, Other: PlaceboAdministration of Dose B of CC-99677 or Placebo |
| Administration of Dose C of CC-99677 or Placebo | Experimental | Drug: CC-99677, Other: PlaceboAdministration of Dose C of CC-99677 or Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participant is ≥ 18 and ≤ 55 years of age at the time of signing the informed consent form (ICF).
- Japanese participants must have both paternal and both maternal grandparents be ethnically Japanese.
- Participants must adhere to protocol-specified contraception requirements.
- Participant has a body mass index (BMI) ≥ 18 and ≤ 33 kg/m2 at screening.
- Participant has physical exam, vital signs, clinical laboratory safety and other medical test results that are within normal limits, considered not clinically significant by the Investigator, or within other parameters specified in the protocol.
Key exclusion criteria (21 listed)
- Participant has any significant 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 participant from participating in the study.
- Participant has any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he/she were to participate in the study.
- Participant is pregnant or breastfeeding.
- Participant 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).
- Participant 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. Exceptions may apply on a case-by-case basis if considered not to interfere with the study objectives as agreed to by the Investigator and Sponsor's Medical Monitor.
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-99677CC-99677 | Drug | Administration of Dose A of CC-99677 or Placebo, Administration of Dose B of CC-99677 or Placebo, Administration of Dose C of CC-99677 or Placebo |
| PlaceboPlacebo | Other | Administration of Dose A of CC-99677 or Placebo, Administration of Dose B of CC-99677 or Placebo, Administration of Dose C of CC-99677 or Placebo |
Primary outcome
Incidence of Adverse Events (AEs)
Time frame: From enrollment until at least 28 days after last dose of study treatment
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
24 secondary outcomes
Pharmacokinetics - Cmax for CC-99677
Time frame: Up to 48 hours after last dose of study treatment
Pharmacokinetics - tmax for CC-99677
Time frame: Up to 48 hours after last dose of study treatment
Pharmacokinetics - AUCtau for CC-99677
Time frame: Up to 48 hours after last dose of study treatment
Pharmacokinetics - AUC0-ti for CC-99677
Time frame: Up to 48 hours after last dose of study treatment
Pharmacokinetics - Ctau for CC-99677
Time frame: Up to 48 hours after last dose of study treatment
Pharmacokinetics - Ctrough for CC-99677
Time frame: Up to 48 hours after last dose of study treatment
Pharmacokinetics - t½ for CC-99677
Time frame: Up to 48 hours after last dose of study treatment
Apparent terminal phase half-life
Time frame: Up to 48 hours after last dose of study treatment
Pharmacokinetics - Vz/F for CC-99677
Time frame: Up to 48 hours after last dose of study treatment
Pharmacokinetics - DF for CC-99677
Time frame: Up to 48 hours after last dose of study treatment
Pharmacokinetics - Css-avg for CC-99677
Time frame: Up to 48 hours after last dose of study treatment
Pharmacokinetics - AI_Cmax for CC-99677
Time frame: Up to 48 hours after last dose of study treatment
Pharmacokinetics - AI_AUC for CC-99677
Time frame: Up to 48 hours after last dose of study treatment
Pharmacokinetics - Cmax for CC0782951
Time frame: Up to 48 hours after last dose of study treatment
Pharmacokinetics - tmax for CC0782951
Time frame: Up to 48 hours after last dose of study treatment
Pharmacokinetics - AUCtau for CC0782951
Time frame: Up to 48 hours after last dose of study treatment
Pharmacokinetics - AUC0-ti for CC0782951
Time frame: Up to 48 hours after last dose of study treatment
Pharmacokinetics - Ctau for CC0782951
Time frame: Up to 48 hours after last dose of study treatment
Pharmacokinetics - Ctrough for CC0782951
Time frame: Up to 48 hours after last dose of study treatment
Pharmacokinetics - t½ for CC0782951
Time frame: Up to 48 hours after last dose of study treatment
Pharmacokinetics - DF for CC0782951
Time frame: Up to 48 hours after last dose of study treatment
Pharmacokinetics - Css-avg for CC0782951
Time frame: Up to 48 hours after last dose of study treatment
Pharmacokinetics - AI_Cmax for CC0782951
Time frame: Up to 48 hours after last dose of study treatment
Pharmacokinetics - AI_AUC for CC0782951
Time frame: Up to 48 hours after last dose 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 4 Nov 2022.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- 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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
2 sites 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-99677 in people with Healthy Volunteers, run by Celgene at 2 sites 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 6 inclusion and 21 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 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Incidence of Adverse Events (AEs) (time frame: From enrollment until at least 28 days after last dose of study treatment). 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 4 Nov 2022.