Skip to main content
OpenTrials
Completed

NCT Number: NCT04958291

Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CC-99677 in Healthy Adult Japanese Participants.

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Collaborative Neuroscience Network, LLC, Long Beach, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.
  • 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.

a. 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.

Treatment and study plan

CC-99677

Drug

CC-99677

Placebo

Other

Placebo

Primary outcomes

  1. 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.

Secondary outcomes

  1. Pharmacokinetics - Cmax for CC-99677

    Time frame: Up to 48 hours after last dose of study treatment

    Maximum observed plasma concentration within a dosing interval

  2. Pharmacokinetics - tmax for CC-99677

    Time frame: Up to 48 hours after last dose of study treatment

    Time of maximum observed plasma concentration within a dosing interval

  3. Pharmacokinetics - AUCtau for CC-99677

    Time frame: Up to 48 hours after last dose of study treatment

    Area under the plasma concentration-time curve within a dosing interval

  4. Pharmacokinetics - AUC0-ti for CC-99677

    Time frame: Up to 48 hours after last dose of study treatment

    Area under the plasma concentration-time curve from time zero to time ti within a dosing interval

  5. Pharmacokinetics - Ctau for CC-99677

    Time frame: Up to 48 hours after last dose of study treatment

    Concentration at the end of a dosing interval

  6. Pharmacokinetics - Ctrough for CC-99677

    Time frame: Up to 48 hours after last dose of study treatment

    Trough observed plasma concentration

  7. Pharmacokinetics - t½ for CC-99677

    Time frame: Up to 48 hours after last dose of study treatment

    Apparent terminal phase half-life

  8. Apparent terminal phase half-life

    Time frame: Up to 48 hours after last dose of study treatment

    Apparent total body clearance

  9. Pharmacokinetics - Vz/F for CC-99677

    Time frame: Up to 48 hours after last dose of study treatment

    Apparent volume of distribution of terminal phase

  10. Pharmacokinetics - DF for CC-99677

    Time frame: Up to 48 hours after last dose of study treatment

    Degree of fluctuation

  11. Pharmacokinetics - Css-avg for CC-99677

    Time frame: Up to 48 hours after last dose of study treatment

    Average concentration within a dosing interval

  12. Pharmacokinetics - AI_Cmax for CC-99677

    Time frame: Up to 48 hours after last dose of study treatment

    Ratio of Cmax at steady-state to Cmax after the first dose

  13. Pharmacokinetics - AI_AUC for CC-99677

    Time frame: Up to 48 hours after last dose of study treatment

    Ratio of AUC(TAU) at steady-state to AUC(TAU) after the first dose

  14. Pharmacokinetics - Cmax for CC0782951

    Time frame: Up to 48 hours after last dose of study treatment

    Maximum observed plasma concentration within a dosing interval

  15. Pharmacokinetics - tmax for CC0782951

    Time frame: Up to 48 hours after last dose of study treatment

    Time of maximum observed plasma concentration within a dosing interval

  16. Pharmacokinetics - AUCtau for CC0782951

    Time frame: Up to 48 hours after last dose of study treatment

    Area under the plasma concentration-time curve within a dosing interval

  17. Pharmacokinetics - AUC0-ti for CC0782951

    Time frame: Up to 48 hours after last dose of study treatment

    Area under the plasma concentration-time curve from time zero to time ti within a dosing interval

  18. Pharmacokinetics - Ctau for CC0782951

    Time frame: Up to 48 hours after last dose of study treatment

    Concentration at the end of a dosing interval

  19. Pharmacokinetics - Ctrough for CC0782951

    Time frame: Up to 48 hours after last dose of study treatment

    Trough observed plasma concentration

  20. Pharmacokinetics - t½ for CC0782951

    Time frame: Up to 48 hours after last dose of study treatment

    Apparent terminal phase half-life

  21. Pharmacokinetics - DF for CC0782951

    Time frame: Up to 48 hours after last dose of study treatment

    Degree of fluctuation

  22. Pharmacokinetics - Css-avg for CC0782951

    Time frame: Up to 48 hours after last dose of study treatment

    Average concentration within a dosing interval

  23. Pharmacokinetics - AI_Cmax for CC0782951

    Time frame: Up to 48 hours after last dose of study treatment

    Ratio of Cmax at steady-state to Cmax after the first dose

  24. Pharmacokinetics - AI_AUC for CC0782951

    Time frame: Up to 48 hours after last dose of study treatment

    Ratio of AUC(TAU) at steady-state to AUC(TAU) after the first dose

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study title

A Phase 1 Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of CC 99677 in Healthy Adult Japanese Subjects

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 12, 2021
Registry last updated
Nov 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.