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

NCT04958291 | Completed Phase 1 FDA Drug

• 1 other identifier: CC-99677-CP-004
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Healthy Volunteers

Keywords

Healthy Volunteers; CC-99677; Phase 1; Japanese

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment until at least 28 days after last dose of study treatment

Secondary Outcomes (24)

• Pharmacokinetics - Cmax for CC-99677

  Up to 48 hours after last dose of study treatment

• Pharmacokinetics - tmax for CC-99677

  Up to 48 hours after last dose of study treatment

• Pharmacokinetics - AUCtau for CC-99677

  Up to 48 hours after last dose of study treatment

• Pharmacokinetics - AUC0-ti for CC-99677

  Up to 48 hours after last dose of study treatment

• Pharmacokinetics - Ctau for CC-99677

  Up to 48 hours after last dose of study treatment

Study Arms (3)

Administration of Dose A of CC-99677 or Placebo

EXPERIMENTAL

Administration of Dose A of CC-99677 or Placebo

Drug: CC-99677; Other: Placebo

Administration of Dose B of CC-99677 or Placebo

EXPERIMENTAL

Administration of Dose B of CC-99677 or Placebo

Drug: CC-99677; Other: Placebo

Administration of Dose C of CC-99677 or Placebo

EXPERIMENTAL

Administration of Dose C of CC-99677 or Placebo

Drug: CC-99677; Other: Placebo

Interventions

CC-99677 DRUG

CC-99677

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

Placebo OTHER

Placebo

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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celgene: lead

Study Sites (2)

Collaborative Neuroscience Network, LLC

Long Beach, California, 90806, United States

Location

Local Institution - 001

Long Beach, California, 90806, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 12, 2021
• Study Start: August 3, 2021
• Primary Completion: December 6, 2021
• Study Completion: December 7, 2021
• Last Updated: November 4, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (2)