Clinical Trials/NCT04958291

NCT04958291

Completed

Phase 1

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

Celgene2 sites in 1 country25 target enrollmentAugust 3, 2021

ConditionsHealthy Volunteers

InterventionsCC-99677 Placebo

DrugsCC-99677

Overview

Phase: Phase 1
Intervention: CC-99677
Conditions: Healthy Volunteers
Sponsor: Celgene
Enrollment: 25
Locations: 2
Primary Endpoint: Incidence of Adverse Events (AEs)
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 3, 2021

End Date

December 7, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Celgene

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

Administration of Dose A of CC-99677 or Placebo

Intervention: CC-99677

Administration of Dose A of CC-99677 or Placebo

Intervention: Placebo

Administration of Dose B of CC-99677 or Placebo

Intervention: CC-99677

Administration of Dose B of CC-99677 or Placebo

Intervention: Placebo

Administration of Dose C of CC-99677 or Placebo

Intervention: CC-99677

Administration of Dose C of CC-99677 or Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

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

Pharmacokinetics - Vz/F for CC-99677(Up to 48 hours after last dose of study treatment)
Pharmacokinetics - DF for CC-99677(Up to 48 hours after last dose of study treatment)
Pharmacokinetics - AUCtau for CC0782951(Up to 48 hours after last dose of study treatment)
Pharmacokinetics - Ctau for CC0782951(Up to 48 hours after last dose of study treatment)
Pharmacokinetics - Ctrough for CC-99677(Up to 48 hours after last dose of study treatment)
Pharmacokinetics - Css-avg for CC-99677(Up to 48 hours after last dose of study treatment)
Pharmacokinetics - Cmax for CC-99677(Up to 48 hours after last dose of study treatment)
Pharmacokinetics - Cmax for CC0782951(Up to 48 hours after last dose of study treatment)
Apparent terminal phase half-life(Up to 48 hours after last dose of study treatment)
Pharmacokinetics - AUC0-ti for CC0782951(Up to 48 hours after last dose of study treatment)
Pharmacokinetics - Css-avg for CC0782951(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 - 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)
Pharmacokinetics - AI_Cmax for CC-99677(Up to 48 hours after last dose of study treatment)
Pharmacokinetics - AI_AUC for CC-99677(Up to 48 hours after last dose of study treatment)
Pharmacokinetics - tmax for CC0782951(Up to 48 hours after last dose of study treatment)
Pharmacokinetics - DF for CC0782951(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 - t½ for CC-99677(Up to 48 hours after last dose of study treatment)
Pharmacokinetics - t½ for CC0782951(Up to 48 hours after last dose of study treatment)
Pharmacokinetics - Ctrough for CC0782951(Up to 48 hours after last dose of study treatment)
Pharmacokinetics - AI_Cmax for CC0782951(Up to 48 hours after last dose of study treatment)
Pharmacokinetics - AI_AUC for CC0782951(Up to 48 hours after last dose of study treatment)