Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CC-97489 in Healthy Adult Participants

NCT05099822 | Terminated Phase 1

• 2 other identifiers: CC-97489-CP-0012019-003458-10
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the safety, tolerability, of CC-97489

Conditions

Healthy Volunteers

Keywords

CC-97489; Healthy Adult; Phase1

Outcome Measures

Primary Outcomes (10)

• Incidence of Adverse Events (AEs)

  28 days after the last dose

• Incidence of Serious Adverse Events (SAEs)

  28 days after the last dose

• Number of participants with clinically significant changes in electrocardiogram parameters

  Day 21

• Incidence of clinically significant changes in vital signs: Body temperature

  Day 21

• Incidence of clinically significant changes in vital signs: Respiratory rate

  Day 21

• Incidence of clinically significant changes in vital signs: Blood pressure

  Day 21

• Incidence of clinically significant changes in vital signs: Heart rate

  Day 21

• Incidence of clinically significant changes in clinical laboratory results: Hematology tests

  Day 18

• Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests

  Day 18

• Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests

  Day 18

Secondary Outcomes (15)

• Pharmacokinetics - Maximum observed plasma concentration (Cmax)

  Up to 96 hours after the last dose of study drug

• Pharmacokinetics - Minimum plasma drug concentration (Cmin)

  Up to 96 hours after the last dose of study drug

• Pharmacokinetics - Time to maximum observed plasma concentration (Tmax)

  Up to 96 hours after the last dose of study drug

• Pharmacokinetics - Area under the plasma concentration (AUC)-time curve from time zero extrapolated to infinity (AUC0-∞)

  Up to 96 hours after the last dose of study drug

• Pharmacokinetics - Area under the plasma concentration-time curve from time zero to time t, where t is the time point of the last measurable concentration (AUC0-t)

  Up to 96 hours after the last dose of study drug

Study Arms (2)

Administration of CC-97489

EXPERIMENTAL

Drug: CC-97489

Administration of Placebo

EXPERIMENTAL

Other: Placebo

Interventions

CC-97489 DRUG

Specified dose on specified days

Also known as: BMS-986368

Administration of CC-97489

Placebo OTHER

Specified dose on specified days

Administration of Placebo

Eligibility Criteria

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

You may qualify if:

• In good health, as determined by the investigator based on past medical history, physical examination, vital signs and clinical laboratory safety tests at screening.
• Body mass index (BMI) ≥ 18 and ≤ 33 kg/m\^2, inclusive. BMI = weight (kg)/(height \[m\])\^2

You may not qualify if:

• Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, echocardiogram (ECG), or clinical laboratory determinations beyond what is consistent with healthy participants

Sponsors & Collaborators

• Celgene: lead

Study Sites (1)

Local Institution - 001

Leuven, Vlaams Brabant, 3000, Belgium

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: October 29, 2021
• Study Start: March 13, 2020
• Primary Completion: July 11, 2022
• Study Completion: July 11, 2022
• Last Updated: December 14, 2023

Record last verified: 2023-12

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

BE (1)