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

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single-center, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of CC-97489 in Healthy Adult Subjects

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

Study Overview

• Status: Terminated
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: Placebo; Drug: CC-97489

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Vlaams Brabant
    • Leuven, Vlaams Brabant, Belgium, 3000
      • Local Institution - 001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Other protocol-defined inclusion/exclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Administration of CC-97489	Drug: CC-97489; Specified dose on specified days; Other Names: BMS-986368
Experimental: Administration of Placebo	Other: Placebo; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Pharmacokinetics - Area under the plasma concentration-time curve from time zero to 24 hours postdose (AUC0-24)	Up to 96 hours after the last dose of study drug
Pharmacokinetics - Area under the plasma concentration-time curve from time zero to tau (τ) where τ is the dosing interval (AUC0- 0-τ)	Up to 96 hours after the last dose of study drug
Pharmacokinetics - Terminal elimination half-life in plasma (t½,z)	Up to 96 hours after the last dose of study drug
Pharmacokinetics - Apparent total plasma clearance when dosed orally (CL/F)	Up to 96 hours after the last dose of study drug
Pharmacokinetics - Apparent total volume of distribution when dosed orally (Vz/F)	Up to 96 hours after the last dose of study drug
Pharmacokinetics - Ratio of accumulation based on Day 1 and Day 14 AUC0- 0-τ and Cmax, as appropriate (Rac)	Up to 96 hours after the last dose of study drug
Pharmacodynamics - Evaluation of monoacylglycerol lipase (MGLL) enzymatic inhibition by CC-97489 in peripheral blood mononuclear cells (PBMCs)	Up to 168 hours after the last dose of study drug
Pharmacodynamics: Peripheral blood mononuclear cell (PBMC) fatty acid amide hydrolase (FAAH) inhibition	Up to 168 hours after the last dose of study drug
Pharmacodynamics - Measurement of : plasma and whole-blood anandamide (AEA) levels	Up to 168 hours after the last dose of study drug
Pharmacodynamics - Measurement of plasma and whole-blood 2-arachidonoylglycerol (2-AG) levels	Up to 168 hours after the last dose of study drug

Collaborators and Investigators

• Sponsor: Celgene
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2020
• Primary Completion (Actual): July 11, 2022
• Study Completion (Actual): July 11, 2022

Study Registration Dates

• First Submitted: September 9, 2021
• First Submitted That Met QC Criteria: October 19, 2021
• First Posted (Actual): October 29, 2021

Study Record Updates

• Last Update Posted (Estimated): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Healthy Adult; Phase1; CC-97489
• Other Study ID Numbers: CC-97489-CP-001; 2019-003458-10 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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/

• IPD Sharing Time Frame: See Plan Description
• IPD Sharing Access Criteria: See Plan Description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No