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

Phase 1

Terminated

• Conditions: Healthy Volunteers
• Interventions: Other: Placebo; Drug: CC-97489

• Registration Number: NCT05099822
• Lead Sponsor: Celgene

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-13
• Study First Submitted: 2021-09-09
• Study First Submitted QC: 2021-10-19
• Study First Posted: 2021-10-29
• Primary Completion: 2022-07-11
• Study Completion: 2022-07-11
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-08
• Last Update Posted: 2023-12-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 84

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Administration of Placebo	Placebo	-
Administration of CC-97489	CC-97489	-

Primary Outcome Measures

Name	Time	Method
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 clinical laboratory results: Urinalysis tests	Day 18
Incidence of clinically significant changes in vital signs: Heart rate	Day 21
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests	Day 18
Incidence of clinically significant changes in clinical laboratory results: Hematology tests	Day 18

Secondary Outcome Measures

Name	Time	Method
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 - 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 tau (τ) where τ is the dosing interval (AUC0- 0-τ)	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 - 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 - 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 - 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
Pharmacokinetics - Apparent total plasma clearance when dosed orally (CL/F)	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 - Terminal elimination half-life in plasma (t½,z)	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

Trial Locations

Locations (1)

Local Institution - 001; 🇧🇪 Leuven, Vlaams Brabant, Belgium