Clinical Trials/NCT05099822

NCT05099822

Terminated

Phase 1

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

Celgene1 site in 1 country84 target enrollmentMarch 13, 2020

ConditionsHealthy Volunteers

InterventionsCC-97489 Placebo

DrugsCC-97489

Overview

Phase: Phase 1
Intervention: CC-97489
Conditions: Healthy Volunteers
Sponsor: Celgene
Enrollment: 84
Locations: 1
Primary Endpoint: Incidence of Adverse Events (AEs)
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

March 13, 2020

End Date

July 11, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Celgene

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Administration of CC-97489

Intervention: CC-97489

Administration of Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Incidence of Adverse Events (AEs)

Time Frame: 28 days after the last dose

Incidence of Serious Adverse Events (SAEs)

Time Frame: 28 days after the last dose

Number of participants with clinically significant changes in electrocardiogram parameters

Time Frame: Day 21

Incidence of clinically significant changes in vital signs: Body temperature

Time Frame: Day 21

Incidence of clinically significant changes in vital signs: Respiratory rate

Time Frame: Day 21

Incidence of clinically significant changes in vital signs: Blood pressure

Time Frame: Day 21

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

Time Frame: Day 18

Incidence of clinically significant changes in vital signs: Heart rate

Time Frame: Day 21

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

Time Frame: Day 18

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

Time Frame: Day 18

Secondary Outcomes

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 - Apparent total plasma clearance when dosed orally (CL/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 - 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)
Pharmacokinetics - Maximum observed plasma concentration (Cmax)(Up to 96 hours after the last dose of study drug)