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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05099822

Enrollment

Registered

2021-10-29

Start date

2020-03-13

Completion date

2022-07-11

Last updated

2023-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

CC-97489, Healthy Adult, Phase1

Brief summary

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

Interventions

DRUGCC-97489

Specified dose on specified days

OTHERPlacebo

Specified dose on specified days

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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/

Design outcomes

Primary

Measure	Time frame
Incidence of clinically significant changes in clinical laboratory results: Hematology tests	Day 18
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: Clinical Chemistry tests	Day 18
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests	Day 18

Secondary

Measure	Time frame
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
Pharmacokinetics - Maximum observed plasma concentration (Cmax)	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
Pharmacodynamics: Peripheral blood mononuclear cell (PBMC) fatty acid amide hydrolase (FAAH) inhibition	Up to 168 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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026