Clinical trial NCT05099822: Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CC-97489 in Healthy Adult Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: CC-97489
Healthy Adult
Phase1
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2021-10-29
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: 28 days after the last dose
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: 28 days after the last dose
measure: Number of participants with clinically significant changes in electrocardiogram parameters
timeFrame: Day 21
measure: Incidence of clinically significant changes in vital signs: Body temperature
timeFrame: Day 21
measure: Incidence of clinically significant changes in vital signs: Respiratory rate
timeFrame: Day 21
measure: Incidence of clinically significant changes in vital signs: Blood pressure
timeFrame: Day 21
measure: Incidence of clinically significant changes in vital signs: Heart rate
timeFrame: Day 21
measure: Incidence of clinically significant changes in clinical laboratory results: Hematology tests
timeFrame: Day 18
measure: Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
timeFrame: Day 18
measure: Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
timeFrame: Day 18
Secondary outcomes:
measure: Pharmacokinetics - Maximum observed plasma concentration (Cmax)
timeFrame: Up to 96 hours after the last dose of study drug
measure: Pharmacokinetics - Minimum plasma drug concentration (Cmin)
timeFrame: Up to 96 hours after the last dose of study drug
measure: Pharmacokinetics - Time to maximum observed plasma concentration (Tmax)
timeFrame: Up to 96 hours after the last dose of study drug
measure: Pharmacokinetics - Area under the plasma concentration (AUC)-time curve from time zero extrapolated to infinity (AUC0-∞)
timeFrame: Up to 96 hours after the last dose of study drug
measure: 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)
timeFrame: Up to 96 hours after the last dose of study drug
measure: Pharmacokinetics - Area under the plasma concentration-time curve from time zero to 24 hours postdose (AUC0-24)
timeFrame: Up to 96 hours after the last dose of study drug
measure: Pharmacokinetics - Area under the plasma concentration-time curve from time zero to tau (τ) where τ is the dosing interval (AUC0- 0-τ)
timeFrame: Up to 96 hours after the last dose of study drug
measure: Pharmacokinetics - Terminal elimination half-life in plasma (t½,z)
timeFrame: Up to 96 hours after the last dose of study drug
measure: Pharmacokinetics - Apparent total plasma clearance when dosed orally (CL/F)
timeFrame: Up to 96 hours after the last dose of study drug
measure: Pharmacokinetics - Apparent total volume of distribution when dosed orally (Vz/F)
timeFrame: Up to 96 hours after the last dose of study drug
measure: Pharmacokinetics - Ratio of accumulation based on Day 1 and Day 14 AUC0- 0-τ and Cmax, as appropriate (Rac)
timeFrame: Up to 96 hours after the last dose of study drug
measure: Pharmacodynamics - Evaluation of monoacylglycerol lipase (MGLL) enzymatic inhibition by CC-97489 in peripheral blood mononuclear cells (PBMCs)
timeFrame: Up to 168 hours after the last dose of study drug
measure: Pharmacodynamics: Peripheral blood mononuclear cell (PBMC) fatty acid amide hydrolase (FAAH) inhibition
timeFrame: Up to 168 hours after the last dose of study drug
measure: Pharmacodynamics - Measurement of : plasma and whole-blood anandamide (AEA) levels
timeFrame: Up to 168 hours after the last dose of study drug
measure: Pharmacodynamics - Measurement of plasma and whole-blood 2-arachidonoylglycerol (2-AG) levels
timeFrame: Up to 168 hours after the last dose of study drug
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Local Institution - 001
state: Vlaams Brabant
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: