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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05099822
• Other study ID #: CC-97489-CP-001
• Secondary ID: 2019-003458-10
• Status: Terminated
• Phase: Phase 1
• Start date: March 13, 2020
• Est. completion date: July 11, 2022

Study information

• Verified date: December 2023
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 84
• Est. completion date: July 11, 2022
• Est. primary completion date: July 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• CC-97489
Specified dose on specified days

Other:
• Placebo
Specified dose on specified days

Locations

Country	Name	City	State
Belgium	Local Institution - 001	Leuven	Vlaams Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events (AEs)		28 days after the last dose
Primary	Incidence of Serious Adverse Events (SAEs)		28 days after the last dose
Primary	Number of participants with clinically significant changes in electrocardiogram parameters		Day 21
Primary	Incidence of clinically significant changes in vital signs: Body temperature		Day 21
Primary	Incidence of clinically significant changes in vital signs: Respiratory rate		Day 21
Primary	Incidence of clinically significant changes in vital signs: Blood pressure		Day 21
Primary	Incidence of clinically significant changes in vital signs: Heart rate		Day 21
Primary	Incidence of clinically significant changes in clinical laboratory results: Hematology tests		Day 18
Primary	Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests		Day 18
Primary	Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests		Day 18
Secondary	Pharmacokinetics - Maximum observed plasma concentration (Cmax)		Up to 96 hours after the last dose of study drug
Secondary	Pharmacokinetics - Minimum plasma drug concentration (Cmin)		Up to 96 hours after the last dose of study drug
Secondary	Pharmacokinetics - Time to maximum observed plasma concentration (Tmax)		Up to 96 hours after the last dose of study drug
Secondary	Pharmacokinetics - Area under the plasma concentration (AUC)-time curve from time zero extrapolated to infinity (AUC0-8)		Up to 96 hours after the last dose of study drug
Secondary	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
Secondary	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
Secondary	Pharmacokinetics - Area under the plasma concentration-time curve from time zero to tau (t) where t is the dosing interval (AUC0- 0-t)		Up to 96 hours after the last dose of study drug
Secondary	Pharmacokinetics - Terminal elimination half-life in plasma (t½,z)		Up to 96 hours after the last dose of study drug
Secondary	Pharmacokinetics - Apparent total plasma clearance when dosed orally (CL/F)		Up to 96 hours after the last dose of study drug
Secondary	Pharmacokinetics - Apparent total volume of distribution when dosed orally (Vz/F)		Up to 96 hours after the last dose of study drug
Secondary	Pharmacokinetics - Ratio of accumulation based on Day 1 and Day 14 AUC0- 0-t and Cmax, as appropriate (Rac)		Up to 96 hours after the last dose of study drug
Secondary	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
Secondary	Pharmacodynamics: Peripheral blood mononuclear cell (PBMC) fatty acid amide hydrolase (FAAH) inhibition		Up to 168 hours after the last dose of study drug
Secondary	Pharmacodynamics - Measurement of : plasma and whole-blood anandamide (AEA) levels		Up to 168 hours after the last dose of study drug
Secondary	Pharmacodynamics - Measurement of plasma and whole-blood 2-arachidonoylglycerol (2-AG) levels		Up to 168 hours after the last dose of study drug

External Links

•   BMS Clinical Trial Information