This study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and pharmacogenomics (PG) of multiple doses of CC-99677 in healthy Japanese adult participants. This study will be placebo-controlled to appropriately characterize the safety and tolerability of CC-99677.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
25
Collaborative Neuroscience Network, LLC
Long Beach, California, United States
Local Institution - 001
Long Beach, California, United States
Incidence of Adverse Events (AEs)
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values regardless of etiology. Any worsening (i.e., any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
Time frame: From enrollment until at least 28 days after last dose of study treatment
Pharmacokinetics - Cmax for CC-99677
Maximum observed plasma concentration within a dosing interval
Time frame: Up to 48 hours after last dose of study treatment
Pharmacokinetics - tmax for CC-99677
Time of maximum observed plasma concentration within a dosing interval
Time frame: Up to 48 hours after last dose of study treatment
Pharmacokinetics - AUCtau for CC-99677
Area under the plasma concentration-time curve within a dosing interval
Time frame: Up to 48 hours after last dose of study treatment
Pharmacokinetics - AUC0-ti for CC-99677
Area under the plasma concentration-time curve from time zero to time ti within a dosing interval
Time frame: Up to 48 hours after last dose of study treatment
Pharmacokinetics - Ctau for CC-99677
Concentration at the end of a dosing interval
Time frame: Up to 48 hours after last dose of study treatment
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Pharmacokinetics - Ctrough for CC-99677
Trough observed plasma concentration
Time frame: Up to 48 hours after last dose of study treatment
Pharmacokinetics - t½ for CC-99677
Apparent terminal phase half-life
Time frame: Up to 48 hours after last dose of study treatment
Apparent terminal phase half-life
Apparent total body clearance
Time frame: Up to 48 hours after last dose of study treatment
Pharmacokinetics - Vz/F for CC-99677
Apparent volume of distribution of terminal phase
Time frame: Up to 48 hours after last dose of study treatment
Pharmacokinetics - DF for CC-99677
Degree of fluctuation
Time frame: Up to 48 hours after last dose of study treatment
Pharmacokinetics - Css-avg for CC-99677
Average concentration within a dosing interval
Time frame: Up to 48 hours after last dose of study treatment
Pharmacokinetics - AI_Cmax for CC-99677
Ratio of Cmax at steady-state to Cmax after the first dose
Time frame: Up to 48 hours after last dose of study treatment
Pharmacokinetics - AI_AUC for CC-99677
Ratio of AUC(TAU) at steady-state to AUC(TAU) after the first dose
Time frame: Up to 48 hours after last dose of study treatment
Pharmacokinetics - Cmax for CC0782951
Maximum observed plasma concentration within a dosing interval
Time frame: Up to 48 hours after last dose of study treatment
Pharmacokinetics - tmax for CC0782951
Time of maximum observed plasma concentration within a dosing interval
Time frame: Up to 48 hours after last dose of study treatment
Pharmacokinetics - AUCtau for CC0782951
Area under the plasma concentration-time curve within a dosing interval
Time frame: Up to 48 hours after last dose of study treatment
Pharmacokinetics - AUC0-ti for CC0782951
Area under the plasma concentration-time curve from time zero to time ti within a dosing interval
Time frame: Up to 48 hours after last dose of study treatment
Pharmacokinetics - Ctau for CC0782951
Concentration at the end of a dosing interval
Time frame: Up to 48 hours after last dose of study treatment
Pharmacokinetics - Ctrough for CC0782951
Trough observed plasma concentration
Time frame: Up to 48 hours after last dose of study treatment
Pharmacokinetics - t½ for CC0782951
Apparent terminal phase half-life
Time frame: Up to 48 hours after last dose of study treatment
Pharmacokinetics - DF for CC0782951
Degree of fluctuation
Time frame: Up to 48 hours after last dose of study treatment
Pharmacokinetics - Css-avg for CC0782951
Average concentration within a dosing interval
Time frame: Up to 48 hours after last dose of study treatment
Pharmacokinetics - AI_Cmax for CC0782951
Ratio of Cmax at steady-state to Cmax after the first dose
Time frame: Up to 48 hours after last dose of study treatment
Pharmacokinetics - AI_AUC for CC0782951
Ratio of AUC(TAU) at steady-state to AUC(TAU) after the first dose
Time frame: Up to 48 hours after last dose of study treatment