This is a two-part study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of CC-92480 and explore the effect of food on the bioavailability of CC-92480 in healthy subjects. Part 1: Part 1 is a single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK, and pharmacodynamics (PD) of CC-92480 following administration of single oral doses in healthy adult subjects. Part 1 will consist of escalating single doses in sequential groups. Approximately 40 subjects will be enrolled into 5 planned dose level cohorts. Each dose level cohort will consist of 8 subjects; 6 subjects will receive CC-92480 and 2 subjects will receive placebo according to the randomization schedule. Part 2 Part 2 is a single-center, open-label, randomized, 2-period, 2-way crossover study to explore the effect of food (Food and Drug Administration \[FDA\] standard high-fat breakfast) on the single-dose PK of CC-92480 in healthy adult subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
56
Part 1 dose escalation
CC-92480
Covance-Daytona Beach
Daytona Beach, Florida, United States
Pharmacokinetics- Cmax Part 1
Maximum plasma concentration of drug
Time frame: Day 1
Pharmacokinetics- Tmax Part 1
Time to maximum plasma concentration
Time frame: Day 1
Pharmacokinetics- AUC0-∞ Part 1
Area under the plasma concentration-time curve from time zero extrapolated to infinity
Time frame: Up to 72 hours after dose administration
Pharmacokinetics- AUC0-t Part 1
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration
Time frame: Up to 72 hours after dose administration
Pharmacokinetics- AUC0-24 Part 1
Area under the plasma concentration-time curve from time zero to 24 hours postdose
Time frame: Up to 24 hours after dose administration
Pharmacokinetics- AUC-t½ Part 1
Terminal half-life
Time frame: Up to 72 hours after dose administration
Pharmacokinetics- CL/F Part 1
Apparent total plasma clearance
Time frame: Up to 72 hours after dose administration
Pharmacokinetics- Vz/F Part 1
Apparent total volume of distribution
Time frame: Up to 72 hours after dose administration
Pharmacokinetics- Cmax Part 2
Maximum plasma concentration of drug
Time frame: Day 1
Pharmacokinetics- Tmax Part 2
Time to maximum plasma concentration
Time frame: Day 1
Pharmacokinetics- AUC0-∞ Part 2
Area under the plasma concentration-time curve from time zero extrapolated to infinity
Time frame: Up to 72 hours after dose administration
Pharmacokinetics- AUC0-t Part 2
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration
Time frame: Up to 72 hours after dose administration
Pharmacokinetics- AUC0-24 Part 2
Area under the plasma concentration-time curve from time zero to 24 hours post dose
Time frame: Up to 24 hours after dose administration
Pharmacokinetics- AUC-t½ Part 2
Terminal half-life
Time frame: Up to 72 hours after dose administration
Adverse Event(s)
Number of participants with adverse events
Time frame: From enrollment until at least 28 days after completion of study treatment
Effect of CC-92480 on ECG parameters- Part 1
12-lead ECGs extracted from continuous (Holter) recordings will be used to assess effect of CC-92480 on Qt/QTc ECG parameters.
Time frame: Up to day 2
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