This is a Phase 1 study that will be conducted in 2 parts. Participants may participate in 1 part only. * Part 1 will be a randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, and PK of CC-92480-02 (Formulation A) administered orally under fasted conditions in healthy adult participants. * Part 2 will be a randomized, open-label, 2 × 4 crossover study (Periods 1, 2, 3, and 4) to evaluate the relative bioavailability (RBA) of Formulation A versus Formulation B under fasted conditions and explore safety, tolerability, and PK effects of food on Formulation A and Formulation B in healthy adult participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
Oral
Oral
PPD Phase 1 Clinic
Austin, Texas, United States
Pharmacokinetics- Cmax Part 1
Maximum plasma concentration of drug
Time frame: Up to 96 hours after dosing
Pharmacokinetics- Tmax Part 1
Time to maximum plasma concentration
Time frame: Up to 96 hours after dosing
Pharmacokinetics- AUC0-∞Part 1
Area under the plasma concentration-time curve from time zero to infinity
Time frame: Up to 96 hours after dosing
Pharmacokinetics- AUC0-t Part1
Area under the plasma concentration-time curve from time zero to the last observable concentration
Time frame: Up to 96 hours after dosing
Pharmacokinetics- t½ Part 1
Terminal elimination half-life
Time frame: Up to 96 hours after dosing
Pharmacokinetics- CL/F Part 1
Apparent total plasma clearance
Time frame: Up to 96 hours after dosing
Pharmacokinetics- Vz/F Part 1
Apparent volume of distribution
Time frame: Up to 96 hours after dosing
Pharmacokinetics- tlag Part 1
Lag time between time of administration and start of absorption
Time frame: Up to 96 hours after dosing
Pharmacokinetics- Cmax Part 2
Maximum plasma concentration of drug
Time frame: Up to 96 hours after dosing
Pharmacokinetics- Ratio of Cmax (Formulation A/Formulation B) Part 2
Ratio of maximum plasma concentration of drug
Time frame: Up to 96 hours after dosing
Pharmacokinetics- AUC0-∞ Part 2
Area under the plasma concentration-time curve from time zero to infinity
Time frame: Up to 96 hours after dosing
Pharmacokinetics- Ratio of AUC0-∞ (Formulation A/Formulation B) Part 2
Ratio of area under the plasma concentration-time curve from time zero to infinity
Time frame: Up to 96 hours after dosing
Pharmacokinetics- AUC0-t Part 2
Area under the plasma concentration-time curve from time zero to the last observable concentration
Time frame: Up to 96 hours after dosing
Pharmacokinetics- AUC0-t (Formulation A/Formulation B) Part 2
Area under the plasma concentration-time curve from time zero to the last observable concentration
Time frame: Up to 96 hours after dosing
Pharmacokinetics- Tmax Part 2
Time to maximum plasma concentration
Time frame: Up to 96 hours after dosing
Pharmacokinetics- t½ Part 2
Terminal elimination half-life
Time frame: Up to 96 hours after dosing
Pharmacokinetics- CL/F Part 2
Apparent total plasma clearance
Time frame: Up to 96 hours after dosing
Pharmacokinetics- Vz/F Part 2
Apparent volume of distribution
Time frame: Up to 96 hours after dosing
Pharmacokinetics- tlag Part 2
Lag time between time of administration and start of absorption
Time frame: Up to 96 hours after dosing
Pharmacokinetics- Cmax (high-fat meal)
Maximum plasma concentration of drug
Time frame: Up to 96 hours after dosing
Pharmacokinetics- Ratio (Fed/Fasted) of Cmax (high-fat meal)
Ratio of maximum plasma concentration of drug
Time frame: Up to 96 hours after dosing
Pharmacokinetics- AUC0-∞(high-fat meal)
Area under the plasma concentration-time curve from time zero to infinity
Time frame: Up to 96 hours after dosing
Pharmacokinetics- Ratio (Fed/Fasted) of AUC0-∞ (high-fat meal)
Ratio of area under the plasma concentration-time curve from time zero to infinity
Time frame: Up to 96 hours after dosing
Pharmacokinetics- AUC0-t (high-fat meal)
Area under the plasma concentration-time curve from time zero to the last observable concentration
Time frame: Up to 96 hours after dosing
Pharmacokinetics- Ratio (Fed/Fasted) of AUC0-t (high-fat meal)
Ratio of area under the plasma concentration-time curve from time zero to the last observable concentration
Time frame: Up to 96 hours after dosing
Pharmacokinetics- Tmax (high-fat meal)
Time to maximum plasma concentration
Time frame: Up to 96 hours after dosing
Pharmacokinetics- AUC0-24 (high-fat meal)
Area under the plasma concentration-time curve from time zero to 24 hours post dose
Time frame: Up to 96 hours after dosing
Pharmacokinetics- t½ (high-fat meal)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Terminal elimination half-life
Time frame: Up to 96 hours after dosing
Pharmacokinetics- CL/F (high-fat meal)
Apparent total plasma clearance
Time frame: Up to 96 hours after dosing
Pharmacokinetics- Vz/F (high-fat meal)
Apparent volume of distribution
Time frame: Up to 96 hours after dosing
Pharmacokinetics- tlag (high-fat meal)
Lag time between time of administration and start of absorption
Time frame: Up to 96 hours after dosing
Pharmacokinetics- Cmax (low-fat meal)
Maximum plasma concentration of drug
Time frame: Up to 96 hours after dosing
Pharmacokinetics- Ratio (Fed/Fasted) of Cmax (low-fat meal)
Ratio of maximum plasma concentration of drug
Time frame: Up to 96 hours after dosing
Pharmacokinetics- AUC0-∞(low-fat meal)
Area under the plasma concentration-time curve from time zero to infinity
Time frame: Up to 96 hours after dosing
Pharmacokinetics- Ratio (Fed/Fasted) of AUC0-∞(low-fat meal)
Ratio of area under the plasma concentration-time curve from time zero to infinity
Time frame: Up to 96 hours after dosing
Pharmacokinetics- AUC0-t (low-fat meal)
Area under the plasma concentration-time curve from time zero to the last observable concentration
Time frame: Up to 96 hours after dosing
Pharmacokinetics- Ratio (Fed/Fasted) of AUC0-t (low-fat meal)
Ratio of area under the plasma concentration-time curve from time zero to the last observable concentration
Time frame: Up to 96 hours after dosing
Pharmacokinetics- Tmax (low-fat meal)
Time to maximum plasma concentration
Time frame: Up to 96 hours after dosing
Pharmacokinetics- t½ (low-fat meal)
Terminal elimination half-life
Time frame: Up to 96 hours after dosing
Pharmacokinetics- CL/F (low-fat meal)
Apparent total plasma clearance
Time frame: Up to 96 hours after dosing
Pharmacokinetics- Vz/F (low-fat meal)
Apparent volume of distribution
Time frame: Up to 96 hours after dosing
Pharmacokinetics- tlag (low-fat meal)
Lag time between time of administration and start of absorption
Time frame: Up to 96 hours after dosing
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 (ie, 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 completion of study treatment