Covance Clinical Research unit
Evansville, Indiana, 47710, United States
NCT Number: NCT02433457
To evaluate the PK profile of the newly developed CC-292 SDD formulation compared to CC-292 P22 tablet.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 1
Evansville, Indiana, 47710, United States
This is a single center, open-label, randomized, seven-treatment, seven-period, crossover design. The study will consist of a screening phase, a treatment phase, and a follow-up phone call. Approximately 24 healthy adult subjects (male or female) will be enrolled.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Note: All other females must have been surgically sterilized for at least 6 months before Screening (proper documentation required), or be postmenopausal (defined as 24 months without menses before Screening, and an estradiol level of < 30 pg/mL and a plasma Follicle Stimulating Hormone (FSH) level > 40 IU/L at Screening).
Exclusion criteria
Time frame: 48 hours
Maximum observed concentration in plasma
Time frame: 48 hours
Area under the plasma concentration-time curve from time zero to the last measured time point
Time frame: 48 hours
Area under the plasma concentration-time curve to 24 hours post dose
Time frame: 48 hours
Area under the plasma concentration-time curve from time zero extrapolated to infinity
Time frame: 48 hours
Percent Area under the plasma concentration-time curve extrapolated
Time frame: 48 hours
Relative bioavailability of the CC-292 SDD formulation compared to the reference P22 formulation
Time frame: 48 hours
Time to Cmax
Time frame: 48 hours
Terminal disposition rate constant
Time frame: 48 hours
Terminal half-life
Time frame: 48 hours
Apparent clearance
Time frame: 48 hours
Apparent volume of distribution
Time frame: Approximatly 52 days
Number of subjects with adverse events
Celgene
Industry
An Open-label, Phase 1, Randomized, Seven-treatment, Seven-period, Crossover Study to Assess the Relative Bioavailability, pH Effect, Food Effect and Dose Proportionality of CC-292 Spray Dried Dispersion Formulation in Healthy Volunteers
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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