To evaluate the safety, tolerability, and pharmacokinetics of pomalidomide administered orally once a day for 5 days, at daily doses of 0.5 mg, 1 mg, or 2 mg.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
33
0.5-mg, 1-mg, or 2-mg capsule administered once daily for 5 days under fasted conditions
Placebo capsule
PPD Phase I Clinic
Austin, Texas, United States
Number of participants with adverse events
Number of participants with adverse events
Time frame: 28 days after last dose
area under the plasma concentration-time curve
area under the plasma concentration-time curve
Time frame: 72 hours after last dose
time to maximum observed plasma concentration
time to maximum observed plasma concentration
Time frame: 72 hours after last dose
maximum observed plasma concentration
maximum observed plasma concentration
Time frame: 72 hours after last dose
terminal elimination half-life
terminal elimination half-life
Time frame: 72 hours after last dose
apparent total plasma clearance
apparent total plasma clearance
Time frame: 72 hours after last dose
apparent total volume of distribution, and accumulation ratio
apparent total volume of distribution, and accumulation ratio
Time frame: 72 hours after last dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.