This clinical trial is a study to evaluate the pharmacokinetics of the tablet formulation Pociredir in fasted and fed state participants with Sickle Cell Disease (SCD).
The study is designed to assess the pharmacokinetics of the tablet formulation of pociredir under fasted conditions in up to approximately 12 study participants with SCD (Fasted Cohort). An additional cohort of up to approximately 12 study participants with SCD may be enrolled to evaluate the potential effect of food on the PK of the tablet formulation (Fed Cohort). The fasted cohort will be conducted first. The study will include screening period: Day -28 to Day -2; In-patient confinement period: Days -1 to 3; check-in on day -1; single dose of pociredir on day 1; discharge on Day 3; outpatient visit: Day 4; end of study (EOS) visit: Days 8-11 Eligible participants who meet all inclusion and none of the exclusion criteria will be admitted to the clinical site on Day -1, the day before dosing. Participants may be discharged on Day 3 following completion of 48-hour PK sampling or may remain in-clinic through Day 4 if needed. Fasted Cohort: Participants will fast for at least 10 hours prior to dosing and remain fasted for 4 hours post-dose. Water intake will be restricted for 1 hour before and after administration of the investigational medicinal product (IMP). Fed Cohort (if conducted): Participants will fast for at least 10 hours prior to breakfast and will receive a standard high-fat breakfast starting 30 minutes before dosing. Pharmacokinetic samples will be collected up to 72 hours post-dose. Participants are required to remain in-clinic for the first 48 hours post-dose and may return to the site for subsequent Outpatient and EOS visits.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Pociredir tablet formulation
Advanced Pharma - Miami
Miami, Florida, United States
RECRUITINGOmega Research Group
Orlando, Florida, United States
RECRUITINGSonar Clinical Research
Riverdale, Georgia, United States
Plasma concentration of pociredir under fasted and fed conditions
Time frame: Day 1 through Day 4
Maximum plasma concentration (Cmax) of pociredir under fasted and fed conditions
Time frame: Day 1 through Day 4
Area under the plasma concentration-time curve from time 0 to 24 hours (AUC(0-24)) of pociredir under fasted and fed conditions
Time frame: Day 1 through Day 4
Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUC(0-tlast)) of pociredir under fasted and fed conditions
Time frame: Day 1 through Day 4
Area under the plasma concentration-time curve from time 0, extrapolated to infinity (AUC(0-inf)), of pociredir under fasted and fed conditions
Time frame: Day 1 through Day 4
Time to maximum plasma concentration (Tmax) of pociredir under fasted and fed conditions
Time frame: Day 1 through Day 4
Terminal disposition rate constant (λz) of pociredir under fasted and fed conditions
Time frame: Day 1 through Day 4
Terminal half-life (t1/2) of pociredir under fasted and fed conditions
Time frame: Day 1 through Day 4
Apparent volume of distribution during the terminal phase (Vz/F) of pociredir under fasted and fed conditions
Time frame: Day 1 through Day 4
Apparent clearance (CL/F) of pociredir under fasted and fed conditions
Time frame: Day 1 through Day 4
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Neuro-Behavioral Clinical Research
North Canton, Ohio, United States
RECRUITINGUniversity of Texas Health Science Center Houston
Houston, Texas, United States
NOT_YET_RECRUITINGWorldwide Clinical Trials
San Antonio, Texas, United States
RECRUITINGNumber of participants with treatment emergent adverse events (TEAEs) under fasted and fed conditions
Time frame: Up to Day 11
Number of participants with clinically significant changes in safety assessments under fasted and fed conditions
Time frame: Up to Day 11
Number of participants with clinically significant findings in clinical laboratory evaluations, vital signs, electrocardiogram (ECGs) and physical examination
Time frame: Up to Day 11
Plasma concentration of pociredir under fasted and fed conditions compared to healthy participants
Time frame: Day 1 through Day 4
Cmax of pociredir under fasted and fed conditions compared to healthy participants
Time frame: Day 1 through Day 4
AUC(0-24) of pociredir under fasted and fed conditions compared to healthy participants
Time frame: Day 1 through Day 4
AUC(0-tlast) of pociredir under fasted and fed conditions compared to healthy participants
Time frame: Day 1 through Day 4
AUC(0-inf), under fasted and fed conditions compared to healthy participants
Time frame: Day 1 through Day 4
Tmax of pociredir under fasted and fed conditions compared to healthy participants
Time frame: Day 1 through Day 4
λz of pociredir under fasted and fed conditions compared to healthy participants
Time frame: Day 1 through Day 4
t1/2 of pociredir under fasted and fed conditions compared to healthy participants
Time frame: Day 1 through Day 4
Vz/F of pociredir under fasted and fed conditions compared to healthy participants
Time frame: Day 1 through Day 4
CL/F of pociredir under fasted and fed conditions compared to healthy participants
Time frame: Day 1 through Day 4