The purpose of this study is to evaluate the relative bioavailability of a single 300 mg dose of GBT440 administered as a high strength (1 × 300 mg) capsule versus a low strength (3 × 100 mg) capsule formulation in healthy fasted subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Test: GBT440 300 mg capsule (high-strength) Reference: GBT440 100 mg capsule (low-strength)
ICON Early Phase Services, LLC Clinical Research Unit
San Antonio, Texas, United States
Pharmacokinetics (PK): Maximum observed concentration (Cmax) of GBT440 in whole blood
Time frame: predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose, and Day 12, Day 20, and Day 28 for each period
Pharmacokinetics (PK): Area under the concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUCt) of GBT440 in whole blood
Time frame: predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose, and Day 12, Day 20, and Day 28 for each period
Pharmacokinetics (PK): AUC from time 0 extrapolated to infinity (AUCinf) of GBT440 in whole blood
Time frame: predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose, and Day 12, Day 20, and Day 28 for each period
Pharmacokinetics (PK): The time that Cmax was observed (tmax) of GBT440 in whole blood
Time frame: predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose, and Day 12, Day 20, and Day 28 for each period
Pharmacokinetics (PK): Terminal elimination half-life (t½) of GBT440 in whole blood
Time frame: predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose, and Day 12, Day 20, and Day 28 for each period
Pharmacokinetics (PK): Apparent oral clearance (CL/F) of GBT440 in whole blood
Time frame: predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose, and Day 12, Day 20, and Day 28 for each period
Pharmacokinetics (PK): Apparent volume of distribution during the terminal phase (Vz/F) of GBT440 in whole blood
Time frame: predose, 1, 2, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours postdose, and Day 12, Day 20, and Day 28 for each period
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