A Phase 1 interventional study of pimicotinib capsules in Pharmacokinetics, sponsored by Abbisko Therapeutics Co, Ltd. Completed at 1 site in China. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-17.
Sponsored by Abbisko Therapeutics Co, Ltd · Phase 1, Interventional, and Other
This is a study to evaluate the relative bioavailability and tolerability of two different pimicotinib capsules in healthy subjects under fasting condition. 26 healthy subjects are planned to be enrolled and will be evenly randomized to either Study Sequence A or Study Sequence B . Subjects in Sequence A/Sequence B will receive a single 50 mg oral dose of test/reference pimicotinib in period 1 and cross over in period 2. Blood samples will be collected for PK analysis in totally 32 time-points.
Abbisko Therapeutics Co, Ltd is the lead sponsor of 36 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
subjects in sequence A will receive a single oral dose of 50 mg test capsule administered as 2 x 25 mg (the capsule is commercial formulation to be marketed) in period 1 day 1 and receive a single oral dose of 50 mg reference capsule administered as 2 x 25 mg (the capsule was used in phase 3 study Part 1) in period 2 day 1.
Drug: pimicotinib capsules
subjects in sequence B will receive a single oral dose of 50 mg reference capsule administered as 2 x 25 mg (the capsule was used in phase 3 study Part 1) in period 1 day 1 and receive a single oral dose of 50 mg test capsule administered as 2 x 25 mg (the capsule is commercial formulation to be marketed) in period 2 day 1 .
Drug: pimicotinib capsules
pimicotinib capsules
Cmax
Peak concentration, the maximum observed plasma concentration of pimicotinib
Time frame: Period 1& Period 2: pre-dose, postdose 15 minutes, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 24 hours, 48 hours, 96 hours, 120 hours, 144 hours, 192 hours and 240 hours.
AUC0-∞
Area under the plasma concentration-time curve of pimicotinib from time 0 to infinity, calculated as: AUC0-∞=AUClast +Clast/λz; Clast refers to the last measurable (non-BQL) plasma concentration of pimicotinib.
Time frame: Period 1& Period 2: pre-dose, postdose 15 minutes, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 24 hours, 48 hours, 96 hours, 120 hours, 144 hours, 192 hours and 240 hours.
AUClast
Area under the plasma concentration-time curve of pimicotinib from time 0 to the time of last measurable (non-BQL) concentration (calculated using the Linear Up Log Down trapezoidal method)
Time frame: Period 1& Period 2: pre-dose, postdose 15 minutes, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 24 hours, 48 hours, 96 hours, 120 hours, 144 hours, 192 hours and 240 hours.
AE
To evaluate the safety following a single oral dose of the two different pimicotinib capsules under fasting conditions in healthy subjects, including Adverse events (AEs), serious adverse events (SAEs), vital signs, physical examinations, electrocardiograms (ECGs), laboratory tests
Time frame: through study completion, an average of 24 days
t1/2
Elimination half-life
Time frame: Period 1& Period 2: pre-dose, postdose 15 minutes, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 24 hours, 48 hours, 96 hours, 120 hours, 144 hours, 192 hours and 240 hours.
CL/F
Total apparent clearance after a single oral dose
Time frame: Period 1& Period 2: pre-dose, postdose 15 minutes, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 24 hours, 48 hours, 96 hours, 120 hours, 144 hours, 192 hours and 240 hours.
Vz/F
Apparent volume of distribution after a single oral dose
Time frame: Period 1& Period 2: pre-dose, postdose 15 minutes, 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 24 hours, 48 hours, 96 hours, 120 hours, 144 hours, 192 hours and 240 hours.
Plan to share: No
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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Abbisko Therapeutics Co, Ltd