This study is an open label, Randomized, Three-period, Crossover Study to Compare the Pharmacokinetics of GB1211 upon Dosing a Capsule under Fasting Condition and a Tablet under Fasting and Fed Conditions in Healthy Volunteers
This is relative bioavailability and food effect study to enable further clinical development of a tablet formulation of GB1211.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
13
Hard tablet or capsules for oral use
QPS Netherlands BV
Groningen, Netherlands
To measure the maximum plasma concentration of GB1211 (Cmax)
Timepoints for PK sampling Period 1: Day 1: pre-dose and at hrs 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), and 96 (Day 5) post-dose. Period 2: Day 1: pre-dose and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), and 96 (Day 5) post-dose. Period 3: Day 1: pre-dose and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), and 96 (Day 5) post-dose.
Time frame: 5 weeks
To measure the time to reach Cmax GB1211 (Tmax)
Timepoints for PK sampling Period 1: Day 1: pre-dose and at hrs 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), and 96 (Day 5) post-dose. Period 2: Day 1: pre-dose and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), and 96 (Day 5) post-dose. Period 3: Day 1: pre-dose and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), and 96 (Day 5) post-dose.
Time frame: 5 weeks
To measure the area under the plasma concentration-time curve of GB1211 (AUC)
Timepoints for PK sampling for Period 1: Day 1: pre-dose and at hrs 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), and 96 (Day 5) post-dose. Period 2: Day 1: pre-dose and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), and 96 (Day 5) post-dose. Period 3: Day 1: pre-dose and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), and 96 (Day 5) post-dose.
Time frame: 5 weeks
To measure the amount of GB1211 excreted in urine (Ae)
Study Period 1: Pre-dose (single sample) and at \[0 to 6 h\], \[6 to 12 h\] (Day 1), \[12 to 24 h\] (Day 2), \[24 to 48 h\] (Day 3), \[48 to 72 h\] (Day 4), \[72 to 96 h\] (Day 5) post-dose.
Time frame: 5 days
To measure the fraction of GB1211 excreted in urine (Fe)
Study Period 1: Pre-dose (single sample) and at \[0 to 6 h\], \[6 to 12 h\] (Day 1), \[12 to 24 h\] (Day 2), \[24 to 48 h\] (Day 3), \[48 to 72 h\] (Day 4), \[72 to 96 h\] (Day 5) post-dose.
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Time frame: 5 days
To determine the number of participants with adverse events
Number of participants with adverse events graded as mild, moderate, or severe according to the study protocol. Number of participants with adverse events related and not related to the study drug.
Time frame: 5 weeks