This study will explore the potential effects of high-fat meal on the plasma pharmacokinetics (PK) of CRS3123 when administered as a single oral dose of 200 mg in healthy adult participants.
This study will assess the impact of a high-calorie and high-fat meal on the plasma pharmacokinetics (PK) of CRS3123 in healthy adult participants when administered as a single oral capsule of 200 mg dose. Pharmacokinetics (PK) of a single dose of CRS3123 200 mg will be studied following administration to healthy participants under fed and fasted conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
17
CRS3123 200 mg capsule given as a single oral dose
Syneos Health Miami
Miami, Florida, United States
Assessment of Food Effect Based on CRS3123 PK Parameters AUC0-t, AUC0-inf, and Cmax
CRS3123 PK parameters (AUC0-t, AUC0-inf, Cmax) values plotted against food status. Note: no food-effect is assumed if the 90% CI for the ratio of geometric means (B (fed)/A (fasted), based on least-squares means from the ANOVA of the ln-transformed CRS3123 AUC0-inf (or AUC0-t) AND Cmax, is within 80.00% to 125.00% for CRS3123.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6
Calculation of AUC0-t for CRS3123 Under Fasted vs Fed Conditions
Area under the concentration-time curve from time zero until the last observed concentration under fasted vs fed conditions
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6
Calculation of AUC0-inf for CRS3123 Under Fasted vs Fed Conditions.
Area under the concentration-time curve from time zero to infinity (extrapolated) under fasted vs fed conditions.
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6
Calculation of Cmax for CRS3123 Under Fasted vs Fed Conditions
Maximal observed concentration under fasted vs fed conditions
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6
Calculation of Tmax for CRS3123 Under Fasted vs Fed Conditions
Time when the maximal concentration is observed under fasted vs fed conditions
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6
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Calculation of Tlag for CRS3123 Under Fasted vs Fed Conditions
Time of observation prior to the first observation with a measurable (non-zero) concentration under fasted vs fed conditions
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6
Calculation of t1/2 for CRS3123 Under Fasted vs Fed Conditions
Terminal elimination half-life under fasted vs fed conditions
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6
Calculation of Kel for CRS3123 Under Fasted vs Fed Conditions
Terminal elimination rate constant under fasted vs fed conditions
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6
Calculation of Cl/F for CRS3123 Under Fasted vs Fed Conditions
Apparent clearance under fasted vs fed conditions
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6
Calculation of Vz/F for CRS3123 Under Fasted vs Fed Conditions
Apparent volume of distribution under fasted vs fed conditions
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6
Calculation of Tmax for CRS3123-glu3 Metabolite Under Fasted vs Fed Conditions
Time when the maximal concentration is observed under fasted vs fed conditions
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6
Calculation of Tlag for CRS3123-glu3 Metabolite Under Fasted vs Fed Conditions
Time of observation prior to the first observation with a measurable (non-zero) concentration under fasted vs fed conditions
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6
Calculation of t1/2 for CRS3123-glu3 Metabolite Under Fasted vs Fed Conditions
Terminal elimination half-life under fasted vs fed conditions
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6
Calculation of Kel for CRS3123-glu3 Metabolite Under Fasted vs Fed Conditions
Terminal elimination rate constant under fasted vs fed conditions
Time frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 16, and 24 hours post-dose on Day 1 and Day 6