The purpose of this study is to compare the single-dose pharmacokinetics (PK) of two formulations (Formulation 1 and Formulation 2) of AG-881 and to examine the effect of food and multiple-dose omeprazole on the single-dose PK of AG-881 Formulation 2 in healthy adult participants. This study will also assess the safety and tolerability of single-dose AG-881 (Formulation 1 and 2) alone and of AG-881 Formulation 2 when administered with and without food and when coadministered with omeprazole in healthy adult subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
AG881 uncoated tablets
AG881 film-coated tablets
Omeprazole capsules
Celerion
Tempe, Arizona, United States
Area Under the Concentration-Time Curve From Time 0 to the Last Observed Non-Zero Concentration (AUC0-t) of AG-881 Formulation 1 without Food
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Area Under the Concentration-Time Curve From Time 0 to the Last Observed Non-Zero Concentration (AUC0-t) of AG-881 Formulation 2 with Food, without Food and when Co-administered with Omeprazole
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of AG-881 Formulation 1 without Food
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Area Under the Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of AG-881 Formulation 2 with Food, without Food and when Co-administered with Omeprazole
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Maximum Observed Concentration (Cmax) of AG-881 Formulation 1 without Food
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Maximum Observed Concentration (Cmax) of AG-881 Formulation 2 with Food, without Food and when Co-administered with Omeprazole
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Area Under the Concentration-Time Curve, From Time 0 to 504 Hours Postdose (AUC0-504) of AG-881 Formulation 1 without Food
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Area Under the Concentration-Time Curve, From Time 0 to 504 Hours Postdose (AUC0-504) of AG-881 Formulation 2 with Food, without Food and when Co-administered with Omeprazole
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Apparent Total Plasma Clearance After Oral (Extravascular) Administration (CL/F) of AG-881 Formulation 1 without Food
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Apparent Total Plasma Clearance After Oral (Extravascular) Administration (CL/F) of AG-881 Formulation 2 with Food, without Food and when Co-administered with Omeprazole
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Apparent Terminal Elimination Half-life (t½) of AG-881 Formulation 1 without Food
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Apparent Terminal Elimination Half-life (t½) of AG-881 Formulation 2 with Food, without Food and when Co-administered with Omeprazole
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Time Delay Between Drug Administration and the Onset of Absorption (tlag) of AG-881 Formulation 1 without Food
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Time Delay Between Drug Administration and the Onset of Absorption (tlag) of AG-881 Formulation 2 with Food, without Food and when Co-administered with Omeprazole
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Time to Reach Maximum Observed Concentration (Tmax) of AG-881 Formulation 1 without Food
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Time to Reach Maximum Observed Concentration (Tmax) of AG-881 Formulation 2 with Food, without Food and when Co-administered with Omeprazole
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Apparent Volume of Distribution After Oral (Extravascular) Administration (Vd/F) of AG-881 Formulation 1 without Food
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Apparent Volume of Distribution After Oral (Extravascular) Administration (Vd/F) of AG-881 Formulation 2 with Food, without Food and when Co-administered with Omeprazole
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Number of Participants with Abnormalities in Triplicate 12-lead Electrocardiograms (ECGs)
Time frame: Up to 21 days in Period 1, 2, 3 (Each period is 21 days); up to 25 days in Period 4 (Period 4 is 25 days)
Number of Participants with Abnormalities in Vital Sign Measurements
Vital sign measurements will include body temperature, respiratory rate, blood pressure, and heart rate.
Time frame: Up to 21 days in Period 1, 2, 3 (Each period is 21 days); up to 25 days in Period 4 (Period 4 is 25 days)
Columbia-suicide Severity Rating Scale (C-SSRS) Score
The C-SSRS is a questionnaire scale to detect emergent suicide symptoms (suicidal ideation or actual suicidal behavior) during the course of this study. Questions are either answered yes/no or are on a scale of 1 (low severity) to 5 (high severity).
Time frame: Up to 21 days in Period 1, 2, 3 (Each period is 21 days); up to 25 days in Period 4 (Period 4 is 25 days)
Number of Participants with Abnormalities in Clinical Laboratory Tests
Clinical laboratory assessments will include hematology, serum chemistry, coagulation, and urinalysis.
Time frame: Up to 21 days in Period 1, 2, 3 (Each period is 21 days); up to 25 days in Period 4 (Period 4 is 25 days)
Number of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence associated with the use of a drug, whether or not considered drug-related.
Time frame: Up to 28 Days After Last Dose of Study Drug (Up to 91 days)'
Number of Participants with Abnormalities in Physical Examinations
Physical examination will include, examination of skin, neurological, respiratory, cardiovascular, and gastrointestinal systems.
Time frame: Up to 21 days in Period 1, 2, 3 (Each period is 21 days); up to 25 days in Period 4 (Period 4 is 25 days)
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