The main purpose of this study is to examine the effect of multiple doses of AG-881 on the pharmacokinetics (PK) of a single dose of lamotrigine in healthy adults.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
22
Supplied as uncoated tablets.
Supplied as tablets of LAMICTAL® or generic equivalent.
Celerion, Inc
Tempe, Arizona, United States
Area under the Concentration-time Curve from Time 0 to Infinity (AUC0-inf) for Lamotrigine Administered with Interacting Drug AG-881
Time frame: At multiple time points daily from Day 14 to Day 21 (or early discontinuation) in Period 2 (21-day period)
Area under the Concentration-time Curve from Time 0 to Infinity (AUC0-inf) for Lamotrigine Administered without Interacting Drug AG-881
Time frame: At multiple time points daily from Day 1 to Day 8 in Period 1 (8-day period)
Maximum Observed Plasma Concentration (Cmax) for Lamotrigine Administered with Interacting Drug AG-881
Time frame: At multiple time points daily from Day 14 to Day 21 (or early discontinuation) in Period 2 (21-day period)
Maximum Observed Plasma Concentration (Cmax) for Lamotrigine Administered without Interacting Drug AG-881
Time frame: At multiple time points daily from Day 1 to Day 8 in Period 1 (8-day period)
Area under the Concentration-time Curve, from Time 0 to the Last Observed Non-zero Concentration (t) (AUC0-t) for Lamotrigine Administered with Interacting Drug AG-881
Time frame: At multiple time points daily from Day 14 to Day 21 (or early discontinuation) in Period 2 (21-day period)
Area under the Concentration-time Curve, from Time 0 to the Last Observed Non-zero Concentration (t) (AUC0-t) for Lamotrigine Administered without Interacting Drug AG-881
Time frame: At multiple time points daily from Day 1 to Day 8 in Period 1 (8-day period)
Percent of AUC0-inf Extrapolated (AUC%extrap) for Lamotrigine Administered with Interacting Drug AG-881
Time frame: At multiple time points daily from Day 14 to Day 21 (or early discontinuation) in Period 2 (21-day period)
Percent of AUC0-inf Extrapolated (AUC%extrap) for Lamotrigine Administered without Interacting Drug AG-881
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Time frame: At multiple time points daily from Day 1 to Day 8 in Period 1 (8-day period)
Time to Maximum Observed Plasma Concentration (Tmax) for Lamotrigine Administered with Interacting Drug AG-881
Time frame: At multiple time points daily from Day 14 to Day 21 (or early discontinuation) in Period 2 (21-day period)
Time to Maximum Observed Plasma Concentration (Tmax) for Lamotrigine Administered without Interacting Drug AG-881
Time frame: At multiple time points daily from Day 1 to Day 8 in Period 1 (8-day period)
Apparent Terminal Elimination Rate Constant (Kel) for Lamotrigine Administered with Interacting Drug AG-881
Time frame: At multiple time points daily from Day 14 to Day 21 (or early discontinuation) in Period 2 (21-day period)
Apparent Terminal Elimination Rate Constant (Kel) for Lamotrigine Administered without Interacting Drug AG-881
Time frame: At multiple time points daily from Day 1 to Day 8 in Period 1 (8-day period)
Apparent Terminal Elimination Half-life (t½) for Lamotrigine Administered with Interacting Drug AG-881
Time frame: At multiple time points daily from Day 14 to Day 21 (or early discontinuation) in Period 2 (21-day period)
Apparent Terminal Elimination Half-life (t½) for Lamotrigine Administered without Interacting Drug AG-881
Time frame: At multiple time points daily from Day 1 to Day 8 in Period 1 (8-day period)
Apparent Total Plasma Clearance after Oral (Extravascular) Administration (CL/F) for Lamotrigine Administered with Interacting Drug AG-881
Time frame: At multiple time points daily from Day 14 to Day 21 (or early discontinuation) in Period 2 (21-day period)
Apparent Total Plasma Clearance after Oral (Extravascular) Administration (CL/F) for Lamotrigine Administered without Interacting Drug AG-881
Time frame: At multiple time points daily from Day 1 to Day 8 in Period 1 (8-day period)
Apparent Volume of Distribution during the Terminal Elimination Phase after Oral (Extravascular) Administration (Vz/F) for Lamotrigine Administered with Interacting Drug AG-881
Time frame: At multiple time points daily from Day 14 to Day 21 (or early discontinuation) in Period 2 (21-day period)
Apparent Volume of Distribution during the Terminal Elimination Phase after Oral (Extravascular) Administration (Vz/F) for Lamotrigine Administered without Interacting Drug AG-881
Time frame: At multiple time points daily from Day 1 to Day 8 in Period 1 (8-day period)
Percentage 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 approximately 4 weeks
Columbia-suicide Severity Rating Scale (C-SSRS)
The C-SSRS is a questionnaire scale to detect emergent suicide symptoms (suicidal ideation or actual suicidal behavior). Questions are either answered yes/no or are on a scale of 1 (low severity) to 5 (high severity).
Time frame: Up to approximately 4 weeks
Percentage of Participants with Abnormalities in 12-lead Electrocardiograms (ECGs)
Time frame: Up to approximately 4 weeks
Percentage of Participants with Abnormalities in Vital Sign Measurements
Vital signs will include body temperature, respiratory rate, blood pressure, and heart rate.
Time frame: Up to approximately 4 weeks
Percentage of Participants with Abnormalities in Clinical Laboratory Tests
Clinical laboratory assessments will include hematology, serum chemistry, coagulation, and urinalysis.
Time frame: Up to approximately 4 weeks
Percentage of Participants with Abnormalities in Physical Examinations
Time frame: Up to approximately 4 weeks