This is a phase 1, randomised, open-label, three-way, three-period, crossover relative bioavailability study to assess the single-dose pharmacokinetics of FOR-6219 in capsule and tablet formulations in postmenopausal women. The effect of high-fat food on the pharmacokinetics of the tablet formulation will also be evaluated. A total of twelve, post-menopausal women, will be randomised to receive a single oral dose of FOR-6219 in three treatment periods: capsule formulation (fasted); tablet formulation (fed); tablet formulation (fasted)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
12
FOR-6219 capsule formulation will be available as a soft gelatine capsule with a single dose of 50 milligrams, administered orally.
FOR-6219 tablet formulation will be available as a tablet with a single dose of 50 milligrams, administered orally.
Richmond Pharmacology Ltd.
London, United Kingdom
Ratio of Peak Plasma Concentration (Cmax) after single dose of FOR-6219 tablet (fasted) over soft gelatine capsule (fasted) for FOR-6219.
Time frame: Up to 48 hours postdose
Ratio of Area under the plasma concentration versus time curve (AUC) after single dose of FOR-6219 tablet (fasted) over soft gelatine capsule (fasted) for FOR-6219.
Time frame: Up to 48 hours postdose
Ratio of Peak Plasma Concentration (Cmax) after single dose of FOR-6219 tablet (fed) over tablet (fasted) for FOR-6219.
Time frame: Up to 48 hours postdose
Ratio of Area under the plasma concentration versus time curve (AUC) after single dose of FOR-6219 tablet (fed) over tablet (fasted) for FOR-6219.
Time frame: Up to 48 hours postdose
Peak plasma concentration (Cmax)
Time frame: Blood sampling up to the end of each treatment period: Up to 48 hours after the FOR-6219 dose in Period 1 and Period 2 and up to 96 hours after the FOR-6219 dose in Period 3
Time to peak plasma concentration (Tmax)
Time frame: Blood sampling up to the end of each treatment period: Up to 48 hours after the FOR-6219 dose in Period 1 and Period 2 and up to 96 hours after the FOR-6219 dose in Period 3
Terminal half-life (t½)
Time frame: Blood sampling up to the end of each treatment period: Up to 48 hours after the FOR-6219 dose in Period 1 and Period 2 and up to 96 hours after the FOR-6219 dose in Period 3
Area under the plasma concentration versus time curve (AUC)
Time frame: Blood sampling up to the end of each treatment period: Up to 48 hours after the FOR-6219 dose in Period 1 and Period 2 and up to 96 hours after the FOR-6219 dose in Period 3
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Apparent total plasma clearance (CL/f)
Time frame: Blood sampling up to the end of each treatment period: Up to 48 hours after the FOR-6219 dose in Period 1 and Period 2 and up to 96 hours after the FOR-6219 dose in Period 3
Apparent volume of distribution during terminal phase (Vz/f)
Time frame: Blood sampling up to the end of each treatment period: Up to 48 hours after the FOR-6219 dose in Period 1 and Period 2 and up to 96 hours after the FOR-6219 dose in Period 3
Incidence of Treatment Emergent Adverse Events (TEAE)
Time frame: Adverse Events will be monitored from screening to 96 hours after the last FOR-6219 dose
Proportion of participants with morphological or rhythm abnormalities on Electrocardiograms (ECGs)
12-lead ECGs will be used to measure ECG
Time frame: From Day -1 until 96 hours after the last FOR-6219 dose
Proportion of participants with clinically significant changes in Electrocardiogram (ECG) PR time interval
12-lead ECGs will be used to measure ECG
Time frame: From Day -1 until 96 hours after the last FOR-6219 dose
Proportion of participants with clinically significant changes in Electrocardiogram (ECG) QRS time interval
12-lead ECGs will be used to measure ECG
Time frame: From Day -1 until 96 hours after the last FOR-6219 dose
Proportion of participants with clinically significant changes in Electrocardiogram (ECG) QT time interval
12-lead ECGs will be used to measure ECG
Time frame: From Day -1 until 96 hours after the last FOR-6219 dose
Proportion of participants with clinically significant changes in Electrocardiogram (ECG) QTc interval
12-lead ECGs will be used to measure ECG
Time frame: From Day -1 until 96 hours after the last FOR-6219 dose
Proportion of participants with clinically significant changes in laboratory safety tests
Laboratory safety tests include haematology, chemistry, coagulation and urinalysis
Time frame: From Day -1 until 96 hours after the last FOR-6219 dose
Proportion of participants with clinically significant changes in systolic blood pressure
Blood pressure will be measured using automated monitors in supine position after 5 minute rest.
Time frame: From Day -1 until 96 hours after the last FOR-6219 dose
Proportion of participants with clinically significant changes in diastolic blood pressure
Blood pressure will be measured using automated monitors in supine position after 5 minute rest.
Time frame: From Day -1 until 96 hours after the last FOR-6219 dose
Proportion of participants with clinically significant changes in pulse rate
Pulse rate will be measured using automated monitors in supine position after 5 minute rest.
Time frame: From Day -1 until 96 hours after the last FOR-6219 dose