Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Richmond Pharmacology Limited | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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)
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects receiving treatment sequence ABC | Experimental | Subjects will receive treatment sequence ABC on Days 1, 3 and 5 respectively; A= 3x50 milligrams FOR-6219 soft gelatine capsule given in fasted state, B= 3x50 milligrams FOR-6219 tablet given in fed state, C= 3x50 milligrams FOR-6219 tablet given in fasted state. |
|
| Subjects receiving treatment sequence BCA | Experimental | Subjects will receive treatment sequence BCA on Days 1, 3 and 5 respectively; B= 3x50 milligrams FOR-6219 tablet given in fed state, C= 3x50 milligrams FOR-6219 tablet given in fasted state, A= 3x50 milligrams FOR-6219 soft gelatine capsule given in fasted state. |
|
| Subjects receiving treatment sequence CAB | Experimental | Subjects will receive treatment sequence CAB on Days 1, 3 and 5 respectively; C= 3x50 milligrams FOR-6219 tablet given in fasted state, A= 3x50 milligrams FOR-6219 soft gelatine capsule given in fasted state, B= 3x50 milligrams FOR-6219 tablet given in fed state. |
|
| Subjects receiving treatment sequence ACB | Experimental | Subjects will receive treatment sequence ACB on Days 1, 3 and 5 respectively; A= 3x50 milligrams FOR-6219 soft gelatine capsule given in fasted state, C= 3x50 milligrams FOR-6219 tablet given in fasted state, B= 3x50 milligrams FOR-6219 tablet given in fed state. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FOR-6219 capsule formulation | Drug | FOR-6219 capsule formulation will be available as a soft gelatine capsule with a single dose of 50 milligrams, administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of Peak Plasma Concentration (Cmax) after single dose of FOR-6219 tablet (fasted) over soft gelatine capsule (fasted) for FOR-6219. | 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. | 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. | 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. | Up to 48 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Peak plasma concentration (Cmax) | 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) | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Naturally (spontaneously) post-menopausal women or women with bilateral oophorectomy/bilateral salpingo-oophorectomy
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ulrike Lorch, M.D. | Richmond Pharmacology Limited | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Richmond Pharmacology Ltd. | London | United Kingdom |
Not provided
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Subjects receiving treatment sequence BAC | Experimental | Subjects will receive treatment sequence BAC on Days 1, 3 and 5 respectively; B= 3x50 milligrams FOR-6219 tablet given in fed state, A= 3x50 milligrams FOR-6219 soft gelatine capsule given in fasted state, C= 3x50 milligrams FOR-6219 tablet given in fasted state. |
|
| Subjects receiving treatment sequence CBA | Experimental | Subjects will receive treatment sequence CBA on Days 1, 3 and 5 respectively; C= 3x50 milligrams FOR-6219 tablet given in fasted state, B= 3x50 milligrams FOR-6219 tablet given in fed state, A= 3x50 milligrams FOR-6219 soft gelatine capsule given in fasted state. |
|
| FOR-6219 tablet formulation | Drug | FOR-6219 tablet formulation will be available as a tablet with a single dose of 50 milligrams, administered orally. |
|
| Terminal half-life (t½) | 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) | 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 total plasma clearance (CL/f) | 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) | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 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. | 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. | From Day -1 until 96 hours after the last FOR-6219 dose |
| D000091662 | Genital Diseases |