Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Firategrast immediate release · 1 trial · 1 indication
Cmax of firategrast
AUC(0-t) of firategrast
AUC(0-24) of firategrast
| Arm | Type | Description |
|---|---|---|
| Treatment Arm ACB: Part 1 | EXPERIMENTAL | Subjects will receive treatment sequence ACB; A : Firategrast immediate release tablet 1200 milligram (mg) once only orally, C : Firategrast simulated gastro-retentive solution 1200 mg once only by naso-gastric route, B : Firategrast 3 hour release tablet 1200 mg once only orally. There will be a washout period of 5 days between doses. |
| Treatment Arm BAC: Part 1 | EXPERIMENTAL | Subjects will receive treatment sequence BAC; B : Firategrast 3 hour release tablet 1200 mg once only orally, A : Firategrast immediate release tablet 1200 mg once only orally, C : Firategrast simulated gastro-retentive solution 1200 mg once only by naso-gastric route. There will be a washout period of 5 days between doses. |
| Treatment Arm CBA: Part 1 | EXPERIMENTAL | Subjects will receive treatment sequence CBA; C : Firategrast simulated gastro-retentive solution 1200 mg once only by naso-gastric route, B : Firategrast 3 hour release tablet 1200 mg once only orally, A : Firategrast immediate release tablet 1200 mg once only orally. There will be a washout period of 5 days between doses. |
| Treatment Arm BCA: Part 1 | EXPERIMENTAL | Subjects will receive treatment sequence BCA; B : Firategrast 3 hour release tablet 1200 mg once only orally, C : Firategrast simulated gastro-retentive solution 1200 mg once only by naso-gastric route, A : Firategrast immediate release tablet 1200 mg once only orally. There will be a washout period of 5 days between doses. |
| Treatment Arm CAB: Part 1 | EXPERIMENTAL | Subjects will receive treatment sequence CAB; C : Firategrast simulated gastro-retentive solution 1200 mg once only by naso-gastric route, A : Firategrast immediate release tablet 1200 mg once only orally, B : Firategrast 3 hour release tablet 1200 mg once only orally. There will be a washout period of 5 days between doses. |
| Treatment Arm ABC: Part 1 | EXPERIMENTAL | Subjects will receive treatment sequence ABC; A : Firategrast immediate release tablet 1200 mg once only orally, B : Firategrast 3 hour release tablet 1200 mg once only orally, C : Firategrast simulated gastro-retentive solution 1200 mg once only by naso-gastric route. There will be a washout period of 5 days between doses. |
| Treatment Arm D: Part 2 | EXPERIMENTAL | Subject will receive D: Firategrast immediate release tablet 600 mg twice daily for 7 days |
| Treatment Arm E: Part 2 | EXPERIMENTAL | Subject will receive E: Firategrast 3 hour release tablet 1200 mg twice daily for 7 days |
| Treatment Arm F: Part 2 | EXPERIMENTAL | Subject will receive F: Firategrast simulated gastro-retentive solution 1200 mg twice daily for 7 days |
| Name | Type | Description |
|---|---|---|
| Firategrast immediate release tablet | DRUG | Firategrast immediate release tablet is white to pale cream colored 300 mg unit dose and subjects will administer it with 240 milliliter (mL) of water. |
| Firategrast modified release tablet | DRUG | Firategrast modified release tablet is white to slightly colored 600 mg unit dose and subjects will administer it with 240 mL of water. |
| Firategrast gastro-retentive solution | DRUG | Firategrast solution is clear colorless solution and subject will administer it via nasogastric route. |
Inclusion Criteria: * Male aged 18 to 65 yrs inclusive * Healthy, as determined by study physician * Capable of giving iformed consent Exclusion Criteria: * Positive drugs of abuse result * Positive for HIV or Hepatitis B and/or C viruses * History of alcohol consumption in excess of average reco...
Firategrast immediate release is an investigational small molecule being studied for the treatment of relapsing-remitting multiple sclerosis. It is currently in Phase 1 clinical development. The drug is not approved and remains under investigation for this neurological condition.
Firategrast immediate release is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and tolerability in healthy volunteers.
Firategrast immediate release is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. One Phase 1 trial has been completed, involving 38 participants, to assess different formulations of the drug.
Firategrast immediate release has one completed clinical trial registered as NCT01416363, titled 'Healthy Volunteer Study Using 3 Different Formulations of Firategrast.' This Phase 1 study enrolled 38 healthy male volunteers in Australia and evaluated the drug's safety and tolerability.
Firategrast immediate release is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for relapsing-remitting multiple sclerosis. The drug has not completed the clinical trials necessary to establish safety and efficacy for regulatory approval.