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Also known as Firategrast immediate release tablet
Firategrast immediate release · 1 trial · 1 indication
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| 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 relapsing-remitting multiple sclerosis, a form of MS characterized by episodes of new or worsening symptoms. It is in Phase 1 clinical development and has not been approved for any indication. The immediate release designation refers to a tablet formulation designed to release the drug rapidly after administration.
Firategrast immediate release targets the integrin proteins ITGB1, ITGA4, and ITGB7, acting as an antagonist that blocks their activity. These integrins are involved in immune cell adhesion and migration, processes relevant to inflammatory conditions such as multiple sclerosis. By antagonizing these targets, the drug is designed to interfere with immune cell trafficking.
Firategrast immediate release is being developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program evaluating this formulation. The drug is an investigational asset within GSK's neurology pipeline, specifically for relapsing-remitting multiple sclerosis.
Firategrast immediate release is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any regulatory agency. The Phase 1 program has completed one trial, and no active trials are currently listed for this formulation.
Firategrast immediate release has been evaluated in one completed Phase 1 trial, NCT01416363, titled Healthy Volunteer Study Using 3 Different Formulations of Firategrast. The trial enrolled 38 healthy male volunteers in Australia, was randomized and controlled, and studied three different formulations of firategrast.
Yes, Firategrast immediate release and Firategrast immediate release tablet refer to the same investigational product. The tablet is the immediate release oral formulation developed by GSK. Both names describe the same small molecule integrin antagonist being studied in relapsing-remitting multiple sclerosis.