Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01416363 | Healthy Volunteer Study Using 3 Different Formulations of Firategrast | PHASE1 | COMPLETED | 38 | — | — | May 20, 2011 | Sep 17, 2011 | Jul 7, 2017 | 1 | Australia |
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...