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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05358756 | A Study of Bioavailability and Food Effect of SACT-1 and Edurant® Tablets in Healthy Adult Volunteers | PHASE1 | COMPLETED | 16 | — | — | Oct 9, 2021 | Dec 14, 2021 | May 26, 2022 | 1 | United States |
Compare the relative bioavailability of 150 mg SACT-1 (oral suspension) under fasted and fed conditions to 150 mg Edurant® (6 × 25 mg rilpivirine, oral tablets) under fed conditions.
| Arm | Type | Description |
|---|---|---|
| Treatment A :Fasted | EXPERIMENTAL | A single adminstration of SACT-1 (150 mg rilpivirine oral suspension) after a supervised overnight fast of at least 10 hours. |
| Treatment B: Fed | EXPERIMENTAL | A single adminstration of SACT-1 (150 mg rilpivirine oral suspension) after a supervised overnight fast of at least 10 hours followed by a high-fat, high calorie meal (fed).Subjects started the standardized high-fat, high-calorie breakfast 30 minutes prior to dosing and consumed this meal within the 30 minutes before dosing. |
| Treatment C: Fed | ACTIVE_COMPARATOR | Adminstartion of Edurant, 150 mg (6 × 25 mg rilpivirine, oral tablets), after a supervised overnight fast of at least 10 hours followed by a high-fat, high calorie meal (fed).Subjects started the standardized high-fat, high-calorie breakfast 30 minutes prior to dosing and consumed this meal within the 30 minutes before dosing. |
| Name | Type | Description |
|---|---|---|
| SACT-1 | DRUG | Single administartion of 150mg SACT-1 |
| EDURANT 25Mg Tablet | DRUG | Single administartion of six EDURANT 25mg tablets (Total 150mg) |
Inclusion Criteria: 1. Healthy male or female volunteers ≥ 18 years of age. 2. Males or non-pregnant, non-lactating females who are postmenopausal, naturally or surgically sterile (bilateral tubal ligation with surgery at least 6 weeks prior to study initiation or hysterectomy), or who agree to use...