Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SACT-1 · 1 trial · 1 indication
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...
SACT-1 is an investigational small molecule developed by Aptorum Group Limited. It has been studied in a Phase 1 clinical trial in healthy adult volunteers, and no specific disease indication has been disclosed for the program.
SACT-1 is being developed by Aptorum Group Limited, which trades on the Nasdaq under the ticker APM. The company sponsored the Phase 1 study of the compound conducted in the United States.
SACT-1 has completed a Phase 1 clinical trial. It is an investigational drug and is not approved by the FDA. The completed study was a bioavailability and food effect trial conducted in healthy adult volunteers.
SACT-1 has been evaluated in one clinical trial, NCT05358756, titled A Study of Bioavailability and Food Effect of SACT-1 and Edurant Tablets in Healthy Adult Volunteers. The Phase 1 trial enrolled 16 participants in the United States and is completed.
The Phase 1 trial NCT05358756 was an active-controlled, randomized study that enrolled 16 healthy adult volunteers aged 18 years and older in the United States. It assessed bioavailability and food effect and has been completed.