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 being studied in healthy subjects. It is currently in Phase 1 clinical development, with a completed trial evaluating its bioavailability and food effect in healthy adult volunteers. SACT-1 has been granted orphan drug designation by the FDA.
SACT-1 is being developed by Aptorum Group Limited, a biopharmaceutical company traded on the stock exchange under the ticker symbol APM. The company is conducting clinical trials to evaluate the drug's properties in healthy volunteers.
SACT-1 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical testing. The Phase 1 trial has been completed, and the drug remains in early-stage development.
SACT-1 has one completed Phase 1 clinical trial registered under NCT05358756. The study, titled "A Study of Bioavailability and Food Effect of SACT-1 and Edurant® Tablets in Healthy Adult Volunteers," enrolled 16 participants in the United States and evaluated the drug's bioavailability and food effect.
SACT-1 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. While it has received orphan drug designation from the FDA, this designation does not mean the drug is approved for marketing; it is still undergoing clinical trials to assess its safety and efficacy.