Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-25 @ 9:23 PM
Study NCT ID:
NCT05358756
Status:
COMPLETED
Last Update Posted:
2022-05-26
First Post:
2022-04-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Bioavailability and Food Effect of SACT-1 and Edurant® Tablets in Healthy Adult Volunteers
Sponsor:
Aptorum International Limited
Organization:
Study Overview
Official Title:
A Phase 1, Open-label, Randomized, 3-period, 3-sequence, Single-dose Crossover Bioavailability and Food Effect Study of SACT-1 (Rilpivirine Suspension) and Edurant® Tablets in Healthy Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This was a Phase 1, open-label, randomized, single center, 3-period, 3-sequence, single-dose crossover bioavailability and food effect study between SACT-1 and Edurant® tablet.
Detailed Description:
The subject population included 16 healthy subjects (11 male, 5 female) who received each of the following treatments in a randomized sequence:
Treatment A: SACT-1, 150 mg rilpivirine oral suspension (30.0 mg of rilpivirine \[equivalent to 33.0 mg of rilpivirine hydrochloride\] in each mL), fasted Treatment B: SACT-1, 150 mg rilpivirine oral suspension (30.0 mg of rilpivirine \[equivalent to 33.0 mg of rilpivirine hydrochloride\] in each mL), fed Treatment C: Edurant, 150 mg (6 × 25 mg rilpivirine, oral tablets), fed
On the morning of Day 1 of each study period, subjects received a dose of either Treatment A, Treatment B, or Treatment C after a supervised overnight fast of at least 10 hours (fasted) or after a supervised overnight fast of at least 10 hours followed by a high-fat, high calorie meal (fed). In the fed arms of the study, subjects started the standardized high-fat, high-calorie breakfast 30 minutes prior to dosing and consumed this meal within the 30 minutes before dosing.
Blood samples were collected at pre-dose and at specified time points over 240 hours after dosing in each study period. Subjects were confined at the clinical facility from check-in until after the 48-hour blood sample collection and returned to the clinic for the 96-, 168- and 240-hour blood samples in each study period. The interval between doses was 14 days.
The plasma concentrations of rilpivirine were measured by the bioanalytical facility using a fully validated analytical procedure. Statistical analysis using an average bioavailability approach was performed to estimate the bioavailability of the test formulation relative to the reference product under fed conditions. The bioavailability of the test product under fasted and fed conditions was also compared.
For evaluation of the safety endpoint, the following assessments were performed throughout the study: collection of medication history and Adverse Events (AEs), laboratory tests (including pregnancy testing), vital signs, physical examination, and 12-lead electrocardiograms (ECGs). PK-ECG correlation analysis was performed to evaluate the correlation between drug concentrations and time-matched baseline corrected values for QTc interval, ΔQTcF and ΔQTcB.
Treatment A: SACT-1, 150 mg rilpivirine oral suspension (30.0 mg of rilpivirine \[equivalent to 33.0 mg of rilpivirine hydrochloride\] in each mL), fasted Treatment B: SACT-1, 150 mg rilpivirine oral suspension (30.0 mg of rilpivirine \[equivalent to 33.0 mg of rilpivirine hydrochloride\] in each mL), fed Treatment C: Edurant, 150 mg (6 × 25 mg rilpivirine, oral tablets), fed
On the morning of Day 1 of each study period, subjects received a dose of either Treatment A, Treatment B, or Treatment C after a supervised overnight fast of at least 10 hours (fasted) or after a supervised overnight fast of at least 10 hours followed by a high-fat, high calorie meal (fed). In the fed arms of the study, subjects started the standardized high-fat, high-calorie breakfast 30 minutes prior to dosing and consumed this meal within the 30 minutes before dosing.
Blood samples were collected at pre-dose and at specified time points over 240 hours after dosing in each study period. Subjects were confined at the clinical facility from check-in until after the 48-hour blood sample collection and returned to the clinic for the 96-, 168- and 240-hour blood samples in each study period. The interval between doses was 14 days.
The plasma concentrations of rilpivirine were measured by the bioanalytical facility using a fully validated analytical procedure. Statistical analysis using an average bioavailability approach was performed to estimate the bioavailability of the test formulation relative to the reference product under fed conditions. The bioavailability of the test product under fasted and fed conditions was also compared.
For evaluation of the safety endpoint, the following assessments were performed throughout the study: collection of medication history and Adverse Events (AEs), laboratory tests (including pregnancy testing), vital signs, physical examination, and 12-lead electrocardiograms (ECGs). PK-ECG correlation analysis was performed to evaluate the correlation between drug concentrations and time-matched baseline corrected values for QTc interval, ΔQTcF and ΔQTcB.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: