| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06105983 | A Study to Learn How a Medicine That Reduces Stomach Acid Affects the Level of Sisunatovir in the Blood of Healthy Adults. | PHASE1 | COMPLETED | 40 | — | — | Nov 3, 2023 | Jul 19, 2024 | Apr 24, 2025 | 1 | Belgium |
| NCT05994963 | A Study to Compare Different Preparations of Sisunatovir in Healthy Adult Participants. | PHASE1 | COMPLETED | 25 | — | — | Sep 1, 2023 | Feb 26, 2024 | May 6, 2025 | 1 | Belgium |
| NCT05878522 | A Study to Investigate the Effects of Sisunatovir on QTc Interval in Healthy Adult Participants. | PHASE1 | COMPLETED | 43 | — | — | May 15, 2023 | Oct 30, 2023 | Dec 6, 2024 | 1 | United States |
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
AUClast was calculated using linear/log trapezoidal method. Treatment A = sisunatovir 200 mg PIC under fasted condition; reference treatment. Treatment B = sisunatovir 200 mg WGT under fasted condition; test treatment.
AUCinf was calculated as AUClast + (Clast\*/kel), where Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis, and kel is the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve. Treatment A = sisunatovir 200 mg PIC under fasted condition; reference treatment. Treatment B = sisunatovir 200 mg WGT under fasted condition; test treatment.
Treatment A = sisunatovir 200 mg PIC under fasted condition; reference treatment. Treatment B = sisunatovir 200 mg WGT under fasted condition; test treatment.
The relationship between sisunatovir plasma concentration and change from baseline in Fridericia's heart-rate corrected QT interval were analyzed using a model-based concentration-QTc analysis consistent with the Scientific White Paper on Concentration-QT Modeling. Baseline was defined as the mean of the 3 averages of the triplicate electrocardiogram (ECG) measurements taken before dosing on Day 1 within each period. Mean and CI statistics were based on the individual (within subject) corrected differences between sisunatovir and placebo exposures.
| Arm | Type | Description |
|---|---|---|
| Treatment A | EXPERIMENTAL | Part 1: Sisunatovir without rabeprazole |
| Treatment B | ACTIVE_COMPARATOR | Part 1: Sisunatovir with 40 mg rabeprazole |
| Treatment C | ACTIVE_COMPARATOR | Part 2: Sisunatovir suspension without rabeprazole |
| Treatment D | EXPERIMENTAL | Part 2: Sisunatovir suspension with 20 mg rabeprazole |
| Treatment E | EXPERIMENTAL | Part 2: Sisunatovir suspension with 40 mg rabeprazole |
| Part 1 Treatment A | EXPERIMENTAL | 4 capsules of sisunatovir in fasted state |
| Part 1 Treatment B | EXPERIMENTAL | 2 tablets of sisunatovir in fasted state |
| Part 1 Treatment C | EXPERIMENTAL | 2 tablets of sisunatovir with a high-fat meal |
| Part 2 Treatment B | EXPERIMENTAL | 2 tablets of sisunatovir in fasted sate |
| Part 2 Treatment D | EXPERIMENTAL | 2 tablets of sisunatovir with a low-fat meal |
| Name | Type | Description |
|---|---|---|
| Sisunatovir | DRUG | Single Dose |
| Rabeprazole 40 mg | DRUG | Tablets once daily for 7 days |
| Sisunatovir suspension | DRUG | Tablets once daily for 7 days |
| Rabeprazole 20 mg | DRUG | Tablets once daily for 7 days |
| placebo | DRUG | 6 capsules administered Q12 hours for 5 doses |
| moxifloxacin | DRUG | 6 capsules of placebo administered Q12 hours for 4 doses, followed by a single tablet of moxifloxacin |
Inclusion Criteria: * Male and female participants aged 18 years or older (or the minimum age of consent in accordance with local regulations) at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, blood pressure, ...