Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VX-787 · 2 trials · 2 indications
Area under the curve (AUC) of the log10 nasal viral load is measured by quantitative reverse transcriptase polymerase chain reaction (qRT-PCR).
Based on the individual plasma concentration-time data, using the actual sampling times the following PK parameters will be derived: Ctrough, Cmin, Cmax, tmax, AUC12h, Cavg, FI Ratio Cmax,test/refrence (ref), Ratio Cmin,test/ref and ratio AUC12h, test/ref
Safety and tolerability will be evaluated throughout the study from signing of the ICF onwards until the last study-related activity. The study will include the following evaluations of safety and tolerability: Adverse Events, Clinical Laboratory Test, Electrocardiograms, Vital Signs, Physical Exams.
Pharmacokinetic parameters will include assessment of Ctrough, Cmin, Cmax, tmax, AUC12h, Cavg, FI Ratio Cmax,test/ref, ratio Cmin,test/ref and ratio AUC12h,test/ref.
| Arm | Type | Description |
|---|---|---|
| VX-787 Placebo BID + Oseltamivir Placebo BID | PLACEBO_COMPARATOR | Subjects will receive 10 doses of matching placebo of VX-787 and Oseltamivir twice daily (BID) with approximately 12 hour (+/- 2) intervals, over 5-6 days. |
| VX-787 300 mg BID + Oseltamivir Placebo BID | ACTIVE_COMPARATOR | Subjects will receive 10 doses of VX-787 300 milligram (mg) tablet along with matching placebo of Oseltamivir twice daily (BID) with approximately 12 hour (+/- 2) intervals, over 5-6 days. |
| VX-787 600 mg BID + Oseltamivir Placebo BID | ACTIVE_COMPARATOR | Subjects will receive 10 doses of VX-787 600 mg (2\*300 mg tablets) along with matching placebo of Oseltamivir twice daily (BID) with approximately 12 hour (+/- 2) intervals, over 5-6 days. |
| VX-787 600 mg BID + Oseltamivir 75 mg BID | ACTIVE_COMPARATOR | Subjects will receive 10 doses of VX-787 600 mg tablets (2\*300 mg tablets) along with 75 mg Oseltamivir capsule twice daily (BID) with approximately 12 hour (+/- 2) intervals, over 5-6 days. |
| Part 1 | EXPERIMENTAL | Participants will receive in random order Treatment A (VX-787, 600 mg tablet 2 times a day on Day 1 to 4, followed by VX 787, 600 mg tablet on Day 5); Treatment B (Oseltamivir, 75 mg capsule 2 times a day on Day 1 to 4, followed by oseltamivir 75 mg capsule in the morning on Day 5) or Treatment C (VX-787, 600 mg tablet, 2 times a day orally + oseltamivir, 75 mg capsule, 2 times a day on Day 1 to 4, followed by a single dose of VX-787, 600 mg + oseltamivir, 75 mg capsule on Day 5). Each participant will receive all three treatments (Treatment A, B and C) in a random sequence. |
| Part 2 VX-787 | EXPERIMENTAL | Participants will receive VX-787, 600 mg, tablet 2 times a day, orally on Day 1 to Day 9, followed by single dose of VX-787, 600 mg on Day 10. |
| Part 2 Placebo | EXPERIMENTAL | Participants will receive placebo matching to VX-787, 2 times a day, orally on Day 1 to Day 9, followed by single dose of matching placebo on Day 10. |
| Name | Type | Description |
|---|---|---|
| VX-787 300 mg | DRUG | A oral dose of 300 mg VX-787 tablet will be administered over 5-6 days. |
| VX-787 600 mg | DRUG | A oral dose of VX-787 600 mg (formulated as 2\*300 mg tablets) will be administered over 5-6 days. |
| Oseltamivir 75 mg | DRUG | A oral dose of 75 mg Oseltamivir capsule will be administered over 5-6 days. |
| Placebo | DRUG | Subjects will receive matching placebo of Oseltamivir |
| VX-787 | DRUG | Participants will receive VX-787, 600 mg either two times a day or once a day in either of the Part. |
| Oseltamivir | DRUG | Participants will receive Oseltamivir 75 mg either two times a day or once a day in either of the Part. |
Inclusion Criteria: Part A 1. Willing and able to comply with the NP swab procedure 2. Subject will sign and date an informed consent form (ICF) 3. Presenting to the clinic with symptoms suggestive of a diagnosis of acute influenza. Symptoms include oral temperature ≥38°C (100.4°F) within the prior...
VX-787 is an investigational small molecule being developed for the treatment of acute uncomplicated seasonal influenza A in adults. It has been studied in healthy volunteers as well. The drug is currently in clinical development and is not approved by the FDA.
VX-787 is being developed by Johnson & Johnson (NYSE: JNJ). The company has sponsored clinical trials to evaluate the drug's safety and efficacy in treating influenza A and in healthy subjects.
VX-787 has completed Phase 1 and Phase 2 clinical trials. The Phase 1 trial assessed drug-drug interactions with oseltamivir in healthy volunteers, while the Phase 2 trial studied the drug in adults with acute uncomplicated seasonal influenza A. It remains investigational.
VX-787 has been studied in two completed trials: NCT02262715, a Phase 1 drug-drug interaction study with oseltamivir in healthy volunteers in Belgium, and NCT02342249, a Phase 2 study of acute uncomplicated seasonal influenza A in adults across multiple countries.
No, VX-787 is not the same as oseltamivir. VX-787 is an investigational drug being developed by Johnson & Johnson, while oseltamivir is an approved antiviral medication. The Phase 1 trial NCT02262715 specifically studied the drug-drug interaction between VX-787 and oseltamivir.