Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07161037 | Phase 2a Study of VX-407 in Participants With ADPKD Who Have a Subset of PKD1 Gene Variants (AGLOW) | PHASE2 | RECRUITING | 24 | — | — | Nov 19, 2025 | Dec 31, 2027 | May 13, 2026 | 42 | United States, Belgium +6 |
| NCT07074327 | Effects of VX-407 on the Pharmacokinetics of Oral Contraceptives in Healthy Participants | PHASE1 | COMPLETED | 74 | — | — | Jul 11, 2025 | Feb 27, 2026 | Mar 30, 2026 | 1 | United States |
| NCT07022119 | A Phase 1 Study Evaluating Safety, Tolerability, and Pharmacokinetics of VX-407 in Healthy Participants | PHASE1 | COMPLETED | 32 | — | — | Jun 12, 2025 | Feb 24, 2026 | Mar 27, 2026 | 1 | United States |
| NCT06345755 | A Phase 1 Study to Evaluate Safety, Tolerability, and Pharmacokinetics of VX-407 in Healthy Participants | PHASE1 | COMPLETED | 159 | — | — | Apr 17, 2024 | Jun 13, 2025 | Jul 14, 2025 | 2 | United States, Canada |
| Arm | Type | Description |
|---|---|---|
| VX-407 | EXPERIMENTAL | Participants will receive VX-407 for up to 52 weeks. |
| Part A: VX-407 With Levonorgestrel/Ethinyl Estradiol (LNG/EE) | EXPERIMENTAL | Participants will receive a single dose of LNG/EE on Days 1 and 21 in fasted state. Participants will also receive VX-407 every 12 hours (q12h) from Days 8 through 26 in fasted state. |
| Part B (Optional): VX-407 With Norgestimate/Ethinyl Estradiol (NGM/EE) | EXPERIMENTAL | Participants will receive a single dose of NGM/EE on Days 1 and 23 in fasted state. Participants will also receive VX-407 q12h from Days 10 through 30 in fasted state. |
| Part C (Optional): VX-407 With Norethindrone/Ethinyl Estradiol (NET/EE) | EXPERIMENTAL | Participants will receive a single dose of NET/EE on Days 1 and 19 in fasted state. Participants will also receive VX-407 q12h from Days 6 through 22 in fasted state. |
| Part D (Optional): VX-407 With Drospirenone/Ethinyl Estradiol (DRSP/EE) | EXPERIMENTAL | Participants will receive a single dose of DRSP/EE on Days 1 and 21 in fasted state. Participants will also receive VX-407 q12h from Days 8 through 26 in fasted state. |
| Part A: Single Ascending Dose | EXPERIMENTAL | Participants will be randomized to receive a single dose of VX-407. |
| Placebo Part A | PLACEBO_COMPARATOR | Participants will be randomized to receive placebo matched to VX-407. |
| Part B: Multiple Ascending Dose | EXPERIMENTAL | Participants will be randomized to receive multiple doses of VX-407. |
| Placebo Part B | PLACEBO_COMPARATOR | Participants will be randomized to receive placebo matched to VX-407. |
| Part A: Single Ascending Dose (SAD) | EXPERIMENTAL | Participants will be randomized to receive a single dose of different dose levels of VX-407. |
| Part A: Placebo | PLACEBO_COMPARATOR | Participants will be randomized to receive placebo matched to VX-407. |
| Part B: Multiple Ascending Dose (MAD) | EXPERIMENTAL | Participants will be randomized to receive multiple doses of different dose levels of VX-407. The dose levels will be determined based on the data from Part A. |
| Part B: Placebo | PLACEBO_COMPARATOR | Participants will be randomized to receive multiple doses of placebo matched to VX-407. |
| Part C: Drug-Drug Interaction | EXPERIMENTAL | Participants will be administered Midazolam (MDZ) in the presence or absence of VX-407. The dose levels will be determined based on the data from Part B. |
| Part D | EXPERIMENTAL | Participants will be randomized to receive VX-407 in 1 of 3 treatment sequences with 3 dosing periods to assess the relative bioavailability of VX-407 formulations and the effect of food on the pharmacokinetics of VX-407. |
| Name | Type | Description |
|---|---|---|
| VX-407 | DRUG | Tablets for oral administration. |
| LNG/EE | DRUG | Combination Tablets for Oral Administration. |
| NGM/EE | DRUG | Combination Tablets for Oral Administration. |
| NET/EE | DRUG | Combination Tablets for Oral Administration. |
| DRSP/EE | DRUG | Combination Tablets for Oral Administration. |
| Placebo | DRUG | Suspension for oral administration. |
| Midazolam | DRUG | Syrup for oral administration. |
Key Inclusion Criteria: * A pre-existing diagnosis of ADPKD as defined in the protocol * Willing and able to comply with scheduled visits and other study procedures * Participants with ADPKD with Mayo imaging classification (MIC) status of 1B (with htTKV ≥250 mL/m), 1C, 1D, or 1E confirmed by abdom...