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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03036813 | Study to Evaluate the Effect of Voxelotor Administered Orally to Patients With Sickle Cell Disease (GBT_HOPE) | PHASE3 | COMPLETED | 449 | — | — | Dec 1, 2016 | Oct 8, 2019 | Jul 27, 2023 | 62 | United States, Canada +10 |
| NCT03041909 | An Extension Study to Further Evaluate the Safety, Tolerability of GBT440 in Patients With Sickle Cell Disease Who Participated in the Study GBT440-001 | PHASE2 | COMPLETED | 5 | — | — | Aug 1, 2016 | Aug 1, 2017 | Jan 1, 2019 | - | — |
| NCT02567682 | Drug Interaction Study of GBT440 With Caffeine, S-warfarin, Omeprazole, and Midazolam in Healthy Subjects | PHASE1 | COMPLETED | 24 | — | — | Sep 1, 2015 | May 1, 2016 | Apr 11, 2017 | - | — |
| NCT02567695 | A Single-Dose Relative Bioavailability Study Of GBT440 300 mg Capsules in Healthy Subjects | PHASE1 | COMPLETED | 26 | — | — | Sep 1, 2015 | Jun 1, 2016 | Apr 11, 2017 | - | — |
| NCT05981365 | Voxelotor CYP and Transporter Cocktail Interaction Study | PHASE1 | COMPLETED | 44 | — | — | Apr 17, 2023 | Oct 4, 2023 | Nov 22, 2024 | 1 | United States |
Number of participants with increase in Hb \>1 g/dL from Baseline to Week 24
AUCt was calculated using the linear/log trapezoidal rule.
AUCt was calculated using the linear/log trapezoid rule.
AUCt was calculated using the linear/log trapezoid rule.
AUCt was calculated using the linear/log trapezoid rule.
AUCt was calculated using the linear/log trapezoid rule.
AUCinf was calculated as AUClast + Clast/lamda z, where AUClast: area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration. Clast is the last measurable concentration and lamda z: apparent terminal elimination rate constant.
AUCinf was calculated as AUClast + Clast/lamda z, where AUClast: area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration. Clast is the last measurable concentration and lamda z: apparent terminal elimination rate constant.
AUCinf was calculated as AUClast + Clast/lamda z, where AUClast: area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration. Clast is the last measurable concentration and lamda z: apparent terminal elimination rate constant.
AUCinf was calculated as AUClast + Clast/lamda z, where AUClast: area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration. Clast is the last measurable concentration and lamda z: apparent terminal elimination rate constant.
AUCinf was calculated as AUClast + Clast/lamda z, where AUClast: area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration. Clast is the last measurable concentration and lamda z: apparent terminal elimination rate constant.
AUCt was calculated using the linear/log trapezoid rule.
AUCt was calculated using the linear/log trapezoid rule.
AUCt was calculated using the linear/log trapezoid rule.
AUCinf was calculated as AUClast + Clast/lamda z, where AUClast: area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration. Clast is the last measurable concentration and lamda z: apparent terminal elimination rate constant.
AUCinf was calculated as AUClast + Clast/lamda z, where AUClast: area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration. Clast is the last measurable concentration and lamda z: apparent terminal elimination rate constant.
AUCinf was calculated as AUClast + Clast/lamda z, where AUClast: area under the plasma concentration-time curve from time 0 to time of the last quantifiable concentration. Clast is the last measurable concentration and lamda z: apparent terminal elimination rate constant.
| Arm | Type | Description |
|---|---|---|
| Dose 1 | ACTIVE_COMPARATOR | voxelotor |
| Dose 2 | ACTIVE_COMPARATOR | voxelotor |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Part A | EXPERIMENTAL | To evaluate the effect of multiple doses of voxelotor on the plasma pharmacokinetics (PK) of a single dose of bupropion, repaglinide, flurbiprofen, omeprazole, and midazolam |
| Part B | EXPERIMENTAL | To evaluate the effect of multiple doses of voxelotor on the plasma PK of a single dose of metformin, furosemide, and rosuvastatin |
| Name | Type | Description |
|---|---|---|
| voxelotor | DRUG | - |
| Placebo | OTHER | - |
| GBT440 | DRUG | Oral drug |
| Bupropion | DRUG | Drug drug interaction |
| Repaglinide | DRUG | Drug drug interaction |
| Flurbiprofen | DRUG | Drug drug interaction |
| Omeprazole | DRUG | Drug drug interaction |
| Midazolam | DRUG | Drug drug interaction |
| Metformin | DRUG | Drug drug interaction |
| Furosemide | DRUG | Drug drug interaction |
| Rosuvastatin | DRUG | Drug drug interaction |
Inclusion Criteria: 1. Male or female study participants with sickle cell disease 2. Participants have had at least 1 episode of vaso-occlusive crisis (VOC) in the past 12 months. 3. Age 12 to 65 years 4. Hemoglobin (Hb) ≥5.5 and ≤10.5 g/dL during screening 5. For participants taking hydroxyurea (H...