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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02833831 | Study to Evaluate the Effect of ALS-008176 on Cardiac Repolarization Interval in Healthy Participants | PHASE1 | COMPLETED | 103 | — | — | Jun 2, 2016 | Feb 24, 2017 | Feb 3, 2025 | 1 | United States |
Change from baseline in QTc intervals with Fredericia correction will be analyzed.
| Arm | Type | Description |
|---|---|---|
| Part 1: Group 1 | EXPERIMENTAL | Participants will receive Treatment A (a single dose of ALS-008176 1,500 mg) or Treatment B (a single dose of placebo) under fasted conditions. |
| Part 1: Group 2 | EXPERIMENTAL | Participants will receive Treatment C (a single dose of ALS-008176 2,500 mg) or Treatment D (a single dose of placebo) under fasted conditions. |
| Part 1: Group 3 | EXPERIMENTAL | Participants will receive Treatment E (a single dose of ALS-008176 3,000 mg) or Treatment F (a single dose of placebo) under fasted conditions. |
| Part 2: Sequence GHI | EXPERIMENTAL | Participants will receive Treatment G (a single dose of ALS-008176 3,000 mg + a single dose of moxifloxacin placebo under fasted conditions) then Treatment H (a single dose of ALS-008176 placebo + a single dose of moxifloxacin 400 mg under fasted conditions) then Treatment I (a single dose of ALS-008176 placebo + a single dose of moxifloxacin placebo under fasted conditions). There will be a washout period of at least 14 days between subsequent treatments. |
| Part 2: Sequence HIG | EXPERIMENTAL | Participants will receive Treatment H then Treatment I and then Treatment G. There will be a washout period of at least 14 days between subsequent treatments. |
| Part 2: Sequence IGH | EXPERIMENTAL | Participants will receive Treatment I then Treatment G and then Treatment H. There will be a washout period of at least 14 days between subsequent treatments. |
| Part 2: Sequence IHG | EXPERIMENTAL | Participants will receive Treatment I then Treatment H and then Treatment G. There will be a washout period of at least 14 days between subsequent treatments. |
| Part 2: Sequence HGI | EXPERIMENTAL | Participants will receive Treatment H then Treatment G and then Treatment I. There will be a washout period of at least 14 days between subsequent treatments. |
| Part 2: Sequence GIH | EXPERIMENTAL | Participants will receive Treatment G then Treatment I and then Treatment H. There will be a washout period of at least 14 days between subsequent treatments. |
| Name | Type | Description |
|---|---|---|
| ALS-008176 | DRUG | Participants will receive a single dose of ALS-008176 orally. |
| Placebo | DRUG | Matching Placebo will be administered. |
| Moxifloxacin | DRUG | Participants will receive a single dose of moxifloxacin 400 mg. |
Inclusion Criteria: * Each participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study * Participant must be willing and able to adhere to the prohibitions and restrictions...