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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04142762 | A Study to Assess CYP3A4 Modulator, Oral Contraceptive, and pH Modifier Drug Interactions for ABI-H2158 in Healthy Adults | PHASE1 | COMPLETED | 80 | — | — | Oct 18, 2019 | Jan 29, 2020 | Mar 4, 2020 | 1 | United States |
| NCT04083716 | A Study to Assess the Relative Bioavailability and Food Effect of ABI-H2158 in Healthy Adults | PHASE1 | COMPLETED | 15 | — | — | Sep 6, 2019 | Oct 7, 2019 | Nov 29, 2019 | 1 | United States |
| NCT03714152 | A Study of ABI-H2158 in Healthy Volunteers and Patients With Chronic Hepatitis B | PHASE1 | COMPLETED | 80 | — | — | Nov 13, 2018 | Jan 7, 2021 | Jan 27, 2021 | 14 | United States, Australia +5 |
| Arm | Type | Description |
|---|---|---|
| Cohort 1: ABI-H2158 + Itraconazole | EXPERIMENTAL | Oral ABI-H2158 on Days 1 and 9; oral itraconazole once-daily (QD) on Days 6 through 13 |
| Cohort 2: ABI-H2158 + Rifampin | EXPERIMENTAL | Oral ABI-H2158 on Days 1 and 12; oral rifampin QD on Days 6 through 16 |
| Cohort 3: ABI-H2158 + Esomeprazole | EXPERIMENTAL | Oral ABI-H2158 on Days 1 and 11; oral esomeprazole QD on Days 6 through 11 |
| Cohort 4: ABI-H2158 + Midazolam | EXPERIMENTAL | Oral midazolam on Days 1 and 11; oral ABI-H2158 QD on Days 2 through 11 |
| Cohort 5: ABI-H2158 + Oral Contraceptive | EXPERIMENTAL | Cycle 1: active oral contraceptive (ethinyl estradiol/levonorgestrel) QD on Days 1 through 21 and oral placebo QD on Days 22 through 28; Cycle 2: active oral contraceptive QD on Days 1 through 21, oral placebo QD on Days 22 through 26, and oral ABI-H2158 QD on Days 11 through 24 |
| Group 1 | EXPERIMENTAL | ABI-H2158 Reference Formulation in a fasting state on Day 1 (Period 1), then ABI-H2158 Test Formulation in a fasting state on Day 8 (Period 2), then ABI-H2158 Test Formulation after a high-fat meal on Day 15 (Period 3) |
| Group 2 | EXPERIMENTAL | ABI-H2158 Test Formulation in a fasting state on Day 1 (Period 1), then ABI-H2158 Test Formulation after a high-fat meal on Day 8 (Period 2), then ABI-H2158 Reference Formulation in a fasting state on Day 15 (Period 3) |
| Group 3 | EXPERIMENTAL | ABI-H2158 Test Formulation after a high-fat meal on Day 1 (Period 1), then ABI-H2158 Reference Formulation in a fasting state on Day 8 (Period 2), then ABI-H2158 Test Formulation in a fasting state on Day 15 (Period 3) |
| ABI-H2158 | EXPERIMENTAL | ABI-H2158 in varying doses of tablets by mouth without and with food for 1 day or 10 days |
| Matching Placebo for ABI-H2158 | PLACEBO_COMPARATOR | Matching Placebo in varying doses of tablets by mouth without and with food for 1 day or 10 days |
| Name | Type | Description |
|---|---|---|
| ABI-H2158 | DRUG | ABI-H2158 tablets |
| Itraconazole | DRUG | Itraconazole capsules |
| Rifampin | DRUG | Rifampin capsules |
| Midazolam | DRUG | Midazolam syrup |
| Ethinyl Estradiol / Levonorgestrel | DRUG | Ethinyl Estradiol / Levonorgestrel tablets |
| Esomeprazole | DRUG | Esomeprazole capsules |
| Placebo matching oral contraceptive | DRUG | Placebo matching Ethinyl Estradiol / Levonorgestrel tablets |
| ABI-H2158 Reference Formulation | DRUG | ABI-H2158 tablets Reference Formulation |
| ABI-H2158 Test Formulation | DRUG | ABI-H2158 tablets Test Formulation |
| Placebo for ABI-H2158 | DRUG | Sugar pill manufactured to mimic the ABI-H2158 5 mg or 25 mg tablets |
Inclusion Criteria: 1. No clinically significant abnormal findings on physical exam, medical history, or clinical laboratory results at screening. 2. Cohort 5: naive to the use of oral contraceptives. Exclusion Criteria: 1\. Positive test results for human immunodeficiency virus (HIV) or hepatiti...