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This study is designed to assess 1) the effect of multiple doses of itraconazole (CYP3A4 inhibitor), rifampin (CYP3A4 inducer), and esomeprazole (pH modifier) on the pharmacokinetics of a single oral dose of ABI-H2158, and 2) the effect of steady-state oral ABI-H2158 on the pharmacokinetics of midazolam (sedative) and levonorgestrel/ethinyl estradiol (active oral contraceptive) in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABI-H2158 | Drug | ABI-H2158 tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration time curve (AUC) of ABI-H2158 | before dosing and at pre-specified time points up to Day 17 | |
| Maximum observed plasma concentration (Cmax) of ABI-H2158 | before dosing and at pre-specified time points up to Day 17 | |
| AUC of Midazolam | before dosing and at pre-specified time points up to Day 12 | |
| Cmax of Midazolam | before dosing and at pre-specified time points up to Day 17 | |
| AUC of ethinyl estradiol and levonorgestrel | before dosing and at pre-specified time points up to 5 days after dosing on Day 21 of Cycle 1 and Cycle 2. Cycle 1 is 28 days and Cycle 2 is 26 days | |
| Cmax of ethinyl estradiol and levonorgestrel | before dosing and at pre-specified time points up to 5 days after dosing on Day 21 of Cycle 1 and Cycle 2. Cycle 1 is 28 days and Cycle 2 is 26 days |
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Inclusion Criteria:
Exclusion Criteria:
1. Positive test results for human immunodeficiency virus (HIV) or hepatitis B or C.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Study Lead | Assembly Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Tempe | Arizona | 85283 | United States |
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| 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 |
|
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| D012293 | Rifampin |
| D008874 | Midazolam |
| D019304 | Ethinyl Estradiol-Norgestrel Combination |
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D004997 | Ethinyl Estradiol |
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |
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