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This study is a single-center, open-label, 2-cohort, multiple dose, fixed-sequence, DDI study in healthy adult subjects. Healthy volunteers will be administered multiple oral doses of ATI-2173 in combination with tenofovir disoproxil fumarate and assessed for safety and tolerability including blood tests to show how the body metabolizes and eliminates the investigational drug as well as how the investigational drug interacts with tenofovir disoproxil fumarate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATI-2173. | Experimental | ATI-2173 |
|
| Tenofovir Disoproxil Fumarate | Experimental | Tenofovir disoproxil fumarate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATI-2173 50 mg | Drug | ATI-2173 is a liver-targeted phosphoramidate oral prodrug of clevudine designed to enhance anti-HBV activity while decreasing systemic exposure to clevudine. It will be dosed as a capsule by mouth |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of ATI-2173, clevudine, and M1 in plasma | Through end of study, approximately 3 months | |
| AUCtau of ATI-2173, clevudine, and M1 in plasma | Through end of study, approximately 3 months | |
| AUC0-t of ATI-2173, clevudine, and M1 in plasma | Through end of study, approximately 3 months | |
| Cmax of tenofovir | Through end of study, approximately 3 months | |
| Cmin,ss of tenofovir | Through end of study, approximately 3 months | |
| AUC0-tau of tenofovir | Through end of study, approximately 3 months | |
| AUC0-t of tenofovir | Through end of study, approximately 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events | Through end of study, approximately 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma trough concentrations of tenofovir, ATI-2173, clevudine, and M1 | Days 18, 19, 20 and 21 |
Inclusion Criteria:
9. Agrees to abstain from blood or plasma donation from the Screening visit until 3 months after the last study drug administration 10. If female, must meet one of the following criteria:
Is of childbearing potential and agrees to use an acceptable contraceptive method. Acceptable contraceptive methods include:
Is of non-childbearing potential, defined as surgically sterile (ie, has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation/occlusion) or in a postmenopausal state (at least 1 year without menses without an alternative medical condition prior to Screening), as confirmed by follicle-stimulating hormone levels (≥ 40 mIU/mL).
11. A male study subject that engages in sexual activity that has the risk of pregnancy must:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altasciences | Montreal | Quebec | H3P 3P1 | Canada |
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| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
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| Tenofovir 300Mg Oral Tablet | Drug | Tenofovir is an oral nucleotide analogue reverse transcriptase inhibitor used for chronic hepatitis B virus. It will be dosed as a tablet by mouth |
|
|
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |