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| ID | Type | Description | Link |
|---|---|---|---|
| Pemvidutide | Other Identifier | Altimmune | |
| ALT-801 | Other Identifier | Altimmune |
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This is a Phase 1, open-label, drug-drug interaction (DDI) study of pemvidutide (ALT-801) under steady state conditions on concomitantly administered medications in healthy subjects. The study will evaluate the effect of pemvidutide on the pharmacokinetics (PK) of metformin, warfarin, atorvastatin, digoxin, and the combined oral contraceptive (COC) ethinylestradiol/levonorgestrel. The study will be conducted in 3 parts, as described below. Each part will have 2 periods in a fixed sequence, where the first period is without pemvidutide administration and the second is with pemvidutide at steady state.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 Metformin and Atorvastatin with and without Pemvidutide | Experimental | In Period 1, subjects received metformin 500 mg BID on Days 1 and 2, single doses of metformin 500 mg and atorvastatin 40 mg on Day 3, and a single dose of pemvidutide 0.6 mg on Day 8. In Period 2, subjects received single doses of pemvidutide1.2 mg on Day 15 and 1.8 mg on Days 22 and 29, metformin 500 mg BID on Days 34 and 35, and pemvidutide 1.8 mg on Day 36 immediately followed by oral metformin 500 mg and atorvastatin 40 mg. |
|
| Part 2 Warfarin and Digoxin with and without Pemvidutide | Experimental | In Period 1, subjects received single doses of warfarin 10 mg and digoxin 500 mcg (0.5 mg) on Day 1, and a single dose of pemvidutide 0.6 mg on Day 8. In Period 2, subjects received single doses of pemvidutide 1.2 mg on Day 15 and 1.8 mg on Days 22 and 29, and pemvidutide1.8 mg immediately followed by warfarin 10 mg and digoxin 500 mcg (0.5 mg) on Day 36. |
|
| Part 3 Ethinylestradiol and Levonorgestrel with and without Pemvidutide | Experimental | In Period 1, subjects received a combined oral contraceptive (COC) consisting of 0.03 mg ethinylestradiol and 0.15 mg levonorgestrel once daily on Days 1 through 9 and a single dose of pemvidutide 0.6 mg on Day 15. In Period 2, subjects received single doses of pemvidutide 1.2 mg on Day 22 and 1.8 mg on Days 29 and 36. Subjects also received COC once daily on Days 35 through 42 and a single dose of pemvidutide 1.8 mg followed immediately by a single dose of COC on Day 43. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pemvidutide | Drug | Injected subcutaneously (SC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration Versus Time Curve (AUC) of metformin and atorvastatin/warfarin and digoxin in presence of steady state ALT-801 | Baseline and Day 36 | |
| Area Under the Plasma Concentration Versus Time Curve (AUC) of ethinylestradiol and levonorgestrel in presence of steady state ALT-801 | Baseline and Day 43 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax and Tmax of metformin and atorvastatin/warfarin and digoxin | Day 36 | |
| Cmax and Tmax of ethinylestradiol and levonorgestrel | Day 43 | |
| The Number of Participants with One or More Treatment-Emergent Adverse Events (TEAEs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMAX Clinical Research | Adelaide | South Australia | Australia | |||
| Nucleus Network |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C572627 | ALT-801 |
| D008687 | Metformin |
| D000069059 | Atorvastatin |
| D014859 | Warfarin |
| D004077 | Digoxin |
| D004997 | Ethinyl Estradiol |
| D016912 | Levonorgestrel |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D011758 |
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| Metformin | Drug | Taken by mouth (PO) |
|
| Atorvastatin | Drug | Taken by mouth (PO) |
|
| Warfarin | Drug | Taken by mouth (PO) |
|
| Digoxin | Drug | Taken by mouth (PO) |
|
| Ethinylestradiol and Levonorgestrel | Drug | Taken by mouth (PO) |
|
| Up to Day 77 |
| Brisbane |
| Australia |
| Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009644 | Norgestrel |
| D009652 | Norpregnenes |