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| ID | Type | Description | Link |
|---|---|---|---|
| 272201600029C-P00017-9999-1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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This is an open label, two period (fasted and fed), crossover study in up to 3 cohorts of 12 healthy adult participants per cohort (up to 36 participants in total). The pharmacokinetics (PK) of the inactive prodrug VNRX-7145, its active parent drug VNRX-5236, and ceftibuten will be evaluated after a single oral dose of ceftibuten/VNRX-7145.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Cohort 1 will assess the impact of a high fat meal. |
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| Cohort 2 | Experimental | Cohort 2 will be conducted to assess the impact of an alternative lower fat meal if administration with high fat meal has a food effect on drug exposure. |
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| Cohort 3 | Experimental | Cohort 3 will evaluate realistic fasting intervals and/or additional meal types if administration with food has a food effect on drug exposure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VNRX-7145 | Drug | Single oral dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum observed plasma concentration (Cmax) | 0 hr (predose) through 48 hours for fasting subjects and 0 hr (predose) through 72 hours for fed subjects |
| AUC0-t | Area under the plasma concentration-time curve (AUC) from time 0 up to the last quantifiable concentration at time t (AUC0-t) | 0 hr (predose) through 48 hours for fasting subjects and 0 hr (predose) through 72 hours for fed subjects |
| AUC0-inf | AUC from time 0 extrapolated to infinity (AUC0-inf) | 0 hr (predose) through 48 hours for fasting subjects and 0 hr (predose) through 72 hours for fed subjects |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kamal Hamed, MD | Basilea Pharmaceutica International Ltd, Allschwil | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON Plc. | Lenexa | Kansas | 66219 | United States |
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| ID | Term |
|---|---|
| D000077722 | Ceftibuten |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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| Ceftibuten |
| Drug |
Single oral dose |
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| Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |