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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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The main purpose of the study is to characterize the systemic pharmacokinetic (PK) parameters (plasma, whole blood) of tebipenem (TBP) pharmacologically active moiety of tebipenem-pivoxil-hydrobromide (TBP-PI-HBr) and its urinary excretion at different dose levels in healthy participants. The study also aims to assess the plasma and urine PK parameters of SPR1349, a major metabolite of TBP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Cohort 1 | Experimental | Participants will receive TBP-PI-HBr, 900 milligrams (mg) tablets orally, as a single dose under fasted condition on Day 1. |
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| Part A: Cohort 2 (Fasted/Fed) | Experimental | Participants will receive TBP-PI-HBr, 1200 mg, tablets, orally, as a single dose under fasted and fed conditions on Day 1 and Day 3, as per the assigned crossover sequence. |
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| Part B: Cohort 3 | Experimental | Participants will receive TBP-PI-HBr, 600 mg, orally as a single dose on Day 1, followed by 9 doses every 6 hours from Day 3 through Day 5. (first and ninth dose will be given under fasted conditions). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TBP-PI-HBr | Drug | TBP-PI-HBr film-coated immediate-release tablets |
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| Measure | Description | Time Frame |
|---|---|---|
| Part A and B: Maximum Observed Concentration (Cmax) of TBP in Plasma and Blood | Cohort 1: Pre-dose and at multiple timepoints post-dose up to Day 3; Cohort 2: Pre-dose and at multiple timepoints post-dose up to Day 5; Cohort 3: pre-dose and at multiple timepoints post-dose up to Day 7 | |
| Part A and B: Time to Cmax (Tmax) of TBP in Plasma and Blood | Cohort 1: Pre-dose and at multiple timepoints post-dose up to Day 3; Cohort 2: Pre-dose and at multiple timepoints post-dose up to Day 5; Cohort 3: pre-dose and at multiple timepoints post-dose up to Day 7 | |
| Part A and B: Area Under the Concentration-Time Curve (AUC) Extrapolated to Infinity [AUC(0-inf)] of TBP in Plasma and Blood | Cohort 1: Pre-dose and at multiple timepoints post-dose up to Day 3; Cohort 2: Pre-dose and at multiple timepoints post-dose up to Day 5; Cohort 3: pre-dose and at multiple timepoints post-dose up to Day 7 | |
| Part A and B: AUC From Time Zero to the Time of the Last Evaluable Concentration [AUC(0-t)] of TBP in Plasma and Blood | Cohort 1: Pre-dose and at multiple timepoints post-dose up to Day 3; Cohort 2: Pre-dose and at multiple timepoints post-dose up to Day 5; Cohort 3: pre-dose and at multiple timepoints post-dose up to Day 7 | |
| Part A and B: Amount Excreted in Urine (Ae) of TBP | Cohort 1: Pre-dose and at multiple timepoints post-dose up to Day 3; Cohort 2: Pre-dose and at multiple timepoints post-dose up to Day 5; Cohort 3: pre-dose and at multiple timepoints post-dose up to Day 7 | |
| Part A and B: Fraction of Dose Excreted in Urine (Fe) of TBP | Cohort 1: Pre-dose and at multiple timepoints post-dose up to Day 3; Cohort 2: Pre-dose and at multiple timepoints post-dose up to Day 5; Cohort 3: pre-dose and at multiple timepoints post-dose up to Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Part B: Tmax of SPR1349 in Plasma | Pre-dose and at multiple timepoints post-dose up to Day 7 | |
| Part B: Cmax of SPR1349 in Plasma | Pre-dose and at multiple timepoints post-dose up to Day 7 | |
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Inclusion Criteria
Exclusion Criteria:
Note: Other inclusion/exclusion criteria may also apply
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Facility, Salt Lake City | Salt Lake City | Utah | 84124 | United States |
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The study involves 2 parts (A and B) and 3 cohorts (Cohort 1, 2 and 3) of which Cohort 2 has a crossover design.
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| Part B: AUC From Time Zero to 6 Hours Post-dose AUC(0-6) of TBP in Plasma and Blood | Pre-dose and at multiple timepoints post-dose up to Day 7 |
| Part B: Ae of SPR1349 | Pre-dose and at multiple timepoints post-dose up to Day 7 |
| Part B: Fe of SPR1349 | Pre-dose and at multiple timepoints post-dose up to Day 7 |
| Part B: AUC(0-inf) of SPR1349 in Plasma |
| Pre-dose and at multiple timepoints post-dose up to Day 7 |
| Part B: AUC(0-t) of SPR1349 in Plasma | Pre-dose and at multiple timepoints post-dose up to Day 7 |
| Part B: AUC(0-6) of SPR1349 in Plasma | Pre-dose and at multiple timepoints post-dose up to Day 7 |
| Part B: Plasma AUC Ratio of SPR1349 to TBP | Pre-dose and at multiple timepoints post-dose up to Day 7 |
| Part B: Ae Ratio of SPR1349 to TBP | Pre-dose and at multiple timepoints post-dose up to Day 7 |
| Parts A and B: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 1 to Day 21 |
| ID | Term |
|---|---|
| C500135 | tebipenem |
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