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This study aims to assess the safety, tolerability, and pharmacokinetics (PK) of oral doses of surotomycin (CB-183,315) administered for 14 consecutive days in healthy males and females.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surotomycin 0.5 g | Experimental | Two oral doses of 0.25 g surotomycin in hard gelatin capsules per day, taken at least 8 hours apart, for 14 days |
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| Surotomycin 1 g | Experimental | Two oral doses of 0.5 g surotomycin in hard gelatin capsules per day, taken at least 8 hours apart, for 14 days |
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| Surotomycin 2 g | Experimental | Two oral doses of 1 g surotomycin in hard gelatin capsules per day, taken at least 8 hours apart, for 14 days |
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| Placebo | Placebo Comparator | Two oral doses of placebo for surotomycin in hard gelatin capsules per day, taken at least 8 hours apart, for 14 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surotomycin | Drug | Two oral doses of surotomycin in hard gelatin capsules totaling either 0.5, 1 or 2 g per day, for 14 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with an Adverse Event (AE) | Up to Day 21 | |
| Number of participants who discontinued study treatment due to an AE | Up to Day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28347318 | Derived | Chandorkar G, Zhan Q, Donovan J, Rege S, Patino H. Pharmacokinetics of surotomycin from phase 1 single and multiple ascending dose studies in healthy volunteers. BMC Pharmacol Toxicol. 2017 Mar 28;18(1):24. doi: 10.1186/s40360-017-0123-z. |
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| ID | Term |
|---|---|
| C574454 | CB-183,315 |
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| Placebo | Drug | Two oral doses of placebo for surotomycin in hard gelatin capsules per day, for 14 days |
|