Condition or disease | Intervention/treatment | Phase |
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Acinetobacter Baumannii-calcoaceticus Complex Infections | Drug: ETX2514 Drug: 14C-ETX2514 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 8 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Single Period, Open Label, Phase 1 Study to Determine the Excretion and Metabolism of 14C-ETX2514 Administered Intravenously in Healthy Male Subjects |
Actual Study Start Date : | June 21, 2019 |
Actual Primary Completion Date : | July 26, 2019 |
Actual Study Completion Date : | July 26, 2019 |
Arm | Intervention/treatment |
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Experimental: ETX2514 and 14C-ETX2514
Participants will receive a single intravenous infusion of 1 gram non-labeled ETX2514 and 1 microCurie (µCi) of 14C-ETX2514 in normal saline, administered as a 3-hour infusion.
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Drug: ETX2514
intravenous infusion
Drug: 14C-ETX2514 intravenous infusion
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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Male participants with female partners of childbearing potential may be enrolled if they are:
Exclusion Criteria:
Use of any prescription (including proton pump inhibitors [PPIs] and diuretics) or non-prescription drugs, including over-the-counter medication, health supplements, non-routine vitamins and herbal products such as St. John's Wort, within 2 weeks prior to study drug administration unless discussed and agreed with the Sponsor's medical representative in writing. Use of the following may be allowed within the 2 weeks prior to study drug administration:
Participants who have any of the following abnormalities on laboratory values at Screening or on Day -1 including:
United States, Maryland | |
Pharmaron Clinical Pharmacology Center | |
Baltimore, Maryland, United States, 21201 |
Tracking Information | |||||
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First Submitted Date ICMJE | July 10, 2019 | ||||
First Posted Date ICMJE | July 15, 2019 | ||||
Last Update Posted Date | August 30, 2019 | ||||
Actual Study Start Date ICMJE | June 21, 2019 | ||||
Actual Primary Completion Date | July 26, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Study to Determine the Excretion and Metabolism of 14C-ETX2514 Administered Intravenously in Healthy Male Subjects | ||||
Official Title ICMJE | Single Period, Open Label, Phase 1 Study to Determine the Excretion and Metabolism of 14C-ETX2514 Administered Intravenously in Healthy Male Subjects | ||||
Brief Summary | This study will be conducted to determine the routes and rates of excretion of radio label arising from 14C-ETX2514 and to characterize metabolites of ETX2514 arising from 14C-ETX2514 administered intravenously in healthy participants. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Acinetobacter Baumannii-calcoaceticus Complex Infections | ||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: ETX2514 and 14C-ETX2514
Participants will receive a single intravenous infusion of 1 gram non-labeled ETX2514 and 1 microCurie (µCi) of 14C-ETX2514 in normal saline, administered as a 3-hour infusion.
Interventions:
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
8 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | July 26, 2019 | ||||
Actual Primary Completion Date | July 26, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 55 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04018950 | ||||
Other Study ID Numbers ICMJE | CS2514-2018-0002 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Entasis Therapeutics | ||||
Study Sponsor ICMJE | Entasis Therapeutics | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Entasis Therapeutics | ||||
Verification Date | August 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |