Condition or disease | Intervention/treatment | Phase |
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Acinetobacter Baumannii-calcoaceticus Complex Infections | Drug: ETX2514 Drug: Placebo Drug: moxifloxacin | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 32 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Masking Description: | The administration of ETX2514 and ETX2514 placebo will be double-blinded. Placebo and moxifloxacin (Treatment Period C) will be administered open-label. |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Three Period Crossover Thorough QT (TQT) Study Evaluating the Effect of ETX2514 on Cardiac Repolarization in Healthy Male or Female Volunteers |
Actual Study Start Date : | May 23, 2019 |
Actual Primary Completion Date : | July 24, 2019 |
Actual Study Completion Date : | July 24, 2019 |
Arm | Intervention/treatment |
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Experimental: Treatment Sequence ABC
Participants will receive a single 3-hour intravenous (IV) infusion of 4 grams (g) of ETX2514 (supratherapeutic dose) (Treatment A), followed by a single 3-hour IV infusion of placebo for ETX2514 (Treatment B), followed by a single 3-hour IV infusion of placebo for ETX2514 and a single oral dose of 400 milligrams (mg) open-label moxifloxacin given at the end of the infusion (Treatment C). There will be 7 ± 2 days washout between treatments.
|
Drug: ETX2514
intravenous infusion
Drug: Placebo intravenous infusion
Drug: moxifloxacin oral tablet
|
Experimental: Treatment Sequence ACB
Participants will receive a single 3-hour IV infusion of 4 g of ETX2514 (supratherapeutic dose) (Treatment A), followed by a single 3-hour IV infusion of placebo for ETX2514 and a single oral dose of 400 mg open-label moxifloxacin given at the end of the infusion (Treatment C), followed by a single 3-hour IV infusion of placebo for ETX2514 (Treatment B). There will be 7 ± 2 days washout between treatments.
|
Drug: ETX2514
intravenous infusion
Drug: Placebo intravenous infusion
Drug: moxifloxacin oral tablet
|
Experimental: Treatment Sequence BAC
Participants will receive a single 3-hour IV infusion of placebo for ETX2514 (Treatment B), followed by a single 3-hour IV infusion of 4 g of ETX2514 (supratherapeutic dose) (Treatment A), followed by a single 3-hour IV infusion of placebo for ETX2514 and a single oral dose of 400 mg open-label moxifloxacin given at the end of the infusion (Treatment C). There will be 7 ± 2 days washout between treatments.
|
Drug: ETX2514
intravenous infusion
Drug: Placebo intravenous infusion
Drug: moxifloxacin oral tablet
|
Experimental: Treatment Sequence BCA
Participants will receive a single 3-hour IV infusion of placebo for ETX2514 (Treatment B), followed by a single 3-hour IV infusion of placebo for ETX2514 and a single oral dose of 400 mg open-label moxifloxacin given at the end of the infusion (Treatment C), followed by a single 3-hour IV infusion of 4 g of ETX2514 (supratherapeutic dose) (Treatment A). There will be 7 ± 2 days washout between treatments.
|
Drug: ETX2514
intravenous infusion
Drug: Placebo intravenous infusion
Drug: moxifloxacin oral tablet
|
Experimental: Treatment Sequence CAB
Participants will receive a single 3-hour IV infusion of placebo for ETX2514 and a single oral dose of 400 mg open-label moxifloxacin given at the end of the infusion (Treatment C), followed by a single 3-hour IV infusion of 4 g of ETX2514 (supratherapeutic dose) (Treatment A), followed by a single 3-hour IV infusion of placebo for ETX2514 (Treatment B). There will be 7 ± 2 days washout between treatments.
|
Drug: ETX2514
intravenous infusion
Drug: Placebo intravenous infusion
Drug: moxifloxacin oral tablet
|
Experimental: Treatment Sequence CBA
Participants will receive a single 3-hour IV infusion of placebo for ETX2514 and a single oral dose of 400 mg open-label moxifloxacin given at the end of the infusion (Treatment C), followed by a single 3-hour IV infusion of placebo for ETX2514 (Treatment B), followed by a single 3-hour IV infusion of 4 g of ETX2514 (supratherapeutic dose) (Treatment A). There will be 7 ± 2 days washout between treatments.
|
Drug: ETX2514
intravenous infusion
Drug: Placebo intravenous infusion
Drug: moxifloxacin oral tablet
|
Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
No clinically significant history or presence of ECG findings as judged by the PI at Screening and check-in, including each criterion as listed below:
Exclusion Criteria:
Unable to refrain from or anticipates the use of:
History or presence of:
repeated or frequent vasovagal episodes:
United States, Maryland | |
Pharmaron Clinical Pharmacology Center | |
Baltimore, Maryland, United States, 21201 |
Tracking Information | |||||
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First Submitted Date ICMJE | June 11, 2019 | ||||
First Posted Date ICMJE | June 13, 2019 | ||||
Last Update Posted Date | August 30, 2019 | ||||
Actual Study Start Date ICMJE | May 23, 2019 | ||||
Actual Primary Completion Date | July 24, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Placebo-corrected change from Baseline in Fridericia-corrected QTc (QTcF) (ΔΔQTcF) [ Time Frame: Baseline; up to Day 22 ] | ||||
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 Evaluating the Effect of ETX2514 on Cardiac Repolarization in Healthy Male or Female Volunteers | ||||
Official Title ICMJE | A Randomized, Three Period Crossover Thorough QT (TQT) Study Evaluating the Effect of ETX2514 on Cardiac Repolarization in Healthy Male or Female Volunteers | ||||
Brief Summary | This study is being conducted to evaluate the effects of supratherapeutic ETX2514 plasma concentrations on the heart rate-corrected QT interval (QTc). | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Masking Description: The administration of ETX2514 and ETX2514 placebo will be double-blinded. Placebo and moxifloxacin (Treatment Period C) will be administered 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 |
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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 |
32 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | July 24, 2019 | ||||
Actual Primary Completion Date | July 24, 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 | NCT03985410 | ||||
Other Study ID Numbers ICMJE | CS2514-2018-0003 | ||||
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 |