| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| 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 |
|---|---|
|
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 | |||||
|---|---|---|---|---|---|
| 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 |
|
||||
| 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 |
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