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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1316-0289 | Other Identifier | WHO |
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This is a Phase 1, multicenter, randomized, double-blind, double-dummy, single dose, placebo- and positive-controlled, 4-sequence, 4-treatment, 4-period crossover study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Balinatunfib Treatment A | Experimental | Participants will receive a single oral dose of balinatunfib. |
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| Balinatunfib Treatment B | Experimental | Participants will receive a single oral dose of balinatunfib. |
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| Moxifloxacin Treatment C | Active Comparator | Participants will receive a single oral dose of moxifloxacin. |
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| Placebo Treatment D | Placebo Comparator | Participants will receive a single oral dose of balinatunfib matching placebo and moxifloxacin matching placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Balinatunfib | Drug | Pharmaceutical form: Tablet Route of administration: Oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the QT interval corrected using the Fridericia formula (QTcF) centrally assessed using a semi-automatic reading | Baseline to day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in heart rate (HR) | Day 1 to Day 2 | |
| Change from baseline in QT interval | Baseline to day 2 of each period | |
| Change from baseline in QT interval corrected using the Bazett formula (QTcB) |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Both males and females aged 18-55 years are eligible, with at least 30% representation from each gender.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortrea Clinical Research Unit- Site Number : 8400002 | Dallas | Texas | 75247 | United States | ||
| Labcorp Clinical Research- Site Number : 8400001 |
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| Label | URL |
|---|---|
| TES18591 Plain Language Results Summary | View source |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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Williams design
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| Moxifloxacin | Drug | Pharmaceutical form: Tablet Route of administration: Oral |
|
| Placebo | Drug | Pharmaceutical form: Tablet Route of administration: Oral |
|
| Baseline to day 2 of each period |
| Change from baseline in population specific QT correction (QTcN) interval | Baseline to day 2 of each period |
| Change from baseline in QRS interval | Baseline to day 2 of each period |
| Change from baseline in PR interval | Baseline to day 2 of each period |
| Safety for electrocardiogram (ECG) parameters | Baseline to day 83 |
| Maximum plasma concentration (Cmax) for balinatunfib | Baseline to day 6 of each period |
| Time to reach the maximum concentration (tmax) for balinatunfib | Baseline to day 6 of each period |
| Area under the curve (AUC) for balinatunfib | Baseline to day 6 of each period |
| Maximum plasma concentration (Cmax) for balinatunfib metabolite M8 | Baseline to day 6 of each period |
| Time to reach the maximum concentration (tmax) for balinatunfib metabolite M8 | Baseline to day 6 of each period |
| Area under the curve (AUC) for balinatunfib metabolite M8 | Baseline to day 6 of each period |
| Number of participants experiencing treatment-emergent adverse events (TEAEs) including adverse events of special interest (AESIs) and serious adverse events (SAEs) | Baseline to Day 83 |
| Number of participants with clinical laboratory and vital signs abnormalities (potentially clinically significant abnormality) | Baseline to Day 83 |
| Madison |
| Wisconsin |
| 53704 |
| United States |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |