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| ID | Type | Description | Link |
|---|---|---|---|
| 701 (IMI WP8A ID #) | Other Identifier | The Medicines Company |
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| Name | Class |
|---|---|
| Universitätsklinikum Köln | OTHER |
| Innovative Medicines Initiative | OTHER |
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This was a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose study of the safety, tolerability, and pharmacokinetics of Minocin (minocycline) for injection in healthy adult participants.
The purpose of this study was to collect safety, tolerability, and pharmacokinetic (PK) data on ascending dose regimens of Minocin (minocycline) for Injection. The safety, tolerability, and PK data was to support the compound as a potential clinical candidate in Europe and allow recommendations of dose levels to be used in future Phase 2/3 studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minocin (minocycline) for Injection | Experimental | Minocin (minocycline) for Injection was supplied as a sterile lyophilized powder in single-use 10-milliliter (mL) glass vials. Each vial contained 108 milligrams (mg) of minocycline hydrochloride equivalent to 100 mg of minocycline. Each cohort received one of the following dosages of Minocin (minocycline) for Injection: 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, or 600 mg. Within each cohort, participants received a single dose on Day 1, followed by 7 days of multiple doses (Days 4 to 10, given every 12 hours), followed by a single dose on Day 11. |
|
| 0.9% Sodium Chloride Injection USP | Placebo Comparator | Placebo was in the form of the same 100-mL bags of normal saline (0.9% Sodium Chloride Injection United States Pharmacopeia [USP]). Dosing was on the same schedule as participants randomized to Minocin (minocycline) for Injection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minocin (minocycline) for Injection | Drug | Intravenous formulation of minocycline, a derivative of tetracycline |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number Of Participants Experiencing Treatment-emergent Adverse Events | Safety and tolerability of single and multiple intravenous doses of Minocin (minocycline) for Injection assessed by number of participants with adverse events. | Day 1 through Day 17 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Area Under The Concentration-time Curve From Zero Hours To The Last Measured Concentration (AUC0-t) After A Single Dose Of Minocin On Day 1 | Assessment of AUC0-t by cohort after a single intravenous dose of Minocin (minocycline) for Injection on Day 1 is reported as mg times hour/liter (mg*h/L). | Day 1 (Measurements taken at 1 [end of infusion], 2, 4, 8, 12, 18, 24, 36, 48, and 72 hours after the start of dosing) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Naguib Muhsen, MD | QPS Holdings LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| QPS | Groningen | AG | 9713 | Netherlands |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | 100 milligrams (mg) of Minocin (minocycline) for Injection on Day 1 then 100 mg every 12 hours on Days 4 to 10 and a single dose on Day 11 |
| FG001 | Cohort 2 | 200 mg of Minocin (minocycline) for Injection on Day 1 then 200 mg every 12 hours on Days 4 to 10 and a single dose on Day 11 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 9, 2017 | May 22, 2019 |
Model Description: Cohorts 1 and 2 were run concurrently as they were using the approved doses of intravenous minocycline in the United States. Cohorts 3, 4, 5 and 6 were run sequentially and only after review of data from the preceding cohorts by the data monitoring committee.
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| Placebo | Other | Placebo - Normal Saline |
|
| Assessment Of AUC0-t By Cohort After A Single Dose Of Minocin On Day 4 | Assessment of AUC0-t by cohort after a single dose of Minocin (minocycline) for Injection using plasma from serial blood samples on Day 4 is reported. | Day 4 (Measurements taken at 1 [end of infusion], 2, 4, 8, and 12 hours after the start of dosing) |
| Assessment Of AUC0-t By Cohort After Multiple Doses Of Minocin On Day 11 | Assessment of AUC0-t by cohort after 7 days of multiple doses of Minocin (minocycline) for Injection using plasma from serial blood samples on Day 11 is reported. | Day 11 (Measurements taken at 1 [end of infusion], 2, 4, 8, 12, 18, 24, 36, 48, and 72 hours after the start of dosing) |
| Assessment Of Maximum Plasma Concentration (Cmax) By Cohort For A Single Dose Of Minocin On Day 1 | Assessment of Cmax by cohort for a single intravenous dose of Minocin (minocycline) for Injection using serial blood samples on Day 1 is reported. | Day 1 (Measurements taken at 1 [end of infusion], 2, 4, 8, 12, 18, 24, 36, 48, and 72 hours after the start of dosing) |
| Assessment of Cmax by Cohort for a Single Dose of Minocin on Day 4 | Assessment of Cmax by cohort for a single intravenous dose of Minocin (minocycline) for Injection using serial blood samples on Day 4 is reported. | Day 4 (Measurements taken at 1 [end of infusion], 2, 4, 8, and 12 hours after the start of dosing) |
| Assessment Of Cmax By Cohort For Multiple Doses Of Minocin On Day 11 | Assessment of Cmax by cohort after 7 days of twice daily dosing of Minocin (minocycline) for Injection using serial blood samples on Day 11 is reported. | Day 11 (Measurements taken at 1 [end of infusion], 2, 4, 8, 12, 18, 24, 36, 48, and 72 hours after the start of dosing) |
| Assessment Of Apparent Terminal Elimination Half-life (T1/2) By Cohort For A Single Dose Of Minocin Using Plasma From Serial Blood Samples On Day 1 | Assessment of T1/2, defined by T1/2 = natural log of 2 divided by elimination constant (Kel) (T1/2), by cohort after a single intravenous dose of Minocin (minocycline) for Injection on Day 1 is reported. | Day 1 (Measurements taken at 1 [end of infusion], 2, 4, 8, 12, 18, 24, 36, 48, and 72 hours after the start of dosing) |
| Assessment Of T1/2 By Cohort After Multiple Doses Of Minocin Using Plasma From Serial Blood Samples On Day 11 | Assessment of T1/2, defined by T1/2 = natural log of 2 divided by Kel (T1/2), by cohort after 7 days of twice daily dosing of intravenous doses of Minocin (minocycline) for Injection on Day 11 is reported. | Day 11 (Measurements taken at 1 [end of infusion], 2, 4, 8, 12, 18, 24, 36, 48, and 72 hours after the start of dosing) |
| Assessment Of Amount Of Drug Excreted In Urine After A Single Dose Of Minocin Using Serial Urine Samples On Day 1 | Assessment of amount of drug excreted in urine after a single intravenous dose of Minocin (minocycline) for Injection using serial urine samples on Day 1 is reported. | Day 1 (Measurements collected from 0-4, 4-8, 8-12, 12-24, 24-48, and 48-72 hours after the start of dosing |
| Assessment Of Amount Of Drug Excreted In Urine After Multiple Intravenous Doses Of Minocin Using Serial Urine Samples On Day 11 | Assessment of amount of drug excreted in urine after 7 days of twice daily intravenous doses of Minocin (minocycline) for Injection using serial urine samples on Day 11 is reported. | Day 11 (Measurements collected from 0-4, 4-8, 8-12, 12-24, 24-48, and 48-72 hours after the start of dosing |
| Assessment Of Percent of Dose Excreted In Urine After A Single Dose Of Minocin Using Serial Urine Samples On Day 1 | Assessment of percent of dose excreted in urine after a single intravenous dose of Minocin (minocycline) for Injection using serial urine samples on Day 1 is reported. | Day 1 (Measurements collected from 0-4, 4-8, 8-12, 12-24, 24-48, and 48-72 hours after the start of dosing) |
| Assessment Of Percentage Of Drug Excreted In Urine After Multiple Intravenous Doses Of Minocin Using Serial Urine Samples On Day 11 | Assessment of percentage of drug excreted in urine after 7 days of twice daily intravenous doses of Minocin (minocycline) for Injection using serial urine samples on Day 11 is reported. | Day 11 (Measurements collected from 0-4, 4-8, 8-12, 12-24, 24-48, and 48-72 hours after the start of dosing |
| FG002 | Cohort 3 | 180 mg of Minocin (minocycline) for Injection on Day 1 then 300 mg every 12 hours on Day 4 Due to a dosing error, participants received doses of 180 mg instead of 300 mg as planned. The cohort was discontinued on Day 5 after detection of the dosing error and replaced by Cohort 3b. |
| FG003 | Cohort 3b | 300 mg of Minocin (minocycline) for Injection on Day 1 then 300 mg every 12 hours on Days 4 to 10 and a single dose on Day 11 Replacement of Cohort 3 |
| FG004 | Cohort 4 | 400 mg of Minocin (minocycline) for Injection on Day 1 then 400 mg every 12 hours on Days 4 to 7 and a single dose on Day 8 |
| FG005 | Cohort 5 | 500 mg of Minocin (minocycline) for Injection as a single dose on Day 1, 500 mg loading dose as the first dose on Day 4, 300 mg every 12 hours on Days 4 to 10 and as a single dose Day 11 |
| FG006 | Cohort 6 | 600 mg of Minocin (minocycline) for Injection as a single dose on Day 1, 600 mg loading dose as the first dose on Day 4, 300 mg every 12 hours Days 4 to 10 and as a single dose on Day 11 |
| FG007 | Placebo | Placebo was in the form of the same 100-milliliter (mL) bags of normal saline (0.9% Sodium Chloride Injection United States Pharmacopeia [USP]). Dosing was to the same schedule as participants randomized to Minocin (minocycline) for Injection. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | 100 mg of Minocin (minocycline) for Injection on Day 1 then 100 mg every 12 hours on Days 4 to 10 and a single dose on Day 11 |
| BG001 | Cohort 2 | 200 mg of Minocin (minocycline) for Injection on Day 1 then 200 mg every 12 hours on Days 4 to 10 and a single dose on Day 11 |
| BG002 | Cohort 3 | 180 mg of Minocin (minocycline) for Injection on Day 1 then 300 mg every 12 hours on Day 4 Due to a dosing error, participants received doses of 180 mg instead of 300 mg as planned. The cohort was discontinued on Day 5 after detection of the dosing error and replaced by Cohort 3b. |
| BG003 | Cohort 3b | 300 mg of Minocin (minocycline) for Injection on Day 1 then 300 mg every 12 hours on Days 4 to 10 and a single dose on Day 11 Replacement of Cohort 3 |
| BG004 | Cohort 4 | 400 mg of Minocin (minocycline) for Injection on Day 1 then 400 mg every 12 hours on Days 4 to 7 and a single dose on Day 8 |
| BG005 | Cohort 5 | 500 mg of Minocin (minocycline) for Injection as a single dose on Day 1, 500 mg loading dose as the first dose on Day 4, 300 mg every 12 hours on Days 4 to 10 and as a single dose Day 11 |
| BG006 | Cohort 6 | 600 mg of Minocin (minocycline) for Injection as a single dose on Day 1, 600 mg loading dose as the first dose on Day 4, 300 mg every 12 hours Days 4 to 10 and as a single dose on Day 11 |
| BG007 | Placebo | Placebo was in the form of the same 100-mL bags of normal saline (0.9% Sodium Chloride Injection USP). Dosing was to the same schedule as participants randomized to Minocin (minocycline) for Injection. |
| BG008 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index | Mean | Standard Deviation | kilogram/square meter |
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| Height | Mean | Standard Deviation | centimeter |
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| Weight | Mean | Standard Deviation | kilogram |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number Of Participants Experiencing Treatment-emergent Adverse Events | Safety and tolerability of single and multiple intravenous doses of Minocin (minocycline) for Injection assessed by number of participants with adverse events. | Safety Population: all enrolled participants who received at least 1 dose of study drug. | Posted | Number | participants | Day 1 through Day 17 |
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| Secondary | Assessment of Area Under The Concentration-time Curve From Zero Hours To The Last Measured Concentration (AUC0-t) After A Single Dose Of Minocin On Day 1 | Assessment of AUC0-t by cohort after a single intravenous dose of Minocin (minocycline) for Injection on Day 1 is reported as mg times hour/liter (mg*h/L). | Cohort 3 PK samples were not analyzed due to early termination of the cohort. The number of participants analyzed reflects the actual number of participants with PK measurements taken at Day 1. | Posted | Mean | Standard Deviation | mg*h/L | Day 1 (Measurements taken at 1 [end of infusion], 2, 4, 8, 12, 18, 24, 36, 48, and 72 hours after the start of dosing) |
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| Secondary | Assessment Of AUC0-t By Cohort After A Single Dose Of Minocin On Day 4 | Assessment of AUC0-t by cohort after a single dose of Minocin (minocycline) for Injection using plasma from serial blood samples on Day 4 is reported. | Cohort 3 PK samples were not analyzed due to early termination of the cohort. The number of participants analyzed reflects the actual number of participants with PK measurements taken at Day 4. | Posted | Mean | Standard Deviation | mg*h/L | Day 4 (Measurements taken at 1 [end of infusion], 2, 4, 8, and 12 hours after the start of dosing) |
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| Secondary | Assessment Of AUC0-t By Cohort After Multiple Doses Of Minocin On Day 11 | Assessment of AUC0-t by cohort after 7 days of multiple doses of Minocin (minocycline) for Injection using plasma from serial blood samples on Day 11 is reported. | Cohort 3 and Cohort 4 PK samples were not taken at Day 11 due to early termination of the cohorts. The number of participants analyzed reflects the actual number of participants with PK measurements taken at Day 11. | Posted | Mean | Standard Deviation | mg*h/L | Day 11 (Measurements taken at 1 [end of infusion], 2, 4, 8, 12, 18, 24, 36, 48, and 72 hours after the start of dosing) |
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| Secondary | Assessment Of Maximum Plasma Concentration (Cmax) By Cohort For A Single Dose Of Minocin On Day 1 | Assessment of Cmax by cohort for a single intravenous dose of Minocin (minocycline) for Injection using serial blood samples on Day 1 is reported. | Cohort 3 PK samples were not analyzed due to early termination of cohort. The number of participants analyzed reflects the number of participants who had plasma PK samples taken at Day 1. | Posted | Mean | Standard Deviation | mg/L | Day 1 (Measurements taken at 1 [end of infusion], 2, 4, 8, 12, 18, 24, 36, 48, and 72 hours after the start of dosing) |
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| Secondary | Assessment of Cmax by Cohort for a Single Dose of Minocin on Day 4 | Assessment of Cmax by cohort for a single intravenous dose of Minocin (minocycline) for Injection using serial blood samples on Day 4 is reported. | Cohort 3 PK samples were not analyzed due to early termination of the cohort. The number of participants analyzed reflects the actual number of participants with PK measurements taken at Day 4. | Posted | Mean | Standard Deviation | mg/L | Day 4 (Measurements taken at 1 [end of infusion], 2, 4, 8, and 12 hours after the start of dosing) |
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| Secondary | Assessment Of Cmax By Cohort For Multiple Doses Of Minocin On Day 11 | Assessment of Cmax by cohort after 7 days of twice daily dosing of Minocin (minocycline) for Injection using serial blood samples on Day 11 is reported. | Cohort 3 and Cohort 4 PK samples were not taken at Day 11 due to early termination of the cohorts. The number of participants analyzed reflects the actual number of participants with PK measurements taken at Day 11. | Posted | Mean | Standard Deviation | mg/L | Day 11 (Measurements taken at 1 [end of infusion], 2, 4, 8, 12, 18, 24, 36, 48, and 72 hours after the start of dosing) |
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| Secondary | Assessment Of Apparent Terminal Elimination Half-life (T1/2) By Cohort For A Single Dose Of Minocin Using Plasma From Serial Blood Samples On Day 1 | Assessment of T1/2, defined by T1/2 = natural log of 2 divided by elimination constant (Kel) (T1/2), by cohort after a single intravenous dose of Minocin (minocycline) for Injection on Day 1 is reported. | Cohort 3 PK samples were not analyzed due to early termination of the cohort. The number of participants analyzed reflects the actual number of participants with PK measurements taken at Day 1. | Posted | Mean | Standard Deviation | h | Day 1 (Measurements taken at 1 [end of infusion], 2, 4, 8, 12, 18, 24, 36, 48, and 72 hours after the start of dosing) |
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| Secondary | Assessment Of T1/2 By Cohort After Multiple Doses Of Minocin Using Plasma From Serial Blood Samples On Day 11 | Assessment of T1/2, defined by T1/2 = natural log of 2 divided by Kel (T1/2), by cohort after 7 days of twice daily dosing of intravenous doses of Minocin (minocycline) for Injection on Day 11 is reported. | Cohort 3 and Cohort 4 PK samples were not taken at Day 11 due to early termination of the cohorts. The number of participants analyzed reflects the actual number of participants with PK measurements taken at Day 11. | Posted | Mean | Standard Deviation | h | Day 11 (Measurements taken at 1 [end of infusion], 2, 4, 8, 12, 18, 24, 36, 48, and 72 hours after the start of dosing) |
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| Secondary | Assessment Of Amount Of Drug Excreted In Urine After A Single Dose Of Minocin Using Serial Urine Samples On Day 1 | Assessment of amount of drug excreted in urine after a single intravenous dose of Minocin (minocycline) for Injection using serial urine samples on Day 1 is reported. | Cohort 3 PK samples were not analyzed due to early termination of the cohort. The number of participants analyzed reflects the actual number of participants with PK measurements taken at Day 1. | Posted | Mean | Standard Deviation | L/h | Day 1 (Measurements collected from 0-4, 4-8, 8-12, 12-24, 24-48, and 48-72 hours after the start of dosing |
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| Secondary | Assessment Of Amount Of Drug Excreted In Urine After Multiple Intravenous Doses Of Minocin Using Serial Urine Samples On Day 11 | Assessment of amount of drug excreted in urine after 7 days of twice daily intravenous doses of Minocin (minocycline) for Injection using serial urine samples on Day 11 is reported. | Cohort 3 and Cohort 4 PK samples were not taken at Day 11 at Day 11 due to early termination of the cohorts. The number of participants analyzed reflects the actual number of participants with urine samples taken at Day 11. | Posted | Mean | Standard Deviation | L/hr | Day 11 (Measurements collected from 0-4, 4-8, 8-12, 12-24, 24-48, and 48-72 hours after the start of dosing |
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| Secondary | Assessment Of Percent of Dose Excreted In Urine After A Single Dose Of Minocin Using Serial Urine Samples On Day 1 | Assessment of percent of dose excreted in urine after a single intravenous dose of Minocin (minocycline) for Injection using serial urine samples on Day 1 is reported. | Cohort 3 PK samples were not analyzed due to early termination of the cohort. The number of participants analyzed reflects the actual number of participants with PK measurements taken at Day 1. | Posted | Mean | Standard Deviation | percentage of dose | Day 1 (Measurements collected from 0-4, 4-8, 8-12, 12-24, 24-48, and 48-72 hours after the start of dosing) |
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| Secondary | Assessment Of Percentage Of Drug Excreted In Urine After Multiple Intravenous Doses Of Minocin Using Serial Urine Samples On Day 11 | Assessment of percentage of drug excreted in urine after 7 days of twice daily intravenous doses of Minocin (minocycline) for Injection using serial urine samples on Day 11 is reported. | Cohort 3 and Cohort 4 PK samples were not taken at Day 11 due to early termination of the cohorts. The number of participants analyzed reflects the actual number of participants with urine PK samples taken at Day 11. | Posted | Mean | Standard Deviation | Percentage of dose | Day 11 (Measurements collected from 0-4, 4-8, 8-12, 12-24, 24-48, and 48-72 hours after the start of dosing |
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All AEs occurring from the time when first dose was administered (Day 1) up to the last follow-up visit (Day 17).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 | 100 mg of Minocin (minocycline) for Injection on Day 1 then 100 mg every 12 hours on Days 4 to 10 and a single dose on Day 11 | 0 | 8 | 0 | 8 | 6 | 8 |
| EG001 | Cohort 2 | 200 mg of Minocin (minocycline) for Injection on Day 1 then 200 mg every 12 hours on Days 4 to 10 and a single dose on Day 11 | 0 | 8 | 0 | 8 | 8 | 8 |
| EG002 | Cohort 3 | 180 mg of Minocin (minocycline) for Injection on Day 1 then 300 mg every 12 hours on Day 4 Due to a dosing error, participants received doses of 180 mg instead of 300 mg as planned. The cohort was discontinued on Day 5 after detection of the dosing error and replaced by Cohort 3b. | 0 | 6 | 0 | 6 | 4 | 6 |
| EG003 | Cohort 3b | 300 mg of Minocin (minocycline) for Injection on Day 1 then 300 mg every 12 hours on Days 4 to 10 and a single dose on Day 11 Replacement of Cohort 3 | 0 | 8 | 0 | 8 | 8 | 8 |
| EG004 | Cohort 4 | 400 mg of Minocin (minocycline) for Injection on Day 1 then 400 mg every 12 hours on Days 4 to 7 and a single dose on Day 8 | 0 | 8 | 0 | 8 | 8 | 8 |
| EG005 | Cohort 5 | 500 mg of Minocin (minocycline) for Injection as a single dose on Day 1, 500 mg loading dose as the first dose on Day 4, 300 mg every 12 hours on Days 4 to 10 and as a single dose Day 11 | 0 | 8 | 0 | 8 | 8 | 8 |
| EG006 | Cohort 6 | 600 mg of Minocin (minocycline) for Injection as a single dose on Day 1, 600 mg loading dose as the first dose on Day 4, 300 mg every 12 hours Days 4 to 10 and as a single dose on Day 11 | 0 | 9 | 0 | 9 | 9 | 9 |
| EG007 | Placebo | Placebo was in the form of the same 100-mL bags of normal saline (0.9% Sodium Chloride Injection USP). Dosing was to the same schedule as participants randomized to Minocin (minocycline) for Injection. | 0 | 14 | 0 | 14 | 12 | 14 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Infusion site reaction | General disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Dizziness postural | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Catheter site related reaction | General disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Infusion site pain | General disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Diplopia | Eye disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Eyelid oedema | Eye disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Lacrimation increased | Eye disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Paraesthesia oral | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Catheter site pain | General disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Chest pain | General disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Chills | General disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Feeling cold | General disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Feeling hot | General disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
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| Body temperature increased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Jaw disorder | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Balance disorder | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Coordination abnormal | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Disturbance in attention | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Hypogeusia | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Mood altered | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
| |
| Substance use | Social circumstances | MedDRA 20.0 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information | Melinta Therapeutics, LLC | 1-844-633-6568 | medinfo@melinta.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 23, 2018 | May 22, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D008911 | Minocycline |
| D000074584 | WW Domain-Containing Oxidoreductase |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000074583 | Short Chain Dehydrogenase-Reductases |
| D064430 | NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases |
| D000429 | Alcohol Oxidoreductases |
| D010088 | Oxidoreductases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D025521 | Tumor Suppressor Proteins |
| D009363 | Neoplasm Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Serious Adverse Events |
|
| Adverse Event Leading to Withdrawal from Treatment |
|
| Participants With Any Adverse Event |
|
| Participants With Any Adverse Events During Single Dose |
|
| Participants With Any Adverse Event During Multiple Doses |
|
| OG003 | Cohort 4 | 400 mg of Minocin (minocycline) for Injection on Day 1 then 400 mg every 12 hours on Days 4 to 7 and a single dose on Day 8 |
| OG004 | Cohort 5 | 500 mg of Minocin (minocycline) for Injection as a single dose on Day 1, 500 mg loading dose as the first dose on Day 4, 300 mg every 12 hours on Days 4 to 10 and as a single dose Day 11 |
| OG005 | Cohort 6 | 600 mg of Minocin (minocycline) for Injection as a single dose on Day 1, 600 mg loading dose as the first dose on Day 4, 300 mg every 12 hours Days 4 to 10 and as a single dose on Day 11 |
|
|
400 mg of Minocin (minocycline) for Injection on Day 1 then 400 mg every 12 hours on Days 4 to 7 and a single dose on Day 8 |
| OG004 | Cohort 5 | 500 mg of Minocin (minocycline) for Injection as a single dose on Day 1, 500 mg loading dose as the first dose on Day 4, 300 mg every 12 hours on Days 4 to 10 and as a single dose Day 11 |
| OG005 | Cohort 6 | 600 mg of Minocin (minocycline) for Injection as a single dose on Day 1, 600 mg loading dose as the first dose on Day 4, 300 mg every 12 hours Days 4 to 10 and as a single dose on Day 11 |
|
|
| Cohort 5 |
500 mg of Minocin (minocycline) for Injection as a single dose on Day 1, 500 mg loading dose as the first dose on Day 4, 300 mg every 12 hours on Days 4 to 10 and as a single dose Day 11 |
| OG004 | Cohort 6 | 600 mg of Minocin (minocycline) for Injection as a single dose on Day 1, 600 mg loading dose as the first dose on Day 4, 300 mg every 12 hours Days 4 to 10 and as a single dose on Day 11 |
|
|
| Cohort 4 |
400 mg of Minocin (minocycline) for Injection on Day 1 then every 400 mg 12 hours on Days 4 to 7 and a single dose on Day 8 |
| OG004 | Cohort 5 | 500 mg of Minocin (minocycline) for Injection as a single dose on Day 1, 500 mg loading dose as the first dose on Day 4, 300 mg every 12 hours on Days 4 to 10 and as a single dose Day 11 |
| OG005 | Cohort 6 | 600 mg of Minocin (minocycline) for Injection as a single dose on Day 1, 600 mg loading dose as the first dose on Day 4, 300 mg every 12 hours Days 4 to 10 and as a single dose on Day 11 |
|
|
400 mg of Minocin (minocycline) for Injection on Day 1 then 400 mg every 12 hours on Days 4 to 7 and a single dose on Day 8 |
| OG004 | Cohort 5 | 500 mg of Minocin (minocycline) for Injection as a single dose on Day 1, 500 mg loading dose as the first dose on Day 4, 300 mg every 12 hours on Days 4 to 10 and as a single dose Day 11 |
| OG005 | Cohort 6 | 600 mg of Minocin (minocycline) for Injection as a single dose on Day 1, 600 mg loading dose as the first dose on Day 4, 300 mg every 12 hours Days 4 to 10 and as a single dose on Day 11 |
|
|
| Cohort 5 |
500 mg of Minocin (minocycline) for Injection as a single dose on Day 1, 500 mg loading dose as the first dose on Day 4, 300 mg every 12 hours on Days 4 to 10 and as a single dose Day 11 |
| OG004 | Cohort 6 | 600 mg of Minocin (minocycline) for Injection as a single dose on Day 1, 600 mg loading dose as the first dose on Day 4, 300 mg every 12 hours Days 4 to 10 and as a single dose on Day 11 |
|
|
| OG003 | Cohort 4 | 400 mg of Minocin (minocycline) for Injection on Day 1 then 400 mg every12 hours on Days 4 to 7 and a single dose on Day 8 |
| OG004 | Cohort 5 | 500 mg of Minocin (minocycline) for Injection as a single dose on Day 1, 500 mg loading dose as the first dose on Day 4, 300 mg every 12 hours on Days 4 to 10 and as a single dose Day 11 |
| OG005 | Cohort 6 | 600 mg of Minocin (minocycline) for Injection as a single dose on Day 1, 600 mg loading dose as the first dose on Day 4, 300 mg every 12 hours Days 4 to 10 and as a single dose on Day 11 |
|
|
| OG003 | Cohort 5 | 500 mg of Minocin (minocycline) for Injection as a single dose on Day 1, 500 mg loading dose as the first dose on Day 4, 300 mg every 12 hours on Days 4 to 10 and as a single dose Day 11 |
| OG004 | Cohort 6 | 600 mg of Minocin (minocycline) for Injection as a single dose on Day 1, 600 mg loading dose as the first dose on Day 4, 300 mg every 12 hours Days 4 to 10 and as a single dose on Day 11 |
|
|
| OG003 |
| Cohort 4 |
400 mg of Minocin (minocycline) for Injection on Day 1 then 400 mg every 12 hours on Days 4 to 7 and a single dose on Day 8 |
| OG004 | Cohort 5 | 500 mg of Minocin (minocycline) for Injection as a single dose on Day 1, 500 mg loading dose as the first dose on Day 4, 300 mg every 12 hours on Days 4 to 10 and as a single dose Day 11 |
| OG005 | Cohort 6 | 600 mg of Minocin (minocycline) for Injection as a single dose on Day 1, 600 mg loading dose as the first dose on Day 4, 300 mg every 12 hours Days 4 to 10 and as a single dose on Day 11 |
|
|
| OG003 | Cohort 5 | 500 mg of Minocin (minocycline) for Injection as a single dose on Day 1, 500 mg loading dose as the first dose on Day 4, 300 mg every 12 hours on Days 4 to 10 and as a single dose Day 11 |
| OG004 | Cohort 6 | 600 mg of Minocin (minocycline) for Injection as a single dose on Day 1, 600 mg loading dose as the first dose on Day 4, 300 mg every 12 hours Days 4 to 10 and as a single dose on Day 11 |
|
|
| OG003 |
| Cohort 4 |
400 mg of Minocin (minocycline) for Injection on Day 1 then 400 mg every 12 hours on Days 4 to 7 and a single dose on Day 8 |
| OG004 | Cohort 5 | 500 mg of Minocin (minocycline) for Injection as a single dose on Day 1, 500 mg loading dose as the first dose on Day 4, 300 mg every 12 hours Days 4 to 10 and as a single dose on Day 11 |
| OG005 | Cohort 6 | 600 mg of Minocin (minocycline) for Injection as a single dose on Day 1, 600 mg loading dose as the first dose on Day 4, 300 mg every 12 hours Days 4 to 10 and as a single dose on Day 11 |
|
|
| OG003 | Cohort 5 | 500 mg of Minocin (minocycline) for Injection as a single dose on Day 1, 500 mg loading dose as the first dose on Day 4, 300 mg every 12 hours on Days 4 to 10 and as a single dose Day 11 |
| OG004 | Cohort 6 | 600 mg of Minocin (minocycline) for Injection as a single dose on Day 1, 600 mg loading dose as the first dose on Day 4, 300 mg every 12 hours Days 4 to 10 and as a single dose on Day 11 |
|
|