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| ID | Type | Description | Link |
|---|---|---|---|
| HM2019-12 | Other Identifier | University of Minnesota Masonic Cancer Center | |
| UL1TR002494 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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This is a pilot study designed to test feasibility, tolerability, and safety of medical grade oral Activated Charcoal (AC) in 12 healthy volunteers. To determine the two most palatable and tolerable AC combinations. There will be a total of 4 combinations (2 AC doses and 2 solutions) in stage 1. Each participant will drink an assigned combination every day for 3 consecutive days (Monday, Tuesday, Wednesday, "M/T/W") and switch to a different assigned combination M/T/W the following week. AC solution assignments will be defined before the study using a balanced incomplete block design. Each subject will rate their experience using a 5-point scale every day for the 12 days they are on study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Solution A Dose 1, Then Solution B Dose 2 | Experimental | Participants initially assigned to Solution A Dose 1 will complete the three day course (days 1-3) and switch to the Solution B Dose 2 arm to complete the three day course (days 8-10). The dose level for Solution A Dose 1 is 12 grams of medical grade oral AC mixed with 4 ounces of tap water. Participants will report on a daily basis and consume the assigned combination of oral AC. |
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| Solution A Dose 2, Then Solution B Dose 1 | Experimental | Participants initially assigned to Solution A Dose 2 will complete the three day course (days 1-3) and switch to the Solution B Dose 1 arm to complete the three day course (days 8-10). The dose level for Solution A Dose 2 is 25 grams of medical grade oral AC mixed with 4 ounces of tap water. Participants will report on a daily basis and consume the assigned combination of oral AC. |
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| Solution B Dose 1, Then Solution A Dose 2 | Experimental | Participants initially assigned to Solution B Dose 1 will complete the three day course (days 1-3) and switch to the Solution A Dose 2 arm to complete the three day course (days 8-10). The dose level for Solution B Dose 1 is 12 grams of medical grade oral AC mixed with 4 ounces of apple juice. Participants will report on a daily basis and consume the assigned combination of oral AC. |
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| Solution B Dose 2, Then Solution A Dose 1 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Activated charcoal and Tap Water | Biological | 12 grams of AC mixed with Tap water or 25 grams of AC mixed with Tap water |
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| Measure | Description | Time Frame |
|---|---|---|
| Average Palatability Rating | Each healthy volunteer will rate their experience using a 5-point scale (1=terrible, 2=bad, 3=okay, 4=good, 5=great) every day. | two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Grade 2 and Above Adverse Events Related to Activated Charcoal by Day 12 | 12 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Armin Rashidi, MD, PhD | Masonic Cancer Center, University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masonic Cancer Center at University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
Participants were given dose assignments at the time of study registration using a balanced incomplete block design. One participant was assigned two out of the four possible solution-doses. Each participant will drink an assigned combination every day for 3 consecutive days (Monday, Tuesday, Wednesday, "M/T/W") and switch to a different assigned combination M/T/W the following week.
Healthy Volunteers will respond to poster advertisements containing a brief study description and the contact information of the study coordinator.
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| ID | Title | Description |
|---|---|---|
| FG000 | Solution A Dose 1, Then Solution B Dose 2 | Participants initially assigned to Solution A Dose 1 will complete the three day course (days 1-3) and switch to the Solution B Dose 2 arm to complete the three day course (days 8-10). The dose level for Solution A Dose 1 is 12 grams of medical grade oral AC mixed with 4 ounces of tap water. Participants will report on a daily basis and consume the assigned combination of oral AC. |
| FG001 | Solution A Dose 2, Then Solution B Dose 1 | Participants initially assigned to Solution A Dose 2 will complete the three day course (days 1-3) and switch to the Solution B Dose 1 arm to complete the three day course (days 8-10). The dose level for Solution A Dose 2 is 25 grams of medical grade oral AC mixed with 4 ounces of tap water. Participants will report on a daily basis and consume the assigned combination of oral AC. |
| FG002 | Solution B Dose 1, Then Solution A Dose 2 | Participants initially assigned to Solution B Dose 1 will complete the three day course (days 1-3) and switch to the Solution A Dose 2 arm to complete the three day course (days 8-10). The dose level for Solution B Dose 1 is 12 grams of medical grade oral AC mixed with 4 ounces of apple juice. Participants will report on a daily basis and consume the assigned combination of oral AC. |
| FG003 | Solution B Dose 2, Then Solution A Dose 1 | Participants initially assigned to Solution B Dose 2 will complete the three day course (days 1-3) and switch to the Solution A Dose 1 arm to complete the three day course (days 8-10). The dose level for Solution B Dose 2 is 25 grams of medical grade oral AC mixed with 4 ounces of apple juice. Participants will report on a daily basis and consume the assigned combination of oral AC. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Solution A Dose 1, Then Solution B Dose 2 | Participants initially assigned to Solution A Dose 1 will complete the three day course (days 1-3) and switch to the Solution B Dose 2 arm to complete the three day course (days 8-10). The dose level for Solution A Dose 1 is 12 grams of medical grade oral AC mixed with 4 ounces of tap water. Participants will report on a daily basis and consume the assigned combination of oral AC. |
| 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, Categorical | Count of Participants |
| 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 | Average Palatability Rating | Each healthy volunteer will rate their experience using a 5-point scale (1=terrible, 2=bad, 3=okay, 4=good, 5=great) every day. | Posted | Mean | Standard Deviation | score on a scale out of 5 | two weeks |
|
Participants were contacted during the first two weeks for any AEs.
Adverse events collected on a whole trial basis.
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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 | Solution A Dose 1 | Participants initially assigned to Solution A Dose 1 will complete the three day course (days 1-3) and switch to the Solution B Dose 2 arm to complete the three day course (days 8-10). The dose level for Solution A Dose 1 is 12 grams of medical grade oral AC mixed with 4 ounces of tap water. Participants will report on a daily basis and consume the assigned combination of oral AC. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdominal fullness/bloating | Gastrointestinal disorders | Non-systematic Assessment | AEs were all grade 1 and included abdominal fullness/bloating in 4 (33%) subjects, abdominal pain in 4 (33%) subjects, nausea in 2 (17%) subjects, constipation in 2 (17%) subjects, and diarrhea in 1 (8%) subject. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Armin Rashidi, MD, PhD | University of Minnesota, Department of Medicine | 612-624-0123 | arashidi@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 18, 2019 | Dec 14, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 21, 2020 | Jul 8, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000881 | Anthrax |
| ID | Term |
|---|---|
| D016863 | Bacillaceae Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D002606 | Charcoal |
| ID | Term |
|---|---|
| D002244 | Carbon |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
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12 healthy volunteers will be enrolled to determine the two most palatable and tolerable AC combinations. There will be a total of 4 combinations (2 AC doses and 2 solutions) in stage 1. Each participant will drink an assigned combination every day for 3 consecutive days (Monday, Tuesday, Wednesday, "M/T/W") and switch to a different assigned combination M/T/W the following week. AC solution assignments will be defined before the study using a balanced incomplete block design
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Participants initially assigned to Solution B Dose 2 will complete the three day course (days 1-3) and switch to the Solution A Dose 1 arm to complete the three day course (days 8-10). The dose level for Solution B Dose 2 is 25 grams of medical grade oral AC mixed with 4 ounces of apple juice. Participants will report on a daily basis and consume the assigned combination of oral AC.
|
|
| Activated Charcoal and Apple Juice | Biological | 12 grams of AC with Apple Juice or 25 grams of AC with Apple Juice |
|
| BG001 | Solution A Dose 2, Then Solution B Dose 1 | Participants initially assigned to Solution A Dose 2 will complete the three day course (days 1-3) and switch to the Solution B Dose 1 arm to complete the three day course (days 8-10). The dose level for Solution A Dose 2 is 25 grams of medical grade oral AC mixed with 4 ounces of tap water. Participants will report on a daily basis and consume the assigned combination of oral AC. |
| BG002 | Solution B Dose 1, Then Solution A Dose 2 | Participants initially assigned to Solution B Dose 1 will complete the three day course (days 1-3) and switch to the Solution A Dose 2 arm to complete the three day course (days 8-10). The dose level for Solution B Dose 1 is 12 grams of medical grade oral AC mixed with 4 ounces of apple juice. Participants will report on a daily basis and consume the assigned combination of oral AC. |
| BG003 | Solution B Dose 2, Then Solution A Dose 1 | Participants initially assigned to Solution B Dose 2 will complete the three day course (days 1-3) and switch to the Solution A Dose 1 arm to complete the three day course (days 8-10). The dose level for Solution B Dose 2 is 25 grams of medical grade oral AC mixed with 4 ounces of apple juice. Participants will report on a daily basis and consume the assigned combination of oral AC. |
| BG004 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG002 | Solution B Dose 1 | The dose level for Solution B Dose 1 is 12 grams of medical grade oral AC mixed with 4 ounces of apple juice. Participants will report on a daily basis and consume the assigned combination of oral AC. |
| OG003 | Solution B Dose 2 | The dose level for Solution B Dose 2 is 25 grams of medical grade oral AC mixed with 4 ounces of apple juice. Participants will report on a daily basis and consume the assigned combination of oral AC. |
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| Secondary | Number of Participants With Grade 2 and Above Adverse Events Related to Activated Charcoal by Day 12 | Adverse events analyzed on a per intervention basis. | Posted | Count of Participants | Participants | 12 days |
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| 0 |
| 6 |
| 0 |
| 6 |
| 3 |
| 6 |
| EG001 | Solution A Dose 2 | Participants initially assigned to Solution A Dose 2 will complete the three day course (days 1-3) and switch to the Solution B Dose 1 arm to complete the three day course (days 8-10). The dose level for Solution A Dose 2 is 25 grams of medical grade oral AC mixed with 4 ounces of tap water. Participants will report on a daily basis and consume the assigned combination of oral AC. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG002 | Solution B Dose 1 | Participants initially assigned to Solution B Dose 1 will complete the three day course (days 1-3) and switch to the Solution A Dose 2 arm to complete the three day course (days 8-10). The dose level for Solution B Dose 1 is 12 grams of medical grade oral AC mixed with 4 ounces of apple juice. Participants will report on a daily basis and consume the assigned combination of oral AC. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG003 | Solution B Dose 2 | Participants initially assigned to Solution B Dose 2 will complete the three day course (days 1-3) and switch to the Solution A Dose 1 arm to complete the three day course (days 8-10). The dose level for Solution B Dose 2 is 25 grams of medical grade oral AC mixed with 4 ounces of apple juice. Participants will report on a daily basis and consume the assigned combination of oral AC. | 0 | 6 | 0 | 6 | 3 | 6 |
|
| abdominal pain | Gastrointestinal disorders | Non-systematic Assessment | AEs were all grade 1 and included abdominal fullness/bloating in 4 (33%) subjects, abdominal pain in 4 (33%) subjects, nausea in 2 (17%) subjects, constipation in 2 (17%) subjects, and diarrhea in 1 (8%) subject. |
|
| nausea | General disorders | Non-systematic Assessment | AEs were all grade 1 and included abdominal fullness/bloating in 4 (33%) subjects, abdominal pain in 4 (33%) subjects, nausea in 2 (17%) subjects, constipation in 2 (17%) subjects, and diarrhea in 1 (8%) subject. |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment | AEs were all grade 1 and included abdominal fullness/bloating in 4 (33%) subjects, abdominal pain in 4 (33%) subjects, nausea in 2 (17%) subjects, constipation in 2 (17%) subjects, and diarrhea in 1 (8%) subject. |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment | AEs were all grade 1 and included abdominal fullness/bloating in 4 (33%) subjects, abdominal pain in 4 (33%) subjects, nausea in 2 (17%) subjects, constipation in 2 (17%) subjects, and diarrhea in 1 (8%) subject. |
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| Mild Throat Pain/dryness | General disorders | Non-systematic Assessment |
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| D007239 | Infections |
| Between 18 and 65 years |
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| >=65 years |
|
| Male |
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