Trial Outcomes & Findings for A Pilot Feasibility Study of Activated Charcoal in Healthy Volunteers (NCT NCT04204772)
NCT ID: NCT04204772
Last Updated: 2023-10-26
Results Overview
Each healthy volunteer will rate their experience using a 5-point scale (1=terrible, 2=bad, 3=okay, 4=good, 5=great) every day.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
12 participants
Primary outcome timeframe
two weeks
Results posted on
2023-10-26
Participant Flow
Healthy Volunteers will respond to poster advertisements containing a brief study description and the contact information of the study coordinator.
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Solution A Dose 1, Then Solution B Dose 2
n=3 Participants
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.
|
Solution A Dose 2, Then Solution B Dose 1
n=3 Participants
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.
|
Solution B Dose 1, Then Solution A Dose 2
n=3 Participants
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.
|
Solution B Dose 2, Then Solution A Dose 1
n=3 Participants
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.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=12 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
12 Participants
n=12 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=12 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
4 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=3 Participants
|
8 Participants
n=12 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
3 participants
n=3 Participants
|
3 participants
n=3 Participants
|
3 participants
n=3 Participants
|
3 participants
n=3 Participants
|
12 participants
n=12 Participants
|
PRIMARY outcome
Timeframe: two weeksEach healthy volunteer will rate their experience using a 5-point scale (1=terrible, 2=bad, 3=okay, 4=good, 5=great) every day.
Outcome measures
| Measure |
Solution A Dose 1
n=6 Participants
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.
|
Solution A Dose 2
n=6 Participants
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.
|
Solution B Dose 1
n=6 Participants
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.
|
Solution B Dose 2
n=6 Participants
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.
|
|---|---|---|---|---|
|
Average Palatability Rating
|
3.5 score on a scale out of 5
Standard Deviation 0.9
|
4.0 score on a scale out of 5
Standard Deviation 0.8
|
4.9 score on a scale out of 5
Standard Deviation 0.2
|
4.4 score on a scale out of 5
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: 12 daysPopulation: Adverse events analyzed on a per intervention basis.
Outcome measures
| Measure |
Solution A Dose 1
n=6 Participants
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.
|
Solution A Dose 2
n=6 Participants
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.
|
Solution B Dose 1
n=6 Participants
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.
|
Solution B Dose 2
n=6 Participants
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.
|
|---|---|---|---|---|
|
Number of Participants With Grade 2 and Above Adverse Events Related to Activated Charcoal by Day 12
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Solution A Dose 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Solution A Dose 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Solution B Dose 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Solution B Dose 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Solution A Dose 1
n=6 participants at risk
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.
|
Solution A Dose 2
n=6 participants at risk
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.
|
Solution B Dose 1
n=6 participants at risk
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.
|
Solution B Dose 2
n=6 participants at risk
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.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
abdominal fullness/bloating
|
16.7%
1/6 • Number of events 1 • Participants were contacted during the first two weeks for any AEs.
Adverse events collected on a whole trial basis.
|
0.00%
0/6 • Participants were contacted during the first two weeks for any AEs.
Adverse events collected on a whole trial basis.
|
16.7%
1/6 • Number of events 1 • Participants were contacted during the first two weeks for any AEs.
Adverse events collected on a whole trial basis.
|
33.3%
2/6 • Number of events 2 • Participants were contacted during the first two weeks for any AEs.
Adverse events collected on a whole trial basis.
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/6 • Participants were contacted during the first two weeks for any AEs.
Adverse events collected on a whole trial basis.
|
16.7%
1/6 • Number of events 1 • Participants were contacted during the first two weeks for any AEs.
Adverse events collected on a whole trial basis.
|
0.00%
0/6 • Participants were contacted during the first two weeks for any AEs.
Adverse events collected on a whole trial basis.
|
33.3%
2/6 • Number of events 2 • Participants were contacted during the first two weeks for any AEs.
Adverse events collected on a whole trial basis.
|
|
General disorders
nausea
|
16.7%
1/6 • Number of events 1 • Participants were contacted during the first two weeks for any AEs.
Adverse events collected on a whole trial basis.
|
0.00%
0/6 • Participants were contacted during the first two weeks for any AEs.
Adverse events collected on a whole trial basis.
|
16.7%
1/6 • Number of events 1 • Participants were contacted during the first two weeks for any AEs.
Adverse events collected on a whole trial basis.
|
0.00%
0/6 • Participants were contacted during the first two weeks for any AEs.
Adverse events collected on a whole trial basis.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Number of events 1 • Participants were contacted during the first two weeks for any AEs.
Adverse events collected on a whole trial basis.
|
0.00%
0/6 • Participants were contacted during the first two weeks for any AEs.
Adverse events collected on a whole trial basis.
|
16.7%
1/6 • Number of events 1 • Participants were contacted during the first two weeks for any AEs.
Adverse events collected on a whole trial basis.
|
0.00%
0/6 • Participants were contacted during the first two weeks for any AEs.
Adverse events collected on a whole trial basis.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/6 • Participants were contacted during the first two weeks for any AEs.
Adverse events collected on a whole trial basis.
|
0.00%
0/6 • Participants were contacted during the first two weeks for any AEs.
Adverse events collected on a whole trial basis.
|
0.00%
0/6 • Participants were contacted during the first two weeks for any AEs.
Adverse events collected on a whole trial basis.
|
16.7%
1/6 • Number of events 1 • Participants were contacted during the first two weeks for any AEs.
Adverse events collected on a whole trial basis.
|
|
General disorders
Mild Throat Pain/dryness
|
0.00%
0/6 • Participants were contacted during the first two weeks for any AEs.
Adverse events collected on a whole trial basis.
|
16.7%
1/6 • Number of events 1 • Participants were contacted during the first two weeks for any AEs.
Adverse events collected on a whole trial basis.
|
16.7%
1/6 • Number of events 1 • Participants were contacted during the first two weeks for any AEs.
Adverse events collected on a whole trial basis.
|
0.00%
0/6 • Participants were contacted during the first two weeks for any AEs.
Adverse events collected on a whole trial basis.
|
Additional Information
Armin Rashidi, MD, PhD
University of Minnesota, Department of Medicine
Phone: 612-624-0123
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place