Healthy Adult Volunteers
Conditions
Keywords
activated charcoal
Brief summary
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.
Interventions
BIOLOGICALActivated charcoal and Tap Water
12 grams of AC mixed with Tap water or 25 grams of AC mixed with Tap water
BIOLOGICALActivated Charcoal and Apple Juice
12 grams of AC with Apple Juice or 25 grams of AC with Apple Juice
Sponsors
National Center for Advancing Translational Sciences (NCATS)
Masonic Cancer Center, University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age ≥18 years * No use of prescription medications, including oral birth control, currently or in the last 30 days * Sexually active women must be using an effective form of contraception. Note that subjects who are on oral contraception should use an additional form of contraception such as barrier methods, as AC may interfere with the efficacy of oral contraceptive * Voluntary written consent signed before performance of any study-related procedure
Exclusion criteria
* At risk of GI hemorrhage or perforation due to underlying pathology, recent surgery, or medical conditions that could be adversely affected by the administration of AC * Planning to have an endoscopic procedure * Known hypersensitivity to AC * Non-English speakers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Palatability Rating | two weeks | Each healthy volunteer will rate their experience using a 5-point scale (1=terrible, 2=bad, 3=okay, 4=good, 5=great) every day. |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Grade 2 and Above Adverse Events Related to Activated Charcoal by Day 12 | 12 days |
Countries
United States
Participant flow
Recruitment details
Healthy Volunteers will respond to poster advertisements containing a brief study description and the contact information of the study coordinator.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 3 |
| 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. | 3 |
| 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. | 3 |
| 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. | 3 |
| Total | 12 |
Baseline characteristics
| Characteristic | Total | Solution A Dose 2, Then Solution B Dose 1 | Solution B Dose 1, Then Solution A Dose 2 | Solution B Dose 2, Then Solution A Dose 1 | Solution A Dose 1, Then Solution B Dose 2 |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — | — | — |
| Region of Enrollment United States | 12 participants | 3 participants | 3 participants | 3 participants | 3 participants |
| Sex: Female, Male Female | 4 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Male | 8 Participants | 2 Participants | 2 Participants | 3 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 3 / 6 | 2 / 6 | 3 / 6 | 3 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
Outcome results
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.
Time frame: two weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Solution A Dose 1 | Average Palatability Rating | 3.5 score on a scale out of 5 | Standard Deviation 0.9 |
| Solution A Dose 2 | Average Palatability Rating | 4.0 score on a scale out of 5 | Standard Deviation 0.8 |
| Solution B Dose 1 | Average Palatability Rating | 4.9 score on a scale out of 5 | Standard Deviation 0.2 |
| Solution B Dose 2 | Average Palatability Rating | 4.4 score on a scale out of 5 | Standard Deviation 0.6 |
Secondary
Number of Participants With Grade 2 and Above Adverse Events Related to Activated Charcoal by Day 12
Time frame: 12 days
Population: Adverse events analyzed on a per intervention basis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Solution A Dose 1 | Number of Participants With Grade 2 and Above Adverse Events Related to Activated Charcoal by Day 12 | 0 Participants |
| Solution A Dose 2 | Number of Participants With Grade 2 and Above Adverse Events Related to Activated Charcoal by Day 12 | 0 Participants |
| Solution B Dose 1 | Number of Participants With Grade 2 and Above Adverse Events Related to Activated Charcoal by Day 12 | 0 Participants |
| Solution B Dose 2 | Number of Participants With Grade 2 and Above Adverse Events Related to Activated Charcoal by Day 12 | 0 Participants |