An Early Phase 1 interventional study of Activated charcoal and Tap Water and Activated Charcoal and Apple Juice in Healthy Adult Volunteers, sponsored by Masonic Cancer Center, University of Minnesota. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-26.
Sponsored by Masonic Cancer Center, University of Minnesota · Early Phase 1, Interventional, and Supportive care
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.
Masonic Cancer Center, University of Minnesota is the lead sponsor of 284 studies on the registry; 34 are open to participants now.
Of its 39 completed or terminated interventional studies of FDA-regulated products, 28 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Biological: Activated charcoal and Tap Water
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.
Biological: Activated charcoal and Tap Water
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.
Biological: Activated Charcoal and Apple Juice
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.
Biological: Activated Charcoal and Apple Juice
12 grams of AC mixed with Tap water or 25 grams of AC mixed with Tap water
Also known as: Medical grade AC, "Activated Charcoal Powder, USP", activated carbon.
12 grams of AC with Apple Juice or 25 grams of AC with Apple Juice
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
Number of Participants With Grade 2 and Above Adverse Events Related to Activated Charcoal by Day 12
Time frame: 12 days
Healthy Volunteers will respond to poster advertisements containing a brief study description and the contact information of the study coordinator.
| Milestone | Solution A Dose 1, Then Solution B Dose 2 | 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 |
|---|---|---|---|---|
| Started | 3 | 3 | 3 | 3 |
| Completed | 3 | 3 | 3 | 3 |
| Not completed | 0 | 0 | 0 | 0 |
Each healthy volunteer will rate their experience using a 5-point scale (1=terrible, 2=bad, 3=okay, 4=good, 5=great) every day.
| score on a scale out of 5 | Solution A Dose 1 | Solution A Dose 2 | Solution B Dose 1 | Solution B Dose 2 |
|---|---|---|---|---|
| Average Palatability Rating | 3.5 ± 0.9 | 4.0 ± 0.8 | 4.9 ± 0.2 | 4.4 ± 0.6 |
| Participants | Solution A Dose 1 | Solution A Dose 2 | Solution B Dose 1 | Solution B Dose 2 |
|---|---|---|---|---|
| Number of Participants With Grade 2 and Above Adverse Events Related to Activated Charcoal by Day 12 | 0 | 0 | 0 | 0 |
Collected over Participants were contacted during the first two weeks for any AEs.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Solution A Dose 1 | 0/6 (0%) | 0/6 (0%) | 3/6 (50%) |
| Solution A Dose 2 | 0/6 (0%) | 0/6 (0%) | 2/6 (33.3%) |
| Solution B Dose 1 | 0/6 (0%) | 0/6 (0%) | 3/6 (50%) |
| Solution B Dose 2 | 0/6 (0%) | 0/6 (0%) | 3/6 (50%) |
| Event | Solution A Dose 1 | Solution A Dose 2 | Solution B Dose 1 | Solution B Dose 2 |
|---|---|---|---|---|
| abdominal fullness/bloatingGastrointestinal disorders | 1/6 | 0/6 | 1/6 | 2/6 |
| abdominal painGastrointestinal disorders | 0/6 | 1/6 | 0/6 | 2/6 |
| nauseaGeneral disorders | 1/6 | 0/6 | 1/6 | 0/6 |
| ConstipationGastrointestinal disorders | 1/6 | 0/6 | 1/6 | 0/6 |
| DiarrheaGastrointestinal disorders | 0/6 | 0/6 | 0/6 | 1/6 |
| Mild Throat Pain/drynessGeneral disorders | 0/6 | 1/6 | 1/6 | 0/6 |
| Age, Categorical(Participants) | Solution A Dose 1, Then Solution B Dose 2 | 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 | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 3 | 3 | 3 | 12 |
| >=65 years | 0 | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Solution A Dose 1, Then Solution B Dose 2 | 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 | Total |
|---|---|---|---|---|---|
| Female | 2 | 1 | 1 | 0 | 4 |
| Male | 1 | 2 | 2 | 3 | 8 |
| Race and Ethnicity Not Collected(Participants) | Solution A Dose 1, Then Solution B Dose 2 | 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 | Total |
|---|---|---|---|---|---|
| Count of participants | — | — | — | — | 0 |
| Region of Enrollment(participants) | Solution A Dose 1, Then Solution B Dose 2 | 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 | Total |
|---|---|---|---|---|---|
| United States | 3 | 3 | 3 | 3 | 12 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Masonic Cancer Center, University of Minnesota