A Pilot Feasibility Study of Activated Charcoal in Healthy Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Feasibility Study of Activated Charcoal in Healthy Adult Volunteers

Conditions
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Healthy Adult Volunteers

Intervention / Treatment
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* Biological: Activated charcoal and Tap Water
* Biological: Activated Charcoal and Apple Juice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Solution A Dose 1, Then Solution B Dose 2<br>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<br>* 12 grams of AC mixed with Tap water or 25 grams of AC mixed with Tap water<br>* Other names: Medical grade AC, Activated Charcoal Powder, USP, activated carbon.;|
| Experimental: Solution A Dose 2, Then Solution B Dose 1<br>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<br>* 12 grams of AC mixed with Tap water or 25 grams of AC mixed with Tap water<br>* Other names: Medical grade AC, Activated Charcoal Powder, USP, activated carbon.;|
| Experimental: Solution B Dose 1, Then Solution A Dose 2<br>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<br>* 12 grams of AC with Apple Juice or 25 grams of AC with Apple Juice<br>|
| Experimental: Solution B Dose 2, Then Solution A Dose 1<br>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<br>* 12 grams of AC with Apple Juice or 25 grams of AC with Apple Juice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Grade 2 and Above Adverse Events Related to Activated Charcoal by Day 12 |  | 12 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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activated charcoal