A Pilot Feasibility Study of Activated Charcoal in Healthy Volunteers

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-22

Study Completion Date

2021-03-31

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.

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Detailed Description

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Conditions

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Healthy Adult Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Activated charcoal and Tap Water

Intervention Type BIOLOGICAL

12 grams of AC mixed with Tap water or 25 grams of AC mixed with Tap water

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.

Group Type EXPERIMENTAL

Activated charcoal and Tap Water

Intervention Type BIOLOGICAL

12 grams of AC mixed with Tap water or 25 grams of AC mixed with Tap water

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.

Group Type EXPERIMENTAL

Activated Charcoal and Apple Juice

Intervention Type BIOLOGICAL

12 grams of AC with Apple Juice or 25 grams of AC with Apple Juice

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.

Group Type EXPERIMENTAL

Activated Charcoal and Apple Juice

Intervention Type BIOLOGICAL

12 grams of AC with Apple Juice or 25 grams of AC with Apple Juice

Interventions

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Activated charcoal and Tap Water

12 grams of AC mixed with Tap water or 25 grams of AC mixed with Tap water

Intervention Type BIOLOGICAL

Activated Charcoal and Apple Juice

12 grams of AC with Apple Juice or 25 grams of AC with Apple Juice

Intervention Type BIOLOGICAL

Other Intervention Names

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Medical grade AC, "Activated Charcoal Powder, USP", activated carbon.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes