A Pilot Feasibility Study of Activated Charcoal in Healthy Volunteers

University of Minnesota (UMN)

Status and phase: Completed; Early Phase 1

Conditions: Healthy Adult Volunteers

Treatments: Biological: Activated Charcoal and Apple Juice; Biological: Activated charcoal and Tap Water

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04204772

UL1TR002494 (U.S. NIH Grant/Contract)

2019LS014

HM2019-12 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 4 patient groups

Solution A Dose 1, Then Solution B Dose 2

Experimental group

Description:

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.

Treatment:

Biological: Activated charcoal and Tap Water

Solution A Dose 2, Then Solution B Dose 1

Experimental group

Description:

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.

Treatment:

Biological: Activated charcoal and Tap Water

Solution B Dose 1, Then Solution A Dose 2

Experimental group

Description:

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.

Treatment:

Biological: Activated Charcoal and Apple Juice

Solution B Dose 2, Then Solution A Dose 1

Experimental group

Description:

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.

Treatment:

Biological: Activated Charcoal and Apple Juice