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Completed

NCT Number: NCT04204772

A Pilot Feasibility Study of Activated Charcoal in Healthy Volunteers

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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Key information

Conditions

Healthy Adult Volunteers Anthrax Bacillaceae Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Activated charcoal and Tap Water

Biological

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

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

Activated Charcoal and Apple Juice

Biological

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

Primary outcomes

  1. Average Palatability Rating

    Time frame: 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 outcomes

  1. Number of Participants With Grade 2 and Above Adverse Events Related to Activated Charcoal by Day 12

    Time frame: 12 days

Sponsors and collaborators

Lead sponsor

Masonic Cancer Center, University of Minnesota

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

A Pilot Feasibility Study of Activated Charcoal in Healthy Adult Volunteers

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 19, 2019
Registry last updated
Oct 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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