A Pilot Feasibility Study of Activated Charcoal in Healthy Volunteers

NCT04204772 | Completed Early Phase 1 Results FDA Drug

• 3 other identifiers: 2019LS014HM2019-12UL1TR002494
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Adult Volunteers

Keywords

activated charcoal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  12 days

Study Arms (4)

Solution A Dose 1, Then Solution B Dose 2

EXPERIMENTAL

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

Solution A Dose 2, Then Solution B Dose 1

EXPERIMENTAL

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

Solution B Dose 1, Then Solution A Dose 2

EXPERIMENTAL

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

Solution B Dose 2, Then Solution A Dose 1

EXPERIMENTAL

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

Interventions

Activated charcoal and Tap Water BIOLOGICAL

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.

Solution A Dose 1, Then Solution B Dose 2; Solution A Dose 2, Then Solution B Dose 1

Activated Charcoal and Apple Juice BIOLOGICAL

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

Solution B Dose 1, Then Solution A Dose 2; Solution B Dose 2, Then Solution A Dose 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Anthrax

Interventions

Charcoal

Condition Hierarchy (Ancestors)

Bacillaceae Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Carbon; Elements; Inorganic Chemicals

Results Point of Contact

• Title: Armin Rashidi, MD, PhD
• Organization: University of Minnesota, Department of Medicine

arashidi@umn.edu

612-624-0123

Study Officials

• Armin Rashidi, MD, PhD

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 19, 2019
• Study Start: January 22, 2020
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: October 26, 2023
• Results First Posted: October 26, 2023

Record last verified: 2023-10

Locations

US (1)