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NCT04204772 Clinical Trial

A Pilot Feasibility Study of Activated Charcoal in Healthy Volunteers

Healthy Adult Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04204772
Other study ID # 2019LS014
Secondary ID HM2019-12UL1TR00
Status Completed
Phase Early Phase 1
First received
Last updated
Start date January 22, 2020
Est. completion date March 31, 2021

Study information
Verified date October 2023
Source Masonic Cancer Center, University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date March 31, 2021
Est. primary completion date March 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Activated charcoal and Tap Water
12 grams of AC mixed with Tap water or 25 grams of AC mixed with Tap water
• Activated Charcoal and Apple Juice
12 grams of AC with Apple Juice or 25 grams of AC with Apple Juice

Locations
Country Name City State
United States Masonic Cancer Center at University of Minnesota Minneapolis Minnesota

Sponsors (2)
Lead Sponsor Collaborator
Masonic Cancer Center, University of Minnesota National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Number of Participants With Grade 2 and Above Adverse Events Related to Activated Charcoal by Day 12 12 days
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