A Pilot Feasibility Study of Activated Charcoal in Healthy Volunteers

Early Phase 1CompletedNCT04204772

Masonic Cancer Center, University of Minnesota12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Healthy Adult Volunteers

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: two weeks

Secondary Outcomes

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

Time frame: 12 days