Clinical trial NCT04204772: A Pilot Feasibility Study of Activated Charcoal in Healthy Volunteers
Official title: A Pilot Feasibility Study of Activated Charcoal in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy Adult Volunteers
Keywords: activated charcoal
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2019-12-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Average Palatability Rating
timeFrame: two weeks
Secondary outcomes:
measure: Number of Participants With Grade 2 and Above Adverse Events Related to Activated Charcoal by Day 12
timeFrame: 12 days
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center at University of Minnesota
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Armin Rashidi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: