Early Phase 1
N=12
A Pilot Feasibility Study of Activated Charcoal in Healthy Volunteers
Healthy Adult Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT04204772 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Average Palatability Rating — 3.5; 4.0; 4.9; 4.4 score on a scale out of 5
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Activated charcoal and Tap Water (Biological); Activated Charcoal and Apple Juice (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Masonic Cancer Center, University of Minnesota
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Palatability Rating |
3.5; 4.0; 4.9; 4.4 | — |
| SECONDARY Number of Participants With Grade 2 and Above Adverse Events Related to Activated Charcoal by Day 12 |
0; 0; 0; 0 | — |
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
Data sourced from ClinicalTrials.gov (NCT04204772). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.