NCT04204772

A Pilot Feasibility Study of Activated Charcoal in Healthy Volunteers

A Pilot Feasibility Study of Activated Charcoal in Healthy Adult Volunteers

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	Activated charcoal and Tap Water	12 grams of AC mixed with Tap water or 25 grams of AC mixed with Tap water
BIOLOGICAL	Activated Charcoal and Apple Juice	12 grams of AC with Apple Juice or 25 grams of AC with Apple Juice

Timeline

• Start date: 2020-01-22
• Primary completion: 2021-03-31
• Completion: 2021-03-31
• First posted: 2019-12-19
• Last updated: 2023-10-26
• Results posted: 2023-10-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study