A Pilot Feasibility Study of Activated Charcoal in Healthy Volunteers

A Pilot Feasibility Study of Activated Charcoal in Healthy Adult Volunteers

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.

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