Healthy Adult VolunteersEarly Phase 1NCT04204772

A Pilot Feasibility Study of Activated Charcoal in Healthy Volunteers

A Early Phase 1 study testing Activated charcoal and Tap Water and Activated Charcoal and Apple Juice in people with Healthy Adult Volunteers, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy Adult Volunteers
What is being tested?: Activated charcoal and Tap Water and Activated Charcoal and Apple Juice
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: 22 Jan 2020to 31 Mar 2021
Phase: Early Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, 55455

Other trials in United States

About this study

Official title: 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.

Conditions: Healthy Adult Volunteers
Being tested: Activated charcoal and Tap Water, Activated Charcoal and Apple Juice
Keywords: activated charcoal
Medical subject headings: Anthrax

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Activated charcoal and Tap WaterBiological
Also called Medical grade AC, "Activated Charcoal Powder, USP", activated carbon.
12 grams of AC mixed with Tap water or 25 grams of AC mixed with Tap water
Activated Charcoal and Apple JuiceBiological
12 grams of AC with Apple Juice or 25 grams of AC with Apple Juice

Study groups in NCT04204772
Study group	Role	What they receive
Solution A Dose 1, Then Solution B Dose 2	Experimental	Participants initially assigned to Solution A Dose 1 will complete the three day course (days 1-3) and switch to the Solution B Dose 2 arm to complete the three day course (days 8-10). The dose level for Solution A Dose 1 is 12 grams of medical grade oral AC mixed with 4 ounces of tap water. Participants will report on a daily basis and consume the assigned combination of oral AC. Receives: Biological: Activated charcoal and Tap Water
Solution A Dose 2, Then Solution B Dose 1	Experimental	Participants initially assigned to Solution A Dose 2 will complete the three day course (days 1-3) and switch to the Solution B Dose 1 arm to complete the three day course (days 8-10). The dose level for Solution A Dose 2 is 25 grams of medical grade oral AC mixed with 4 ounces of tap water. Participants will report on a daily basis and consume the assigned combination of oral AC. Receives: Biological: Activated charcoal and Tap Water
Solution B Dose 1, Then Solution A Dose 2	Experimental	Participants initially assigned to Solution B Dose 1 will complete the three day course (days 1-3) and switch to the Solution A Dose 2 arm to complete the three day course (days 8-10). The dose level for Solution B Dose 1 is 12 grams of medical grade oral AC mixed with 4 ounces of apple juice. Participants will report on a daily basis and consume the assigned combination of oral AC. Receives: Biological: Activated Charcoal and Apple Juice
Solution B Dose 2, Then Solution A Dose 1	Experimental	Participants initially assigned to Solution B Dose 2 will complete the three day course (days 1-3) and switch to the Solution A Dose 1 arm to complete the three day course (days 8-10). The dose level for Solution B Dose 2 is 25 grams of medical grade oral AC mixed with 4 ounces of apple juice. Participants will report on a daily basis and consume the assigned combination of oral AC. Receives: Biological: Activated Charcoal and Apple Juice

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: two weeks

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jan 202031 Mar 2021

First posted19 Dec 2019
Study start22 Jan 2020
Primary completion31 Mar 2021
Study completion31 Mar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy Adult VolunteersStudies of the same condition, open and under way.
More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
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
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04204772
Sponsor's protocol ID: 2019LS014
Other IDs: HM2019-12, UL1TR002494
Status last verified: Oct 2023
First submitted: 17 Dec 2019
Last updated: 26 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy Adult Volunteers trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Feasibility Study of Activated Charcoal in Healthy Adult Volunteers
ClinicalTrials.gov ID: NCT04204772
Acronym / sponsor ID: 2019LS014
Conditions: Healthy Adult Volunteers
Keywords: activated charcoal
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
Collaborators: National Center for Advancing Translational Sciences (NCATS)
Study start: 22 Jan 2020 (actual)
Primary completion: 31 Mar 2021 (actual)
Study completion: 31 Mar 2021 (actual)
First posted: 19 Dec 2019 (actual)
Results: Posted 26 Oct 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4
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

Arm	Type	Receives
Solution A Dose 1, Then Solution B Dose 2	Experimental	Biological: Activated charcoal and Tap WaterParticipants initially assigned to Solution A Dose 1 will complete the three day course (days 1-3) and switch to the Solution B Dose 2 arm to complete the three day course (days 8-10). The dose level for Solution A Dose 1 is 12 grams of medical grade oral AC mixed with 4 ounces of tap water. Participants will report on a daily basis and consume the assigned combination of oral AC.
Solution A Dose 2, Then Solution B Dose 1	Experimental	Biological: Activated charcoal and Tap WaterParticipants initially assigned to Solution A Dose 2 will complete the three day course (days 1-3) and switch to the Solution B Dose 1 arm to complete the three day course (days 8-10). The dose level for Solution A Dose 2 is 25 grams of medical grade oral AC mixed with 4 ounces of tap water. Participants will report on a daily basis and consume the assigned combination of oral AC.
Solution B Dose 1, Then Solution A Dose 2	Experimental	Biological: Activated Charcoal and Apple JuiceParticipants initially assigned to Solution B Dose 1 will complete the three day course (days 1-3) and switch to the Solution A Dose 2 arm to complete the three day course (days 8-10). The dose level for Solution B Dose 1 is 12 grams of medical grade oral AC mixed with 4 ounces of apple juice. Participants will report on a daily basis and consume the assigned combination of oral AC.
Solution B Dose 2, Then Solution A Dose 1	Experimental	Biological: Activated Charcoal and Apple JuiceParticipants initially assigned to Solution B Dose 2 will complete the three day course (days 1-3) and switch to the Solution A Dose 1 arm to complete the three day course (days 8-10). The dose level for Solution B Dose 2 is 25 grams of medical grade oral AC mixed with 4 ounces of apple juice. Participants will report on a daily basis and consume the assigned combination of oral AC.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Activated charcoal and Tap WaterAlso: Medical grade AC, "Activated Charcoal Powder, USP", activated carbon.12 grams of AC mixed with Tap water or 25 grams of AC mixed with Tap water	Biological	Solution A Dose 1, Then Solution B Dose 2, Solution A Dose 2, Then Solution B Dose 1
Activated Charcoal and Apple Juice12 grams of AC with Apple Juice or 25 grams of AC with Apple Juice	Biological	Solution B Dose 1, Then Solution A Dose 2, Solution B Dose 2, Then Solution A Dose 1

Primary outcome

Average Palatability Rating
Time frame: two weeks
Each healthy volunteer will rate their experience using a 5-point scale (1=terrible, 2=bad, 3=okay, 4=good, 5=great) every day.

1 secondary outcome

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

Results and safety

Results posted to the registry on 26 Oct 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Solution A Dose 1, Then Solution B Dose 2	3	3
Solution A Dose 2, Then Solution B Dose 1	3	3
Solution B Dose 1, Then Solution A Dose 2	3	3
Solution B Dose 2, Then Solution A Dose 1	3	3

Primary outcome: Average Palatability Rating

Time frame: two weeks. Mean (Standard Deviation). Unit: score on a scale out of 5

Measure	Solution A Dose 1 n = 6	Solution A Dose 2 n = 6	Solution B Dose 1 n = 6	Solution B Dose 2 n = 6
Value	3.5 (0.9)	4.0 (0.8)	4.9 (0.2)	4.4 (0.6)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Participants were contacted during the first two weeks for any AEs.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Solution A Dose 1	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Solution A Dose 2	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Solution B Dose 1	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Solution B Dose 2	0 of 6 (0%)	3 of 6 (50%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Armin Rashidi, MD, PhD principal investigator

Masonic Cancer Center, University of Minnesota

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average Palatability Rating (time frame: two weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04204772.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.