AzTrials
AzTrials

SmokingPhase 1NCT03687073

Trial of Indole-3-Carbinol and Silibinin

A Phase 1 study testing Indole-3-Carbinol, Silibinin and Silibin in people with Smoking, 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
Search all trials

Trial summary

This is a non-therapeutic, Phase 1 clinical trial to examine the safety, pharmacokinetic (PK) characteristics, and pharmacodynamics (PD) effect of indole-3-carbinol (I3C) and silibinin (Sil) in healthy subjects. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Smoking
What is being tested?
Indole-3-Carbinol, Silibinin and Silibin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
29 Nov 2018to 7 May 2021
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Adult ≥ 18 years old
  • Current smoker of ≥ 8 cigarettes per day for at least the last 6 months by self-report
  • Adequate blood counts, and adequate liver and kidney function defined as follows:
  • Hemoglobin ≥ 9 g/dL for women, ≥ 10 g/dL for men
  • Platelet count ≥ 100 x 10^9/L
  • Total bilirubin ≤ Institutional upper limit of normal (≤ 1.3 mg/dL for UMMC)
Show all 9Show fewer
  • ALT ≤ 1.5 times institutional upper limit of normal
  • Creatinine ≤ 1.4 g/dL and estimated GFR ≥ 80 mL/min/1.7m2
  • Able to understand the experimental nature of the study and provide informed written consent

Who cannot join

  • Chronic proton pump inhibitor, H2-blocker (i.e., ranitidine, famotidine), and/or calcium carbonate use
  • History of gastric bypass surgery, gastric banding, bowel resection, malabsorption syndromes such as celiac sprue or pancreatic insufficiency, or other conditions that may affect gastric or intestinal absorption of nutrients
  • Current use of tobacco products other than cigarettes (i.e. snuff, snuz, smokeless tobacco, cigars, pipes), or use of these products within 3 months of study registration
  • Major or chronic medical disease, including heart disease, poorly controlled diabetes, etc., to be adjudicated by the principal investigator
  • Known active malignancy
  • History of aerodigestive malignancies
Show all 11Show fewer
  • Women who are pregnant, intend to become pregnant within 3 months of study registration, or who are lactating. Women of childbearing potential must have a negative urine pregnancy test within 14 days of starting the assigned intervention
  • Antibiotic use within 2 months of study registration by self-report
  • History of respiratory tract cancer
  • Known allergy to I3C, Sil, or its components
  • Psychiatric and/or social situations that would potentially limit compliance with study requirements

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: Trial of Indole-3-Carbinol & Silibinin

This is a non-therapeutic, Phase 1 clinical trial to examine the safety, pharmacokinetic (PK) characteristics, and pharmacodynamics (PD) effect of indole-3-carbinol (I3C) and silibinin (Sil) in healthy subjects.

Conditions
Smoking
Being tested
Indole-3-Carbinol, Silibinin, Silibin
Medical subject headings
Smoking

What participants receive

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

  • Indole-3-CarbinolDrug

    Also called 13C

    Cohorts 2, 3, \& 4: 400 mg PO BID

  • SilibininDrug

    Also called Sil

    Cohorts 1 \& 4: 720mg

  • SilibinDrug

    Also called Sil

    Cohort 3: 360mg

Study groups in NCT03687073
Study groupRoleWhat they receive
Single-dose PK studyExperimentalSubjects will take the assigned dose of I3C, Sil, or I3C + Sil once at the study center. Ten mL of blood will be collected at the time points described in Section 9.14. Concurrently, urine will also be collected for 24 hours after the first dose of I3C, Sil or I3C + Sil, divided into the time intervals.
Receives: Drug: Indole-3-Carbinol; Drug: Silibinin; Drug: Silibin
Multi-dose PK StudyExperimentalSubjects will take the assigned dose of I3C, Sil, or I3C + Sil for 8 weeks. Ten mL of blood will be collected at the time points described in Section 9.14. Concurrently, urine will be collected for 24 hours after the first dose of I3C, Sil or I3C + Sil, divided into the time intervals.
Receives: Drug: Indole-3-Carbinol; Drug: Silibinin; Drug: Silibin
Safety StudyExperimentalSafety data will be generated during the multi-dose PK and PD study, as DLT is not anticipated in the single-dose PK study. Enrollment into dose cohorts 1 and 2 can occur on a continuous basis. Enrollment for dose cohorts 3 and 4 will be done sequentially using a modified 3+3 design (see Section 8.2). The first three subjects enrolled into a dose cohort must complete at least 21 days of the multi-dose PK/PD study without a DLT before the remaining 4 subjects in the cohort can be enrolled.
Receives: Drug: Indole-3-Carbinol; Drug: Silibinin; Drug: Silibin
Cohort 4 PD StudyExperimentalThe effect of I3C, Sil, or I3C + Sil on the pharmacodynamic endpoints listed under the Secondary Objectives in Section 1.2 will be characterized. This PD study will be done concurrently with the multi-dose PK study. Subjects will take the assigned dose of I3C, Sil, or I3C + Sil for 8 weeks. Nasal epithelium, oral cavity cells, buccal cells, blood, and urine will be collected at the time points described in the study calendar in Section 4.0.
Receives: Drug: Indole-3-Carbinol; Drug: Silibinin; Drug: Silibin

What is being measured

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

  1. Safety of the combination of I3C + Sil

    Incidence of Dose Limiting Toxicities (DLTs)

    Measured: Week 8

  2. Pharmacokinetic profile of I3C + Sil

    AUC

    Measured: Week 8

  3. Pharmacokinetic profile of I3C + Sil

    Cmax

    Measured: Week 8

  4. Pharmacokinetic profile of I3C + Sil

    Half-life

    Measured: Week 8

  5. Pharmacokinetic profile of I3C + Sil

    Elimination rate

    Measured: Week 8

  6. Pharmacokinetic profile of I3C + Sil

    Plasma clearance

    Measured: Week 8

  7. Pharmacokinetic profile of I3C + Sil

    Renal clearance

    Measured: Week 8

  8. Pharmacokinetic profile of I3C + Sil

    Accumulation

    Measured: Week 8

Secondary outcomes (13)

  1. Effect of I3C, Sil, or I3C + Sil on circulating inflammatory markers

    Change in inflammatory markers IL-1B, TNF-a, IL-6, IL-8, Cox-2, prostaglandin E, and C-reactive protein

    Measured: Week 8

  2. Effect of I3C, Sil, or I3C + Sil on circulating immunophenotype

    Change in circulating immunophenotype

    Measured: Week 8

  3. Effect of I3C, Sil, or I3C + Sil on protein expression of phosphorylated-Akt (pAkt), pERK, pSTAT3 and NF-kB from peripheral blood mononuclear cells (PBMC)

    Change in protein expression of phosphorylated-Akt (pAkt), pERK, pSTAT3 and NF-kB from peripheral blood mononuclear cells (PBMC)

    Measured: Week 8

  4. Effect of I3C, Sil, or I3C + Sil on RNA sequencing from PBMC

    Change in of I3C, Sil, or I3C + Sil on

    Measured: Week 8

  5. Effect of I3C, Sil, or I3C + Sil on PIK3CA pathway signaling in buccal cells

    Change in PIK3CA pathway signaling in buccal cells

    Measured: Week 8

  6. Effect of I3C, Sil, or I3C + Sil on PIK3CA pathway signaling in oral cavity cells

    Change in PIK3CA pathway signaling in oral cavity cells

    Measured: Week 8

  7. Effect of I3C, Sil, or I3C + Sil on PIK3CA pathway signaling in nasal mucosa

    Change in PIK3CA pathway signaling in nasal mucosa

    Measured: Week 8

  8. Effect of I3C, Sil, or I3C + Sil on fasting glucose

    Change in fasting glucose

    Measured: Week 8

  9. Effect of I3C, Sil, or I3C + Sil on fasting insulin

    Change in fasting insulin

    Measured: Week 8

  10. Effect of I3C, Sil, or I3C + Sil on lipid profile

    Change in lipid profile

    Measured: Week 8

  11. Effect of I3C, Sil, or I3C + Sil on leptin

    Change in leptin

    Measured: Week 8

  12. Effect of I3C, Sil, or I3C + Sil on body weight

    Change in body weight

    Measured: Week 8

  13. Effect of I3C, Sil, or I3C + Sil on waist circumference

    Change in waist circumference

    Measured: Week 8

Timeline

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

  1. First posted27 Sep 2018
  2. Study start29 Nov 2018
  3. Primary completion7 May 2021
  4. Study completion7 May 2021

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03687073
Sponsor's protocol ID
2017LS075
Status last verified
Aug 2021
First submitted
14 Sep 2018
Last updated
11 Aug 2021
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Indole-3-Carbinol, Silibinin and Silibin in people with Smoking, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.

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 9 inclusion and 11 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 11 Aug 2021. 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?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Safety of the combination of I3C + Sil (time frame: Week 8). The study lists 8 primary outcomes in all. 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 NCT03687073.

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 11 Aug 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in