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Trial of Indole-3-Carbinol and Silibinin

NCT03687073 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2021-08-11

No results posted yet for this study

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.

Conditions

  • Smoking

Interventions

DRUG

Indole-3-Carbinol

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

DRUG

Silibinin

Cohorts 1 \& 4: 720mg

DRUG

Silibin

Cohort 3: 360mg

Sponsors & Collaborators

  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Principal Investigators

  • Naomi Fujioka, MD · Division of Hematology, Oncology and Transplantation, University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-29
Primary Completion
2021-05-07
Completion
2021-05-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03687073 on ClinicalTrials.gov