Excipient Effect on Drug Absorption in Humans

Overview

The purpose of this study is to determine if sodium lauryl sulfate (SLS), a non-drug ingredient commonly added in drug products, affect absorption of drugs that are given together with the ingredient. Investigators want to find out if drug absorption is different in people taking the drug alone compared to people taking the drug with low and high amounts of sodium lauryl sulfate at the same time.

Full Title of Study: “The Effect of Sodium Lauryl Sulfate on the Oral Absorption of Fexofenadine in Humans”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: December 2022

Detailed Description

This is a single-center, randomized, double-blind, 3-period crossover trial. Participants will be randomized to receive a Control capsule (fexofenadine single agent) under Treatment Arm 1 or a Test 1 capsule (fexofenadine and 3 mg SLS) under Treatment Arm 2 or Test 2 capsule (fexofenadine and 30 mg SLS) under Treatment Arm 3. Investigators will assess the effect of SLS on the absorption of fexofenadine by measuring SLS and fexofenadine concentrations in plasma and stool samples and determine the change in AUC (area under the curve), Cmax and other pharmacokinetic parameters, between Treatment Arms 2 or 3 and Treatment Arm 1.

Interventions

  • Drug: Fexofenadine Hydrochloride without sodium lauryl sulfate
    • without sodium lauryl sulfate
  • Drug: Fexofenadine Hydrochloride with sodium lauryl sulfate
    • with sodium lauryl sulfate

Arms, Groups and Cohorts

  • Experimental: Fexofenadine without SLS
    • Participants will be administered by mouth with a capsule containing 120 mg fexofenadine hydrochloride and 101 mg microcrystalline cellulose
  • Experimental: Fexofenadine and 3 mg SLS
    • Participants will be administered by mouth with a capsule containing 120 mg fexofenadine hydrochloride, 3 mg SLS and 101 mg microcrystalline cellulose
  • Experimental: Fexofenadine and 30 mg SLS
    • Participants will be administered by mouth with a capsule containing 120 mg fexofenadine hydrochloride, 30 mg SLS and 101 mg microcrystalline cellulose

Clinical Trial Outcome Measures

Primary Measures

  • Area under the plasma concentration versus time curve (AUC) of Fexofenadine
    • Time Frame: 0-48 hours
    • To determine whether SLS decreases the fexofenadine area under the curve (AUC) between Fexofenadine + 3 mg SLS or Fexofenadine + 30 mg SLS and Fexofenadine only.
  • Maximum Plasma Concentration (Cmax) of Fexofenadine
    • Time Frame: 0-48 hours
    • To determine whether SLS decreases the fexofenadine Cmax between Fexofenadine + 3 mg SLS or Fexofenadine + 30 mg SLS and Fexofenadine only.

Secondary Measures

  • Sodium lauryl sulfate plasma concentration
    • Time Frame: 0-48 hours
    • To determine plasma SLS concentration in order to understand the absorption of SLS in humans
  • Fexofenadine stool amount
    • Time Frame: 0-48 hours
    • To determine stool amount of fexofenadine and compare between the fexofenadine only arm to the 3 mg SLS and the 30 mg SLS arm.
  • Sodium lauryl sulfate stool amount
    • Time Frame: 0-48 hours
    • To determine stool amount of sodium lauryl sulfate and compare between the fexofenadine only arm to the 3 mg SLS and the 30 mg SLS arm.

Participating in This Clinical Trial

Inclusion Criteria

1. Healthy volunteers of all ethnic groups and races. 2. Male and females between the ages of 18-64 years old, inclusive. 3. Subjects who are willing to avoid ingestion of fruit juices and citrus bioflavonoids, such as grapefruit extract, hesperidin supplement and naringin supplement, for a period extending from one week prior to the initiation of the study until its completion. 4. Written informed consent obtained from the subject and ability for subject to comply with the requirements of the study. Exclusion Criteria:

1. Subjects with extreme obesity (BMI > 35). 2. Subjects who are allergic to fexofenadine or SLS. 3. Subjects who have hemoglobin level lower than 12 g/dL. 4. Subjects who are pregnant, breastfeeding, or unwilling to practice birth control during participation in the study. 5. Subjects consuming types of food and supplements with the potential to interfere with the study objectives as judged by the Investigator. 6. Subjects taking any drugs, especially known OATP2B1 substrates (aliskiren, atenolol, celiprolol, fexofenadine, rosuvastatin and ticlopidine, etc.) except birth control hormonal medications. 7. Subjects with a condition, disease, or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data. 8. Subjects with any disease affecting or impairing the function of the liver, kidney or heart. 9. Subjects with gastrointestinal disease, gastrointestinal disorder, or gastrointestinal surgery. 10. Subjects with known infection with HIV, Hepatitis B or Hepatitis C (as determined by questionnaire, no laboratory diagnostics concerning these diseases will be performed within the present study). Volunteers who are cured of past Hepatitis C infection are eligible to participate with a doctor's approval letter). 11. Subjects who are smokers or have smoked in the past year and/or have smoked or ingested tetrahydrocannabinol/marijuana in the past week, or who are unwilling to comply throughout the study period. 12. Alcohol use on average > 2 servings/day or > 14 servings/wk (Serving size: 12oz beer/4oz wine/2oz hard liquor) in the past week or self-reported binge drinking. 13. Participating in another research study while participating in this research study. 14. Non-English speaking. 15. Subjects with abnormal laboratory results at Screening Visit as judged by the Investigator or study physician.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 64 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of California, San Francisco
  • Collaborator
    • Food and Drug Administration (FDA)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Kathleen M Giacomini, Ph.D., Principal Investigator, University of California, San Francisco
  • Overall Contact(s)
    • Kathleen M Giacomini, Ph.D., 415-476-1936, kathy.giacomini@ucsf.edu

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.