Effect of Sodium Lauryl Sulfate on Drug Absorption

The Effect of Sodium Lauryl Sulfate on the Oral Absorption of Fexofenadine in Humans

This study is testing if adding sodium lauryl sulfate to an antihistamine can change how well the body absorbs the medication in people taking it.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years to 64 Years
• Sex: All
• Sponsor: University of California, San Francisco (Academic / other)
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT04534153 on ClinicalTrials.gov

What this trial studies

This study investigates how sodium lauryl sulfate (SLS), a common excipient in drug formulations, influences the absorption of fexofenadine, an antihistamine. It is a single-center, randomized, double-blind, 3-period crossover trial where participants will receive either fexofenadine alone or in combination with low and high doses of SLS. The study aims to measure the concentrations of SLS and fexofenadine in plasma and stool samples to assess pharmacokinetic parameters such as AUC and Cmax. The findings could provide insights into the role of excipients in drug efficacy.

Who should consider this trial

Good fit: Ideal candidates are healthy males and females aged 18-64 who can comply with study requirements.

Not a fit: Patients with allergies to fexofenadine or SLS, or those with chronic health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of how excipients affect drug absorption, potentially leading to improved drug formulations.

How similar studies have performed: While the impact of excipients on drug absorption has been studied, this specific approach focusing on SLS and fexofenadine is relatively novel.

Eligibility criteria

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 with chronic constipation.
6. Subjects consuming types of food and supplements with the potential to interfere with the study objectives as judged by the Investigator.
7. Subjects taking any drugs, especially known OATP2B1 substrates (aliskiren, atenolol, celiprolol, fexofenadine, rosuvastatin and ticlopidine, etc.) except birth control hormonal medications.
8. Subjects with a condition, disease, or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data.
9. Subjects with any disease affecting or impairing the function of the liver, kidney, or heart.
10. Subjects with gastrointestinal disease, gastrointestinal disorder, or gastrointestinal surgery.
11. 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.
12. Subjects who are smokers or have smoked in the past year and/or have smoked or ingested THC/marijuana in the past week, or who are unwilling to comply throughout the study period.
13. 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.
14. Subjects who are currently receiving any investigational agent or who have received any investigational agents within a period of 5 half-lives of the agent prior to the initiation of the current study.
15. Subjects who have donated whole blood within 8 weeks prior to study initiation or plan to donate blood during the study period.
16. Non-English speaking.
17. Subjects with abnormal laboratory results at Screening Visit as judged by the Investigator or study physician.

Where this trial is running

San Francisco, California

• Ucsf Ctsi Crc — San Francisco, California, United States (Recruiting)

Study contacts

• Principal investigator: Katherine Yang, PharmD, MPH — University of California, San Francisco
• Study coordinator: Katherine Yang, PharmD, MPH

Conditions The Impact of Excipients on Drug Absorption