Excipient Effect on Drug Absorption in Humans

NCT ID: NCT04534153

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-31
• Study Completion Date: 2025-08-18

Brief Summary

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.

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.

Conditions

The Impact of Excipients on Drug Absorption

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Fexofenadine without SLS

Participants will be administered by mouth with a capsule containing 120 mg fexofenadine hydrochloride and 101 mg microcrystalline cellulose

Group Type: EXPERIMENTAL

Fexofenadine Hydrochloride without sodium lauryl sulfate

Intervention Type: DRUG

without sodium lauryl sulfate

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

Group Type: EXPERIMENTAL

Fexofenadine Hydrochloride with sodium lauryl sulfate

Intervention Type: DRUG

with sodium lauryl sulfate

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

Group Type: EXPERIMENTAL

Fexofenadine Hydrochloride with sodium lauryl sulfate

Intervention Type: DRUG

with sodium lauryl sulfate

Interventions

Fexofenadine Hydrochloride without sodium lauryl sulfate

without sodium lauryl sulfate

Intervention Type: DRUG

Fexofenadine Hydrochloride with sodium lauryl sulfate

with sodium lauryl sulfate

Intervention Type: DRUG

Other Intervention Names

Allegra; Allegra

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Food and Drug Administration (FDA)

FED

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katherine Yang, PharmD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Ucsf Ctsi Crc

San Francisco, California, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

20-31871

Identifier Type: -

Identifier Source: org_study_id