COMPLETED

Excipient Effect on Drug Absorption in Humans

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The Impact of Excipients on Drug Absorption

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-01-31

Study Completion:2025-08-18

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04534153

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 64 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Principal Investigator

Katherine Yang, PharmD, MPH

PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Study Locations (Sites)

Ucsf Ctsi Crc

San Francisco, California, 94143

United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

Katherine Yang, PharmD, MPH, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-31

Study Completion Date2025-08-18

Study Record Updates

Study Start Date2023-01-31

Study Completion Date2025-08-18

Terms related to this study

Additional Relevant MeSH Terms

The Impact of Excipients on Drug Absorption