CYP3A4 Induction and Mineral Homeostasis

• Status: Completed
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether changes in the activity of the enzyme CYP3A4 can change the Vitamin D and bone mineral homeostasis.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Washington
• Treatments: Clarithromycin; Rifampin

Criteria

Inclusion Criteria:

• Subjects with no history of significant medical conditions including cardiac, pulmonary, gastrointestinal, or renal disease, HIV, diabetes mellitus or Hepatitis B or C

• Subjects will be males or females 18-60 years of age

• Subjects must read and understand English

• Subjects must be able to provide informed consent

• Subjects must be willing to avoid prescription medications, OTC drugs, dietary supplements and foods that are known to modulate CYP3A4 expression or activity

• Subjects must be willing to maintain a consistent consumption of calcium and Vitamin D during the study and maintain a daily logbook of their dietary consumption

• Women not currently pregnant or lactating. In addition, women participants of childbearing age must be willing to utilize a barrier method of birth control (sterilization will be acceptable)

• Subjects will have no known allergies to the study drugs to be used

• Subject's corrected QTc interval obtained by electrocardiogram will be ≤ 430 ms in men or ≤ 450 ms in women

Exclusion Criteria:

• Subjects with any significant chronic medical condition, including cardiac, pulmonary, gastrointestinal, or renal disease, HIV, diabetes mellitus or Hepatitis B or C

• Subjects less than 18 or greater than 60 years of age

• Subjects unable to read and understand English

• Subjects unable to provide informed consent

• Subjects unable to avoid prescription medications, OTC drugs, dietary supplements and foods that are known to modulate CYP3A4 expression or activity

• Subjects not willing to maintain a consistent consumption of calcium and Vitamin D during the study and maintain a daily logbook of their dietary consumption

• Women who are pregnant or lactating and women participants of childbearing age not willing to utilize a barrier method of birth control (sterilization will be acceptable)

• Subjects with allergies to rifampin, clarithromycin or grapefruit juice

• Potential participants will be excluded if they are concurrently participating in another research study

• Subjects with corrected QTc interval > 430 ms in men or > 450 ms in women on electrocardiogram