Pharmacokinetic Interaction Study of Efavirenz and American Ginseng in Healthy Volunteers

• Status: Completed
• Trial end date: 2011-03-14
• Target enrollment: 0
• Participant gender: Male

Summary

This is a 4-week sequential drug interaction study to measure the effects of American ginseng on efavirenz pharmacokinetics using steady-state 24-hour Area Under the Curve (AUC) and Cmax as the primary comparison measures in healthy male volunteers. Efavirenz Cmin, T1/2, tmax, and clearance will also be assessed as secondary outcome measures. This study is a phase I, prospective, within-subject, fixed-order, two-period, multiple dose, open label, drug interaction study, to determine the stead-state plasma pharmacokinetic profile of efavirenz before and after concurrent treatment with American ginseng. The investigators hypothesis is that concurrent oral administration of American ginseng for up to 14 days will not significantly alter the steady-state plasma pharmacokinetic of efavirenz.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)
• Treatments: Efavirenz

Criteria

Inclusion Criteria:

1. All enrollees will be healthy volunteers, ≥18 years of age with

2. Negative HIV-1 serology, documented by any licensed ELISA test kit

3. Ability and willingness to provide a signed informed consent and comply with study requirements

4. Males only because efavirenz has been reported to have teratogenic properties

5. Estimated creatinine clearance ≥50 mL/minute, as calculated by the Cockcroft-Gault method

6. Normal laboratory and physical examination, as judged by the Principal Investigator

7. Good peripheral venous access

8. Willingness and ability to take oral medications.

Exclusion Criteria:

1. Known or suspected hypersensitivity to American Ginseng (AG) or efavirenz

2. Taking any prescription, over-the-counter medication, or Complementary and alternative medicine (CAM) agents within 30 days of study enrolment

3. Evidence of active drug or alcohol abuse

4. Any other medical or psychological condition that might, in the opinion of the investigator, interfere with participation in the study or put subjects at undue risk

5. Hospitalization or therapy for serious illness within 30 days prior to study entry, as judged by the investigator

6. Participation in any investigational drug trials within 30 days prior to study entry that, in the opinion of the investigator, would preclude study participation.