Pharmacokinetic Interaction Study of Efavirenz and American Ginseng in Healthy Volunteers

NCT01136928 | Completed Phase 1 DMC

• 2 other identifiers: NA_00038067R01AT005526-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

Antiretroviral therapy; American ginseng; Efavirenz; Cytochrome P450 enzymes; Complementary and Alternative Medicine; Herbal; Pharmacikinetics; Healthy volunteers

Outcome Measures

Primary Outcomes (1)

• To compare efavirenz AUC0-24 and Cmax when dosed alone to steady-state efavirenz AUC0-24 and Cmax given concurrently with American ginseng. Efavirenz AUC0-24 with and without American ginseng

  Compare efavirenz AUC0-24 and Cmax when dosed alone at 600 mg daily, to steady-state efavirenz AUC0-24 and Cmax dosed at 600 mg daily and given concurrently with American ginseng 3000 mg daily.

  14 days of efavirenz alone, followed by 14 days of concurrent administration of efavirenz and American ginseng

Secondary Outcomes (4)

• Efavirenz tmax with and without American ginseng

  14 days of efavirenz alone, followed by 14 days of concurrent administration of efavirenz and American ginseng

• Efavirenz Cmin with and without American ginseng

  14 days of efavirenz alone, followed by 14 days of concurrent administration of efavirenz and American ginseng

• Efavirenz Clearance with and without American ginseng

  14 days of efavirenz alone, followed by 14 days of concurrent administration of efavirenz and American ginseng

• Efavirenz T1/2 with and without American ginseng

  14 days of efavirenz alone, followed by 14 days of concurrent administration of efavirenz and American ginseng

Study Arms (1)

American ginseng and efavirenz

EXPERIMENTAL

This is a sequential study. Healthy volunteers will receive efavirenz alone for 14 days followed by efavirenz plus American ginseng for an additional 14 days.

Drug: American ginseng

Interventions

American ginseng DRUG

Healthy volunteers will ge given efavirnez 600 mg daily monotherapy for 14 days followed by efavirenz 600 mg PLUS American ginseng 3000 mg daily for an additional 14 days.

Also known as: Efavienz (Sustiva)

American ginseng and efavirenz

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All enrollees will be healthy volunteers, ≥18 years of age with
• Negative HIV-1 serology, documented by any licensed ELISA test kit
• Ability and willingness to provide a signed informed consent and comply with study requirements
• Males only because efavirenz has been reported to have teratogenic properties
• Estimated creatinine clearance ≥50 mL/minute, as calculated by the Cockcroft-Gault method
• Normal laboratory and physical examination, as judged by the Principal Investigator
• Good peripheral venous access
• Willingness and ability to take oral medications.

You may not qualify if:

• Known or suspected hypersensitivity to American Ginseng (AG) or efavirenz
• Taking any prescription, over-the-counter medication, or Complementary and alternative medicine (CAM) agents within 30 days of study enrolment
• Evidence of active drug or alcohol abuse
• 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
• Hospitalization or therapy for serious illness within 30 days prior to study entry, as judged by the investigator
• Participation in any investigational drug trials within 30 days prior to study entry that, in the opinion of the investigator, would preclude study participation.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287-5554, United States

Location

MeSH Terms

Interventions

Asian ginseng; efavirenz

Study Officials

• Adriana Andrade, MD, MPH

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2010
• First Posted: June 4, 2010
• Study Start: September 28, 2010
• Primary Completion: March 14, 2011
• Study Completion: March 14, 2011
• Last Updated: June 15, 2018

Record last verified: 2018-06

Locations

US (1)