Trial Outcomes & Findings for Determine the Effects of Gene Differences and Voriconazole on Enzyme CYP2B6 Activity in the Liver in Healthy Volunteers (NCT NCT01104376)

Last Updated: 2014-12-17

Results Overview

Effect of steady-state voriconazole on efavirenz Clearance in healthy volunteers (n=61) administered a single 100 mg oral dose of efavirenz at baseline (control phase) and after treatment with voriconazole to steady-state.

Recruitment status

COMPLETED

Study phase

Target enrollment

61 participants

Primary outcome timeframe

Baseline, 30 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24h after efavirenz

Results posted on

2014-12-17

Participant Flow

The study is started with Consent and screening (Laboratory and medical).Therefore 89 subjects gave consents and where screened. Of those 61 fully completed all phase of the study while 15 partially completed. The 13 subjects gave their consent and were screened, but they did not take any intervention because of abnormal labs.

Participant milestones

Participant milestones
Measure	CYP2B6 Activity CYP2B6 activity was measured using efavirenz metabolism and pharmacokinetics at baseline and after pretreatment with voriconazole. In phase 1 day 1 (control phase) a single 100mg dose of efavirenz will be administered. In phase 2 (voriconazole pretreatment phase), the subject will be pretreated with voriconazole (400mg twice daily on phase 2 day 8 and then 200mg twice daily for the next consecutive 8 days. In phase 3 (efavirenz plus voriconazole phase), the subject will receive on phase 3 day 10 100mg single dose of efavirenz along with 200mg of voriconazole twice daily.
Overall Study STARTED	89
Overall Study COMPLETED	61
Overall Study NOT COMPLETED	28

Reasons for withdrawal

Reasons for withdrawal
Measure	CYP2B6 Activity CYP2B6 activity was measured using efavirenz metabolism and pharmacokinetics at baseline and after pretreatment with voriconazole. In phase 1 day 1 (control phase) a single 100mg dose of efavirenz will be administered. In phase 2 (voriconazole pretreatment phase), the subject will be pretreated with voriconazole (400mg twice daily on phase 2 day 8 and then 200mg twice daily for the next consecutive 8 days. In phase 3 (efavirenz plus voriconazole phase), the subject will receive on phase 3 day 10 100mg single dose of efavirenz along with 200mg of voriconazole twice daily.
Overall Study Withdrawal by Subject	15
Overall Study Consented but excluded after labs	13

Baseline Characteristics

Determine the Effects of Gene Differences and Voriconazole on Enzyme CYP2B6 Activity in the Liver in Healthy Volunteers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CYP2B6 n=61 Participants Healthy volunteers will receive Efavirenz and Vericonazole as follow: In phase 1 day 1 (control phase) a single 100mg dose of efavirenz will be administered. In phase 2 (voriconazole pretreatment phase), the subject will be pretreated with voriconazole (400mg twice daily on phase 2 day 8 and then 200mg twice daily for the next consecutive 8 days. In phase 3 (efavirenz plus voriconazole phase), the subject will receive on phase 3 day 10 100mg single dose of efavirenz along with 200mg of voriconazole twice daily.
Age, Continuous	31.9 years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	25 Participants n=5 Participants
Race (NIH/OMB) White	33 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	61 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 30 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24h after efavirenz

Outcome measures

Outcome measures
Measure	CYP2B6 n=61 Participants Healthy volunteers will receive Efavirenz and Vericonazole as follow: In phase 1 day 1 (control phase) a single 100mg dose of efavirenz will be administered. In phase 2 (voriconazole pretreatment phase), the subject will be pretreated with voriconazole (400mg twice daily on phase 2 day 8 and then 200mg twice daily for the next consecutive 8 days. In phase 3 (efavirenz plus voriconazole phase), the subject will receive on phase 3 day 10 100mg single dose of efavirenz along with 200mg of voriconazole twice daily.
Measure Efavirenz Clearance Control	45.51 ml/min/kg Standard Deviation 18.3
Measure Efavirenz Clearance Vericonazole	20.03 ml/min/kg Standard Deviation 8.5

Adverse Events

CYP2B6

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Zeruesenay Desta, PhD

Indiana University

Phone: 317-630-8860

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place