CYP2B6 Genetics and Drug Interactions in Healthy Volunteers

PHASE4CompletedINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

July 31, 2013

Primary Completion Date

May 31, 2016

Study Completion Date

May 31, 2016

Conditions
Healthy
Interventions
DRUG

Efavirenz

"The study has 4 phases:~Phase 1 (control)-Subjects will receive simultaneously a single dose of bupropion 100 mg, montelukast 10 mg and rosuvastatin 5 mg (cocktail) by mouth (control).~Phase 2 (inhibition)- a single 600 mg oral dose of efavirenz (blood draw at 30 min and 1 hour) will be administered with the cocktail drugs.~Phase 3 (home treatment with efavirenz): Subjects will take efavirenz at home (600 mg/day for 17 days).~Phase 4 (Induction) - is the same as phase 2. Blood samples (0 to 120 hrs) and urine voided over 48 hrs (Phases 1, 2 and 4) are collected. Blood draws will be made in phase 3 for trough concentration measurements."

DRUG

Bupropion

"The study has 4 phases:~Phase 1 (control)-Subjects will receive simultaneously a single dose of bupropion 100 mg, montelukast 10 mg and rosuvastatin 5 mg (cocktail) by mouth (control).~Phase 2 (inhibition)- a single 600 mg oral dose of efavirenz (blood draw at 30 min and 1 hour) will be administered with the cocktail drugs.~Phase 3 (home treatment with efavirenz): Subjects will take efavirenz at home (600 mg/day for 17 days).~Phase 4 (Induction) - is the same as phase 2. Blood samples (0 to 120 hrs) and urine voided over 48 hrs (Phases 1, 2 and 4) are collected. Blood draws will be made in phase 3 for trough concentration measurements."

DRUG

Rosuvastatin

"The study has 4 phases:~Phase 1 (control)-Subjects will receive simultaneously a single dose of bupropion 100 mg, montelukast 10 mg and rosuvastatin 5 mg (cocktail) by mouth (control).~Phase 2 (inhibition)- a single 600 mg oral dose of efavirenz (blood draw at 30 min and 1 hour) will be administered with the cocktail drugs.~Phase 3 (home treatment with efavirenz): Subjects will take efavirenz at home (600 mg/day for 17 days).~Phase 4 (Induction) - is the same as phase 2. Blood samples (0 to 120 hrs) and urine voided over 48 hrs (Phases 1, 2 and 4) are collected. Blood draws will be made in phase 3 for trough concentration measurements."

DRUG

Montelukast

"The study has 4 phases:~Phase 1 (control)-Subjects will receive simultaneously a single dose of bupropion 100 mg, montelukast 10 mg and rosuvastatin 5 mg (cocktail) by mouth (control).~Phase 2 (inhibition)- a single 600 mg oral dose of efavirenz (blood draw at 30 min and 1 hour) will be administered with the cocktail drugs.~Phase 3 (home treatment with efavirenz): Subjects will take efavirenz at home (600 mg/day for 17 days).~Phase 4 (Induction) - is the same as phase 2. Blood samples (0 to 120 hrs) and urine voided over 48 hrs (Phases 1, 2 and 4) are collected. Blood draws will be made in phase 3 for trough concentration measurements."

Trial Locations (1)

46202

Indiana University School of Medicine, Indianapolis

All Listed Sponsors
collaborator

National Institute of General Medical Sciences (NIGMS)

NIH

lead

Indiana University

OTHER

NCT02401256 - CYP2B6 Genetics and Drug Interactions in Healthy Volunteers | Biotech Hunter | Biotech Hunter