A Study to Investigate the Effect of Itraconazole on the PK of Multiple Doses of Balovaptan in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

July 10, 2018

Primary Completion Date

November 9, 2018

Study Completion Date

November 9, 2018

Conditions
Healthy Volunteers
Interventions
DRUG

Balovaptan

"In Period 1, balovaptan was administered orally once daily (qd) on Days 1 to 10.~In Period 2, balovaptan was administered qd on Days 6 to 20."

DRUG

Itraconazole

In Period 2, 200 mg itraconzole was administered bid for 4 days and qd on Days 5-20, approximately 12 hours apart. On Days 6-20, 200 mg itraconazole was administered qd.

Trial Locations (1)

9728 NZ

Pra International Group B.V, Groningen

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT03579719 - A Study to Investigate the Effect of Itraconazole on the PK of Multiple Doses of Balovaptan in Healthy Volunteers | Biotech Hunter | Biotech Hunter