NCT02433093View on ClinicalTrials.gov

A Study of the Safety, Tolerability, and Pharmacokinetics of Multiple-Ascending Dose Basimglurant in Healthy Subjects and in Patients With Major Depressive Disorder (MDD)

PHASE1CompletedINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

April 30, 2015

Primary Completion Date

September 30, 2015

Study Completion Date

September 30, 2015

Conditions
Major Depressive Disorder, Healthy Volunteer
Interventions
DRUG

Basimglurant

Participants will receive once-daily oral basimglurant capsules in a multiple ascending dose regimen. Basimglurant dose will be titrated over 22 days; dose escalations will be separated by at least 4 days, with the final dose administered for a minimum of 14 days. The minimum starting dose will be 1.5 mg, which can be titrated up to a maximum dose of 4.0 mg. Intrapatient dose increments will not exceed 1.0 mg every 4 days.

DRUG

Placebo

Participants will receive 22 days of once-daily oral matching placebo capsules.

Trial Locations (1)

92845

Garden Grove

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02433093 - A Study of the Safety, Tolerability, and Pharmacokinetics of Multiple-Ascending Dose Basimglurant in Healthy Subjects and in Patients With Major Depressive Disorder (MDD) | Biotech Hunter | Biotech Hunter