The study will assess the safety, tolerability, and pharmacokinetics of basimglurant compared to placebo after multiple ascending oral doses for up to 22 days in healthy subjects and in patients with MDD on stable selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI) background therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
56
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.
Participants will receive 22 days of once-daily oral matching placebo capsules.
Unnamed facility
Garden Grove, California, United States
Safety: Incidence of adverse events (AEs)
Time frame: Up to 10 weeks
Safety: Suicidality as assessed using the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to 10 weeks
Safety: Sleep habits as assessed using a participant-recorded sleep diary
Time frame: Up to 21 days
Pharmacokinetics: Maximum plasma concentration (Cmax)
Time frame: Post dose on Day 1 and Day 22 (or final dose)
Pharmacokinetics: Area under the plasma concentration-time curve from 0 to 24 hours (AUC0-24)
Time frame: Post dose on Day 1
Pharmacokinetics: Area under the plasma concentration-time curve over the dosing interval (AUC0-tau)
Time frame: Post dose on Day 22 (or final dose)
Pharmacokinetics: Time to maximum plasma concentration (Tmax)
Time frame: Post dose on Day 1 and Day 22 (or final dose)
Pharmacokinetics: Trough plasma concentration (Ctrough)
Time frame: Post dose on Day 1 and Day 22 (or final dose)
Pharmacokinetics: Apparent terminal elimination half-life (t1/2)
Time frame: Post dose on Day 22 (or final dose)
Safety: QT interval corrected using the Fridericia method (QTcF)
Time frame: Up to 10 weeks
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