Major Depressive Disorder, Healthy Volunteer Clinical Trial
Official title:
A Single-Center, Randomized, Investigator/Participant-Blind, Placebo-Controlled, Multiple-Ascending Dose, Semi-Sequential Adaptive Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Basimglurant Following Oral Administration in Healthy Subjects and in Patients With Major Depressive Disorder
| Verified date | November 2016 |
| Source | Hoffmann-La Roche |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 56 |
| Est. completion date | September 2015 |
| Est. primary completion date | September 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - 18 to 65 years of age, inclusive - Body weight at least 50 kg - Healthy male or female subjects (Healthy Cohorts) - Body mass index (BMI) 18 to 30 kg/m^2, inclusive (Healthy Cohorts) - Nonsmoker for at least 90 days prior to dosing (Healthy Cohorts) - Primary diagnosis of MDD without psychotic features (MDD Cohort) - BMI 18 to 35 kg/m^2, inclusive (MDD Cohort) - Current partial response to ongoing SSRI or SNRI antidepressant treatment at an adequate dose and for at least 4 weeks (MDD Cohort) - Clinical Global Impression of Severity (CGI-S) score 3 or greater (MDD Cohort) - Other regimens stable for at least 8 weeks prior to screening (MDD Cohort) Exclusion Criteria: - Pregnant or lactating women - History of alcohol or substance abuse in the past 6 months - Hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) - Clinically relevant electrocardiogram (ECG) abnormalities or a personal or family history of congenital long QT syndrome - Participation in an investigational study within 90 days of screening - Blood donation over 500 mL within 3 months of screening - Hypersensitivity to any study medication or excipients - Psychotic symptoms or comorbid mood disorder - Significant suicide risk - Major illness within 1 month before screening, or febrile illness within 1 week (Healthy Cohorts) - Average alcohol consumption of more than 2 units per day (Healthy Cohorts) - Multi-drug therapy for depression including antidepressants or adjunctive medications (MDD Cohort) - Prior use of basimglurant (MDD Cohort) - Cigarette use of greater than 1 pack per day (MDD Cohort) |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety: Incidence of adverse events (AEs) | Up to 10 weeks | No | |
| Primary | Safety: Suicidality as assessed using the Columbia Suicide Severity Rating Scale (C-SSRS) | Up to 10 weeks | No | |
| Primary | Safety: Sleep habits as assessed using a participant-recorded sleep diary | Up to 21 days | No | |
| Secondary | Pharmacokinetics: Maximum plasma concentration (Cmax) | Post dose on Day 1 and Day 22 (or final dose) | No | |
| Secondary | Pharmacokinetics: Area under the plasma concentration-time curve from 0 to 24 hours (AUC0-24) | Post dose on Day 1 | No | |
| Secondary | Pharmacokinetics: Area under the plasma concentration-time curve over the dosing interval (AUC0-tau) | Post dose on Day 22 (or final dose) | No | |
| Secondary | Pharmacokinetics: Time to maximum plasma concentration (Tmax) | Post dose on Day 1 and Day 22 (or final dose) | No | |
| Secondary | Pharmacokinetics: Trough plasma concentration (Ctrough) | Post dose on Day 1 and Day 22 (or final dose) | No | |
| Secondary | Pharmacokinetics: Apparent terminal elimination half-life (t1/2) | Post dose on Day 22 (or final dose) | No | |
| Secondary | Safety: QT interval corrected using the Fridericia method (QTcF) | Up to 10 weeks | No |