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Completed

NCT Number: 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)

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.

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Key information

Conditions

Major Depressive Disorder, Healthy Volunteer Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Garden Grove, California, 92845, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Basimglurant

Drug

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.

Placebo

Drug

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

Primary outcomes

  1. Safety: Incidence of adverse events (AEs)

    Time frame: Up to 10 weeks

  2. Safety: Suicidality as assessed using the Columbia Suicide Severity Rating Scale (C-SSRS)

    Time frame: Up to 10 weeks

  3. Safety: Sleep habits as assessed using a participant-recorded sleep diary

    Time frame: Up to 21 days

Secondary outcomes

  1. Pharmacokinetics: Maximum plasma concentration (Cmax)

    Time frame: Post dose on Day 1 and Day 22 (or final dose)

  2. Pharmacokinetics: Area under the plasma concentration-time curve from 0 to 24 hours (AUC0-24)

    Time frame: Post dose on Day 1

  3. Pharmacokinetics: Area under the plasma concentration-time curve over the dosing interval (AUC0-tau)

    Time frame: Post dose on Day 22 (or final dose)

  4. Pharmacokinetics: Time to maximum plasma concentration (Tmax)

    Time frame: Post dose on Day 1 and Day 22 (or final dose)

  5. Pharmacokinetics: Trough plasma concentration (Ctrough)

    Time frame: Post dose on Day 1 and Day 22 (or final dose)

  6. Pharmacokinetics: Apparent terminal elimination half-life (t1/2)

    Time frame: Post dose on Day 22 (or final dose)

  7. Safety: QT interval corrected using the Fridericia method (QTcF)

    Time frame: Up to 10 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
May 4, 2015
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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