A Study of the Safety, Tolerability, and Pharmacokinetics of Multiple-Ascending Dose Basimglurant in Healthy Subjects and in Patients With Major Depressive Disorder (MDD)
Status and phase
Completed
Phase 1
Conditions
Major Depressive Disorder, Healthy Volunteer
Treatments
Drug: Basimglurant
Drug: Placebo
Details and patient eligibility
About
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.
Enrollment
56 patients
Sex
All
Ages
18 to 65 years old
Volunteers
Accepts Healthy Volunteers
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)
Trial design
56 participants in 7 patient groups, including a placebo group
Basimglurant: Healthy Cohort (1)
Experimental group
Description:
Healthy participants assigned to basimglurant will receive a 22-day ascending dose regimen. Cohort 1 will receive a prespecified titration scheme; however, adaptive titration schemes may be applied in subsequent cohorts.
Treatment:
Drug: Basimglurant
Basimglurant: Healthy Cohort (2)
Experimental group
Description:
Healthy participants assigned to basimglurant will receive a 22-day ascending dose regimen. The dosing scheme for Cohort 2 will be selected in accordance with decision criteria on the basis of the incidence of severe AEs in Cohort 1.
Treatment:
Drug: Basimglurant
Basimglurant: Healthy Cohort (3)
Experimental group
Description:
Healthy participants assigned to basimglurant will receive a 22-day ascending dose regimen. The dosing scheme for Cohort 3 will be selected in accordance with decision criteria on the basis of the incidence of severe AEs in preceding Cohorts 1 and 2.
Treatment:
Drug: Basimglurant
Basimglurant: Healthy Cohort (4)
Experimental group
Description:
Healthy participants assigned to basimglurant will receive a 22-day ascending dose regimen. The dosing scheme for Cohort 4 will be selected in accordance with decision criteria on the basis of the incidence of severe AEs in preceding Cohorts 1, 2, and 3.
Treatment:
Drug: Basimglurant
Basimglurant: MDD Cohort (5)
Experimental group
Description:
Participants with MDD assigned to basimglurant will receive a 22-day ascending dose regimen. The dosing scheme for Cohort 5 may differ from those previously evaluated; however, the titration steps and the highest dose tested will remain equal to or lower than the doses tested in Cohorts 1 to 4.
Treatment:
Drug: Basimglurant
Placebo: Healthy Cohorts (1 to 4)
Placebo Comparator group
Description:
Healthy participants will receive a 22-day regimen of matching placebo capsules.
Treatment:
Drug: Placebo
Placebo: MDD Cohort (5)
Placebo Comparator group
Description:
Participants with MDD will receive a 22-day regimen of matching placebo capsules.
Treatment:
Drug: Placebo
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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