Major Depressive Disorder, Healthy VolunteerPhase 1NCT02433093
A Study of the Safety, Tolerability, and Pharmacokinetics of Multiple-Ascending Dose Basimglurant in Healthy Subjects and in Patients With Major Depressive Disorder (MDD)
A Phase 1 study testing Basimglurant in people with Major Depressive Disorder, Healthy Volunteer, run by Hoffmann-La Roche at 1 site in United States.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder, Healthy Volunteer
- What is being tested?
- Basimglurant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Sep 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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)
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- Basimglurant, Placebo
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BasimglurantDrug
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.
PlaceboDrug
Participants will receive 22 days of once-daily oral matching placebo capsules.
| Study group | Role | What they receive |
|---|---|---|
| Basimglurant: Healthy Cohort (1) | Experimental | 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. Receives: Drug: Basimglurant |
| Basimglurant: Healthy Cohort (2) | Experimental | 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. Receives: Drug: Basimglurant |
| Basimglurant: Healthy Cohort (3) | Experimental | 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. Receives: Drug: Basimglurant |
| Basimglurant: Healthy Cohort (4) | Experimental | 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. Receives: Drug: Basimglurant |
| Basimglurant: MDD Cohort (5) | Experimental | 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. Receives: Drug: Basimglurant |
| Placebo: Healthy Cohorts (1 to 4) | Placebo comparator | Healthy participants will receive a 22-day regimen of matching placebo capsules. Receives: Drug: Placebo |
| Placebo: MDD Cohort (5) | Placebo comparator | Participants with MDD will receive a 22-day regimen of matching placebo capsules. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Incidence of adverse events (AEs)
Measured: Up to 10 weeks
Safety: Suicidality as assessed using the Columbia Suicide Severity Rating Scale (C-SSRS)
Measured: Up to 10 weeks
Safety: Sleep habits as assessed using a participant-recorded sleep diary
Measured: Up to 21 days
Secondary outcomes (7)
Pharmacokinetics: Maximum plasma concentration (Cmax)
Measured: 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)
Measured: Post dose on Day 1
Pharmacokinetics: Area under the plasma concentration-time curve over the dosing interval (AUC0-tau)
Measured: Post dose on Day 22 (or final dose)
Pharmacokinetics: Time to maximum plasma concentration (Tmax)
Measured: Post dose on Day 1 and Day 22 (or final dose)
Pharmacokinetics: Trough plasma concentration (Ctrough)
Measured: Post dose on Day 1 and Day 22 (or final dose)
Pharmacokinetics: Apparent terminal elimination half-life (t1/2)
Measured: Post dose on Day 22 (or final dose)
Safety: QT interval corrected using the Fridericia method (QTcF)
Measured: Up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study startApr 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder, Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02433093
- Sponsor's protocol ID
- NP29583
- Status last verified
- Nov 2016
- First submitted
- 29 Apr 2015
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02433093
- Acronym / sponsor ID
- NP29583
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 4 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Basimglurant: Healthy Cohort (1) | Experimental | Drug: BasimglurantHealthy 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. |
| Basimglurant: Healthy Cohort (2) | Experimental | Drug: BasimglurantHealthy 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. |
| Basimglurant: Healthy Cohort (3) | Experimental | Drug: BasimglurantHealthy 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. |
| Basimglurant: Healthy Cohort (4) | Experimental | Drug: BasimglurantHealthy 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. |
| Basimglurant: MDD Cohort (5) | Experimental | Drug: BasimglurantParticipants 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. |
| Placebo: Healthy Cohorts (1 to 4) | Placebo comparator | Drug: PlaceboHealthy participants will receive a 22-day regimen of matching placebo capsules. |
| Placebo: MDD Cohort (5) | Placebo comparator | Drug: PlaceboParticipants with MDD will receive a 22-day regimen of matching placebo capsules. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BasimglurantParticipants 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 | Basimglurant: Healthy Cohort (1), Basimglurant: Healthy Cohort (2), Basimglurant: Healthy Cohort (3), Basimglurant: Healthy Cohort (4), Basimglurant: MDD Cohort (5) |
| PlaceboParticipants will receive 22 days of once-daily oral matching placebo capsules. | Drug | Placebo: Healthy Cohorts (1 to 4), Placebo: MDD Cohort (5) |
Primary outcome
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
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Basimglurant in people with Major Depressive Disorder, Healthy Volunteer, run by Hoffmann-La Roche at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Incidence of adverse events (AEs) (time frame: Up to 10 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.