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NMDA receptor modulator
Drug: NRX-1074 375 mg for Depression (NRX-1074 Trial)
Phase 1
Waitlist Available
Led By Mimi Van Der Leden, MD, PhD
Research Sponsored by Naurex, Inc, an affiliate of Allergan plc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up for 24 hours after drug dose on day 1
Awards & highlights
NRX-1074 Trial Summary
The purpose of this study is to assess the safety and tolerability of multiple oral (PO) ascending doses of NRX-1074 in normal healthy volunteers.
Eligible Conditions
- Depression
NRX-1074 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ for 24 hours after drug dose on day 7
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for 24 hours after drug dose on day 7
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with adverse events as a measure of safety and tolerability
Secondary outcome measures
Plasma pharmacokinetics - Tmax
Plasma pharmacokinetics Cmax
NRX-1074 Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Drug: NRX-1074 750 mgExperimental Treatment1 Intervention
Single oral administration on Day 1
Group II: Drug: NRX-1074 500 mgExperimental Treatment1 Intervention
Single oral administration on Day 1
Group III: Drug: NRX-1074 375 mgExperimental Treatment1 Intervention
Single oral administration on Day 1
Group IV: Drug: PlaceboPlacebo Group1 Intervention
Single oral administration on Day 1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NRX-1074
Not yet FDA approved
NRX-1074
Not yet FDA approved
NRX-1074
Not yet FDA approved
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Naurex, Inc, an affiliate of Allergan plcLead Sponsor
22 Previous Clinical Trials
6,069 Total Patients Enrolled
16 Trials studying Depression
5,615 Patients Enrolled for Depression
Mimi Van Der Leden, MD, PhDPrincipal InvestigatorChicago Research Center, Inc.
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