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Safety and Tolerability of GATE-251 in Normal Human Volunteers

Primary Purpose

Major Depressive Disorder

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

GATE-251

Placebo

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring NMDA receptor, NMDA receptor positive allosteric modulator, pharmacokinetics, biomarker, eeg

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Agree to effective method of birth control
If female, negative pregnancy test at screening and Day -1
Nonsmoking at least 2 years
BMI 18-30
Supine pulse rate 30-100

Exclusion Criteria:

Known hypersensitivity to NMDA receptor drugs
clinically significant disease in any body system
QTcF > 430 ms in males, >450 ms in females
positive test for hepatitis B or C
abnormal liver function tests on Day -1
History of alcohol or other substance abuse during the previous 5 years
Positive drug screen at screening or Day -1
Taken any medication within the past 14 days

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Placebo Comparator

Arm Label

100 microgram GATE-251

1 mg GATE-251

3 mg GATE-251

10 mg GATE-251

25 mg GATE-251

50 mg GATE-251

100 mg GATE-251

1 mg GATE-251 with CSF collection

10 mg GATE-251 with CSF collection

Placebo

Arm Description

GATE-251, 100 microgram tablet, PO, Single Dose with 28 day follow up

GATE-251, 1 mg tablet, PO, Single Dose with 28 day follow up

GATE-251, 3 mg tablet, PO, Single Dose with 28 day follow up

GATE-251, 10 mg tablet, PO, Single Dose with 28 day follow up

GATE-251, 25 mg tablet, PO, Single Dose with 28 day follow up

GATE-251, 50 mg tablet, PO, Single Dose with 28 day follow up

GATE-251, 100 mg tablet, PO, Single Dose with 28 day follow up

GATE-251, 1 mg tablet, PO, Single Dose with 28 day follow up, with CSF collection

GATE-251, 10 mg tablet, PO, Single Dose with 28 day follow up, with CSF collection

Placebo tablet, PO, Single Dose with 28 day follow up

Outcomes

Primary Outcome Measures

Treatment emergent adverse events

through study completion

Secondary Outcome Measures

Pharmacokinetics, maximum plasma concentration

maximum plasma concentration

Pharmacokinetics, time to maximum plasma concentration

time to maximum plasma concentration

Pharmacokinetics, area under the curve for plasma concentration

area under the curve, plasma calculated 0-infinity

Full Information

NCT ID

NCT04981561

First Posted

July 18, 2021

Last Updated

July 28, 2021

Sponsor

Ronald M Burch MD PhD

1. Study Identification

Unique Protocol Identification Number

NCT04981561

Brief Title

Safety and Tolerability of GATE-251 in Normal Human Volunteers

Official Title

A Phase 1, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AGN-241751 After Oral Administration in Healthy Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

December 9, 2016 (Actual)

Primary Completion Date

December 21, 2017 (Actual)

Study Completion Date

December 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Ronald M Burch MD PhD

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

To evaluate the safety and tolerability of single ascending doses of GATE-251 in normal human volunteers

Detailed Description

Single ascending dose (SAD), double-blind placebo-controlled study in normal human volunteers. Secondary objectives: To evaluate the pharmacokinetics (PK) and eeg biomarker of target engagement of GATE-251 following increasing single doses of GATE-251. GATE-251 or Placebo: Dose/Mode of Administration: Single dose; oral

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

Keywords

NMDA receptor, NMDA receptor positive allosteric modulator, pharmacokinetics, biomarker, eeg

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

Double blind placebo controlled

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

Triple blind

Allocation

Randomized

Enrollment

68 (Actual)

8. Arms, Groups, and Interventions

Arm Title

100 microgram GATE-251

Arm Type

Experimental

Arm Description

GATE-251, 100 microgram tablet, PO, Single Dose with 28 day follow up

Arm Title

1 mg GATE-251

Arm Type

Experimental

Arm Description

GATE-251, 1 mg tablet, PO, Single Dose with 28 day follow up

Arm Title

3 mg GATE-251

Arm Type

Experimental

Arm Description

GATE-251, 3 mg tablet, PO, Single Dose with 28 day follow up

Arm Title

10 mg GATE-251

Arm Type

Experimental

Arm Description

GATE-251, 10 mg tablet, PO, Single Dose with 28 day follow up

Arm Title

25 mg GATE-251

Arm Type

Experimental

Arm Description

GATE-251, 25 mg tablet, PO, Single Dose with 28 day follow up

Arm Title

50 mg GATE-251

Arm Type

Experimental

Arm Description

GATE-251, 50 mg tablet, PO, Single Dose with 28 day follow up

Arm Title

100 mg GATE-251

Arm Type

Experimental

Arm Description

GATE-251, 100 mg tablet, PO, Single Dose with 28 day follow up

Arm Title

1 mg GATE-251 with CSF collection

Arm Type

Experimental

Arm Description

GATE-251, 1 mg tablet, PO, Single Dose with 28 day follow up, with CSF collection

Arm Title

10 mg GATE-251 with CSF collection

Arm Type

Experimental

Arm Description

GATE-251, 10 mg tablet, PO, Single Dose with 28 day follow up, with CSF collection

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo tablet, PO, Single Dose with 28 day follow up

Intervention Type

Drug

Intervention Name(s)

GATE-251

Intervention Description

Single dose of GATE-251

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Treatment emergent adverse events

Description

through study completion

Time Frame

28 days

Secondary Outcome Measure Information:

Title

Pharmacokinetics, maximum plasma concentration

Description

maximum plasma concentration

Time Frame

24 hours

Title

Pharmacokinetics, time to maximum plasma concentration

Description

time to maximum plasma concentration

Time Frame

24 hours

Title

Pharmacokinetics, area under the curve for plasma concentration

Description

area under the curve, plasma calculated 0-infinity

Time Frame

72 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Agree to effective method of birth control If female, negative pregnancy test at screening and Day -1 Nonsmoking at least 2 years BMI 18-30 Supine pulse rate 30-100 Exclusion Criteria: Known hypersensitivity to NMDA receptor drugs clinically significant disease in any body system QTcF > 430 ms in males, >450 ms in females positive test for hepatitis B or C abnormal liver function tests on Day -1 History of alcohol or other substance abuse during the previous 5 years Positive drug screen at screening or Day -1 Taken any medication within the past 14 days

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ronald M Burch, MD PhD

Organizational Affiliation

Gate Neurosciences, Inc

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

Safety and Tolerability of GATE-251 in Normal Human Volunteers

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