Safety and Tolerability of GATE-251 in Normal Human Volunteers

Sponsor

Ronald M Burch MD PhD (Industry)

Overall Status

Completed

CT.gov ID

NCT04981561

Collaborator

(none)

Enrollment

Arms

12.4

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Drug: GATE-251 Drug: Placebo	Phase 1

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

Study Design

Study Type:

Interventional

Actual Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Double blind placebo controlledDouble blind placebo controlled

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

Triple blind

Primary Purpose:

Treatment

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

Actual Study Start Date :

Dec 9, 2016

Actual Primary Completion Date :

Dec 21, 2017

Actual Study Completion Date :

Dec 21, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 100 microgram GATE-251 GATE-251, 100 microgram tablet, PO, Single Dose with 28 day follow up	Drug: GATE-251 Single dose of GATE-251
Experimental: 1 mg GATE-251 GATE-251, 1 mg tablet, PO, Single Dose with 28 day follow up	Drug: GATE-251 Single dose of GATE-251
Experimental: 3 mg GATE-251 GATE-251, 3 mg tablet, PO, Single Dose with 28 day follow up	Drug: GATE-251 Single dose of GATE-251
Experimental: 10 mg GATE-251 GATE-251, 10 mg tablet, PO, Single Dose with 28 day follow up	Drug: GATE-251 Single dose of GATE-251
Experimental: 25 mg GATE-251 GATE-251, 25 mg tablet, PO, Single Dose with 28 day follow up	Drug: GATE-251 Single dose of GATE-251
Experimental: 50 mg GATE-251 GATE-251, 50 mg tablet, PO, Single Dose with 28 day follow up	Drug: GATE-251 Single dose of GATE-251
Experimental: 100 mg GATE-251 GATE-251, 100 mg tablet, PO, Single Dose with 28 day follow up	Drug: GATE-251 Single dose of GATE-251
Experimental: 1 mg GATE-251 with CSF collection GATE-251, 1 mg tablet, PO, Single Dose with 28 day follow up, with CSF collection	Drug: GATE-251 Single dose of GATE-251
Experimental: 10 mg GATE-251 with CSF collection GATE-251, 10 mg tablet, PO, Single Dose with 28 day follow up, with CSF collection	Drug: GATE-251 Single dose of GATE-251
Placebo Comparator: Placebo Placebo tablet, PO, Single Dose with 28 day follow up	Drug: Placebo Placebo

Outcome Measures

Primary Outcome Measures

Treatment emergent adverse events [28 days]
through study completion

Secondary Outcome Measures

Pharmacokinetics, maximum plasma concentration [24 hours]
maximum plasma concentration
Pharmacokinetics, time to maximum plasma concentration [24 hours]
time to maximum plasma concentration
Pharmacokinetics, area under the curve for plasma concentration [72 hours]
area under the curve, plasma calculated 0-infinity

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Ronald M Burch MD PhD

Investigators

Study Director: Ronald M Burch, MD PhD, Gate Neurosciences, Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ronald M Burch MD PhD, Chief Medical Officer, Gate Neurosciences, Inc

ClinicalTrials.gov Identifier:

NCT04981561

Other Study ID Numbers:

3125-101-009

First Posted:

Jul 29, 2021

Last Update Posted:

Jul 29, 2021

Last Verified:

Jul 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ronald M Burch MD PhD, Chief Medical Officer, Gate Neurosciences, Inc

NMDA receptor

NMDA receptor positive allosteric modulator

pharmacokinetics

biomarker

eeg

Additional relevant MeSH terms:

Depressive Disorder

Depressive Disorder, Major

Study Results

No Results Posted as of Jul 29, 2021