Safety and Tolerability of GATE-251 in Normal Human Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-09

Study Completion Date

2017-12-21

Brief Summary

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

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Detailed Description

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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

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blind placebo controlled

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Triple blind

Study Groups

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100 microgram GATE-251

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

Group Type EXPERIMENTAL

GATE-251

Intervention Type DRUG

Single dose of GATE-251

1 mg GATE-251

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

Group Type EXPERIMENTAL

GATE-251

Intervention Type DRUG

Single dose of GATE-251

3 mg GATE-251

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

Group Type EXPERIMENTAL

GATE-251

Intervention Type DRUG

Single dose of GATE-251

10 mg GATE-251

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

Group Type EXPERIMENTAL

GATE-251

Intervention Type DRUG

Single dose of GATE-251

25 mg GATE-251

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

Group Type EXPERIMENTAL

GATE-251

Intervention Type DRUG

Single dose of GATE-251

50 mg GATE-251

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

Group Type EXPERIMENTAL

GATE-251

Intervention Type DRUG

Single dose of GATE-251

100 mg GATE-251

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

Group Type EXPERIMENTAL

GATE-251

Intervention Type DRUG

Single dose of GATE-251

1 mg GATE-251 with CSF collection

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

Group Type EXPERIMENTAL

GATE-251

Intervention Type DRUG

Single dose of GATE-251

10 mg GATE-251 with CSF collection

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

Group Type EXPERIMENTAL

GATE-251

Intervention Type DRUG

Single dose of GATE-251

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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GATE-251

Single dose of GATE-251

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes