Safety and Tolerability of GATE-251 in Normal Human Volunteers

Gate Neurosciences

Status and phase: Completed; Phase 1

Conditions: Major Depressive Disorder

Treatments: Drug: GATE-251; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04981561

3125-101-009

Details and patient eligibility

About

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

Full 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

Enrollment: 68 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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68 participants in 10 patient groups, including a placebo group

100 microgram GATE-251

Experimental group

Description:

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

Treatment:

Drug: GATE-251

1 mg GATE-251

Experimental group

Description:

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

Treatment:

Drug: GATE-251

3 mg GATE-251

Experimental group

Description:

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

Treatment:

Drug: GATE-251

10 mg GATE-251

Experimental group

Description:

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

Treatment:

Drug: GATE-251

25 mg GATE-251

Experimental group

Description:

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

Treatment:

Drug: GATE-251

50 mg GATE-251

Experimental group

Description:

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

Treatment:

Drug: GATE-251

100 mg GATE-251

Experimental group

Description:

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

Treatment:

Drug: GATE-251

1 mg GATE-251 with CSF collection

Experimental group

Description:

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

Treatment:

Drug: GATE-251

10 mg GATE-251 with CSF collection

Experimental group

Description:

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

Treatment:

Drug: GATE-251

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo