Safety and Tolerability of GATE-251 in Normal Human Volunteers

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04981561
• Other study ID #: 3125-101-009
• Status: Completed
• Phase: Phase 1
• Start date: December 9, 2016
• Est. completion date: December 21, 2017

Study information

• Verified date: July 2021
• Source: Gate Neurosciences, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 21, 2017
• Est. primary completion date: December 21, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• GATE-251
Single dose of GATE-251
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ronald M Burch MD PhD

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment emergent adverse events	through study completion	28 days
Secondary	Pharmacokinetics, maximum plasma concentration	maximum plasma concentration	24 hours
Secondary	Pharmacokinetics, time to maximum plasma concentration	time to maximum plasma concentration	24 hours
Secondary	Pharmacokinetics, area under the curve for plasma concentration	area under the curve, plasma calculated 0-infinity	72 hours