Safety and Tolerability of GATE-251 in Normal Human Volunteers

• Status: Completed
• Trial end date: 2017-12-21
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ronald M Burch MD PhD

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