Safety and Tolerability of GATE-251 in Normal Human Volunteers
- Registration Number
- NCT04981561
- Lead Sponsor
- Ronald M Burch MD PhD
- Brief Summary
To evaluate the safety and tolerability of single ascending doses of GATE-251 in normal human volunteers
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 100 mg GATE-251 GATE-251 GATE-251, 100 mg tablet, PO, Single Dose with 28 day follow up Placebo Placebo Placebo tablet, PO, Single Dose with 28 day follow up 25 mg GATE-251 GATE-251 GATE-251, 25 mg tablet, PO, Single Dose with 28 day follow up 100 microgram GATE-251 GATE-251 GATE-251, 100 microgram tablet, PO, Single Dose with 28 day follow up 10 mg GATE-251 GATE-251 GATE-251, 10 mg tablet, PO, Single Dose with 28 day follow up 1 mg GATE-251 GATE-251 GATE-251, 1 mg tablet, PO, Single Dose with 28 day follow up 3 mg GATE-251 GATE-251 GATE-251, 3 mg tablet, PO, Single Dose with 28 day follow up 50 mg GATE-251 GATE-251 GATE-251, 50 mg tablet, PO, Single Dose with 28 day follow up 1 mg GATE-251 with CSF collection GATE-251 GATE-251, 1 mg tablet, PO, Single Dose with 28 day follow up, with CSF collection 10 mg GATE-251 with CSF collection GATE-251 GATE-251, 10 mg tablet, PO, Single Dose with 28 day follow up, with CSF collection
- Primary Outcome Measures
Name Time Method Treatment emergent adverse events 28 days through study completion
- Secondary Outcome Measures
Name Time Method Pharmacokinetics, area under the curve for plasma concentration 72 hours area under the curve, plasma calculated 0-infinity
Pharmacokinetics, maximum plasma concentration 24 hours maximum plasma concentration
Pharmacokinetics, time to maximum plasma concentration 24 hours time to maximum plasma concentration