Trial | NCT04981561  Report issue

Title

Safety and Tolerability of GATE-251 in Normal Human Volunteers
A Phase 1, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AGN-241751 After Oral Administration in Healthy Volunteers

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    GATE-251 ...

  • Study Participants

    68
To evaluate the safety and tolerability of single ascending doses of GATE-251 in normal human volunteers
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
Study Started
Dec 09
2016
Primary Completion
Dec 21
2017
Study Completion
Dec 21
2017
Last Update
Jul 29
2021

Drug GATE-251

Single dose of GATE-251

Drug Placebo

Placebo

100 microgram GATE-251 Experimental

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

1 mg GATE-251 Experimental

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

3 mg GATE-251 Experimental

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

10 mg GATE-251 Experimental

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

25 mg GATE-251 Experimental

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

50 mg GATE-251 Experimental

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

100 mg GATE-251 Experimental

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

1 mg GATE-251 with CSF collection Experimental

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

10 mg GATE-251 with CSF collection Experimental

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

Placebo Placebo Comparator

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

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
No Results Posted