Safety, Tolerability, PK of Oral NYX-2925 in Healthy Volunteers

Healthy Volunteers Clinical Trial

Official title: A Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Daily Oral NYX2925 in Healthy Volunteers

Status Completed

Clinical Trial Summary

This is a first in human study of NYX-2925. It will evaluate single and multiple ascending doses of NYX-2925 in healthy volunteers.

Clinical Trial Description

This is a first in human study of NYX-2925. This is a randomized, double-blind, sponsor-open, placebo-controlled, single and multiple ascending dose, parallel safety, tolerability, and PK study of oral NYX-2925 in healthy volunteers. The single ascending dose phase will comprise up to five dose groups. There will be up to 3 dose groups in the multiple ascending dose phase. One open-label dose group will be repeated in the multiple ascending dose phase to collect cerebrospinal fluid (CSF) samples, in order to explore central nervous system penetration. One elderly cohort (single dose) will be completed after all single and multiple dose escalation groups have completed. One open-label dose group will be repeated in the single ascending dose phase to collect CSF samples, in order to establish a more complete cerebral spinal fluid pharmacokinetic profile.

The influence of food ("food effect") on the bioavailability and pharmacokinetics of NYX-2925 will be explored in one dose group in the single ascending dose phase.

A data review committee will review safety and tolerability (adverse events and other relevant data), plus preliminary pharmacokinetic data, prior to proceeding to the next higher dose group, cohort, and/or phase of the study, as well as administration of the fed dose in the food effect group.

Stopping rules for individual study participants and dose groups or cohorts are established in order to evaluate the dose escalation scheme, the need to stop or terminate dosing, or to establish the maximum tolerated dose. If a cohort is stopped due to safety or tolerability concerns, the previous cohort may be repeated to determine the highest tolerated dose. ;

Related Conditions & MeSH terms

• Healthy Volunteers

• NCT number: NCT02834741
• Study type: Interventional
• Source: Aptinyx
• Status: Completed
• Phase: Phase 1
• Start date: July 2016
• Completion date: March 2017