NCT05503511

Safety and Pharmacokinetic Study of NPT 2042 Soft-gelatin Capsules Administered Orally to Healthy Adult Subjects

A Single-center, Randomized, Placebo Controlled, Double-blind, Ascending Single-dose and Repeated-dose Trial to Determine the Safety and Pharmacokinetic Profile of NPT 2042 Soft-Gelatin Capsules Administered Orally to Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: NeuroPro Therapeutics, Inc. · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Study NPT 2042 CL 101 is a first in human (FIH) study to evaluate the safety and pharmacokinetics (PK) of single and repeated ascending doses of NPT 2042 in healthy adult male and female subjects.

Detailed description

The long-term goal of this program is to develop NPT 2042 an adjunct antiseizure treatment for patients with medically intractable epilepsy. Prior to evaluating efficacy in the intended patient population, safety and pharmacokinetics of NPT 2042 will be investigated.

Conditions

• Epilepsy
• Alzheimer Disease
• Epilepsy Intractable

Interventions

Type	Name	Description
DRUG	NPT 2042 (bumetanide analog) or Matching Placebo	Soft gelatin capsules

Timeline

• Start date: 2022-10-20
• Primary completion: 2023-03-17
• Completion: 2023-03-30
• First posted: 2022-08-16
• Last updated: 2023-04-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study