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A Safety Study of PTI-125 in Healthy Volunteers

NCT03784300 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-05-10

Study results available
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Summary

A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose, Pharmacokinetic and Safety Study of PTl-125 in Healthy Volunteers

Conditions

  • Alzheimer Disease, Early Onset
  • Alzheimer Disease

Interventions

DRUG

50 mg PTI-125

PTI-125 50 mg Oral Solution

DRUG

100 mg PTI-125

PTI-125 100 mg Oral Solution

DRUG

200 mg PTI-125

PTI-125 200 mg Oral Solution

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • Pain Therapeutics

    lead INDUSTRY

Principal Investigators

  • George J Atiee, MD · Worldwide Clinical Trials

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-18
Primary Completion
2017-10-09
Completion
2018-03-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03784300 on ClinicalTrials.gov