NCT03187301

A Cardiac Safety Study of an Investigational Drug to See How if Affects the Heart in People With Parkinson's Disease Complicated by Motor Fluctuations "OFF" Episodes

A Phase 2, Randomized, Double-Blind, Placebo Controlled, 3-Period Crossover, Positive Control, QT-Evaluation Study of APL-130277 in Subjects With Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A cardiac safety study of an investigational drug to see how it affects the heart in people with Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes)

Detailed description

This multi-center, Phase 2, Randomized, Double-Blind, Placebo Controlled, 3-Period Crossover, Positive Control study designed to evaluate the QT interval prolongation potential of 10 mg to 60 mg doses of APL-130277 compared to placebo and the positive control, 400mg moxifloxacin in subjects with Parkinson's Disease (PD) who experience motor fluctuations ("OFF" episodes) The patient is titrated to the highest tolerated dose from 10mg to 60mg, and then is randomized to one of six crossover sequences. Each sequence includes treatment with the following: 1. Treatment A: APL-130277 at the dose determined in the Dose Titration Phase, 2. Treatment B: Matched placebo, 3. Treatment C: A single 400 mg dose of moxifloxacin

Conditions

• Parkinson's Disease
• Off Episodes of Parkinson Disease

Interventions

Type	Name	Description
DRUG	APL-130277	APL-130277 single dose
DRUG	Placebo	Placebo single dose
DRUG	Moxifloxacin	moxifloxacin 400mg single dose

Timeline

• Start date: 2017-08-03
• Primary completion: 2017-12-21
• Completion: 2017-12-21
• First posted: 2017-06-14
• Last updated: 2020-08-10
• Results posted: 2020-08-10

Locations

15 sites across 2 countries: United States, Italy

Regulatory

• FDA-regulated drug study