JZP441 for Healthy Subjects

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Healthy SubjectsJZP441 - Drug
Eligibility
18 - 50
All Sexes
What conditions do you have?
Select

Study Summary

This Phase 1, double-blind, randomized, placebo-controlled study will characterize the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ascending nighttime doses of JZP441 in sleep-deprived healthy participants.

Treatment Effectiveness

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Predose and the following postdose hours: 0.25,0.5,0.75,1,1.5,1.75,2.75,3 and 3.5,3.75,4.75,5 and 5.5,5.75, 6.25 and 6.5,6.75,7 and 7.5,7.75,8.75,9.75,10.75,11.75,12.75,13.75,16,18,24,36

Day 8
Number of Participants With Treatment-emergent Adverse Events After Administration of JZP441 in Sleep-deprived Healthy Participants
Predose and the following postdose hours: 0.25,0.5,0.75,1,1.5,1.75,2.75,3 and 3.5,3.75,4.75,5 and 5.5,5.75, 6.25 and 6.5,6.75,7 and 7.5,7.75,8.75,9.75,10.75,11.75,12.75,13.75,16,18,24,36
Pharmacokinetic Parameter Area Under the Concentration-Time Curve (AUC) of JZP441
Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) Levels of JZP441
Pharmacokinetic Parameter Time to Maximum Plasma Concentration (Tmax) of JZP441

Trial Safety

Trial Design

2 Treatment Groups

JZP441
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

132 Total Participants · 2 Treatment Groups

Primary Treatment: JZP441 · Has Placebo Group · Phase 1

JZP441
Drug
Experimental Group · 1 Intervention: JZP441 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: predose and the following postdose hours: 0.25,0.5,0.75,1,1.5,1.75,2.75,3 and 3.5,3.75,4.75,5 and 5.5,5.75, 6.25 and 6.5,6.75,7 and 7.5,7.75,8.75,9.75,10.75,11.75,12.75,13.75,16,18,24,36

Who is running the clinical trial?

Jazz PharmaceuticalsLead Sponsor
218 Previous Clinical Trials
30,137 Total Patients Enrolled

Eligibility Criteria

Age 18 - 50 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your age at the time of consent is between 18 and 50 years old.
You are medically certified as healthy, based on evaluation of medical history, physical examination and laboratory tests.

Who else is applying?

What state do they live in?
New York33.3%
Connecticut33.3%
New Jersey33.3%
What site did they apply to?
Clinical Site 166.7%
Clinical Site 233.3%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
How many prior treatments have patients received?
0100.0%
Why did patients apply to this trial?
  • "Interested in helping and additional income."
  • "I am a healthy volunteer looking for a source of income during my off season from work."

How responsive is this trial?

Typically responds via
Email100.0%
Most responsive sites:
  1. Clinical Site 2: < 48 hours
Average response time
  • < 2 Days