A Study of JZP047 in Healthy Participants
This study is looking at a drug called JZP047. It aims to understand how safe JZP047 is, how well your body tolerates it, and how your body processes it (pharmacokinetics or PK). Researchers will also see how food affects JZP047 in your body. You might be eligible if you are a healthy person between 18 and 55 years old. The main goals are to track any side effects and how many people leave the study. This study is currently unclear on its recruitment status and plans to enroll 86 participants.
- Study design
- This is a Phase 1 study, meaning it's an early-stage study in humans. It is designed as a randomized, placebo-controlled study, with some parts being double-blind (neither you nor the study staff know if you're getting JZP047 or a placebo) and other parts open-label (everyone knows what you're getting).
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- You would be followed for up to 90 days after your last dose of the study intervention to monitor for any side effects.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of JZP047 in Healthy Participants
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Number of Participants Reporting Treatment-emergent Adverse Events (Part A)Baseline up to Day 90
- Number of Participants Reporting Treatment-emergent Adverse Events (Part B)Baseline up to Day 90
- Number of Participants Who Discontinued The Study (Part A)Baseline up to Day 90
- Number of Participants Who Discontinued The Study (Part B)Baseline up to Day 90
- Pharmacokinetic Parameter Maximum Concentration (Part A)Up to 90 days
- Pharmacokinetic Parameter Time to Maximum Concentration and Time Before the Start of Absorption (Part A)Up to 90 days
- Pharmacokinetic Parameter Terminal Elimination Half-life (Part A)Up to 90 days
- Pharmacokinetic Parameter Terminal Elimination Rate Constant (Part A)Up to 90 days
- Pharmacokinetic Parameter Volume of Distribution During Terminal Phase (Part A)Up to 90 days
- Pharmacokinetic Parameter Oral Clearance (Part A)Up to 90 days
- Pharmacokinetic Parameter Area Under the Concentration-Time Curve (Part A)Up to 90 days
Area under the concentration-time curve from time 0 to 24 (AUC0-24), 0 to last measurable concentration (AUClast), and 0 to infinity (AUC∞) will be assessed.
- Pharmacokinetic Parameter Percentage of The Area Under the Concentration-Time Curve From Time Infinity Due to Extrapolation From The Last Quantifiable Concentration to Time Infinity (Part A)Up to 90 days