A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Food Effect of JZP047 in Healthy Participants

NCT07377539 | Recruiting Phase 1 FDA Drug

• 1 other identifier: JZP047-101
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 1, double-blind, sponsor-unblinded, randomized, placebo-controlled study designed to characterize the safety, tolerability, and PK of JZP047 in healthy participants following single-ascending doses of study intervention. Additionally, the effect of food on PK following a single dose of JZP047 will be assessed through comparison of PK between the fed and fasted states.

Conditions

Healthy Participants

Keywords

Healthy Participants; JZP047

Outcome Measures

Primary Outcomes (12)

• 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)

  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.

  Up to 90 days

• 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

Secondary Outcomes (4)

• Dose Proportionality of JZP047 Cmax (Part A)

  Up to 90 days

• Dose Proportionality of JZP047 AUC0-last and AUC∞

  Up to 90 days

• The Effect of Food On The Single Dose PK of JZP047 Cmax

  Up to 90 days

• The Effect of Food On The Single Dose PK of JZP047 AUC0-last and AUC∞

  Up to 90 days

Study Arms (3)

Part A: JZP047

EXPERIMENTAL

Healthy participants who are randomized to JZP047.

Drug: JZP047

Part A: Placebo

PLACEBO COMPARATOR

Healthy participants who are randomized to placebo.

Other: Placebo

Part B: JZP047

EXPERIMENTAL

Healthy participants who will receive JZP047.

Drug: JZP047

Interventions

JZP047 DRUG

Single dose

Part A: JZP047; Part B: JZP047

Placebo OTHER

Single dose

Part A: Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Participants are eligible to be included in the study only if all of the following criteria apply: 1. Healthy participants 18 to 55 years of age, willing and able to comply with study requirements. 2. Male participants are eligible to participate if they agree to the following during the study intervention period and for at least 120 days after the last dose of study intervention: * Refrain from donating sperm. * Use contraception/barrier as follows: * Use a male condom with female partner and use of an additional highly effective contraceptive method with a failure rate of \< 1% per year and should also be advised of the benefit of a female partner using a highly effective method of contraception, as a condom may break or leak, when having sexual intercourse with a woman of childbearing potential (WOCBP) who is currently not pregnant. * Agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person. 3. Female participants are eligible to participate if: * She is a woman of nonchildbearing potential (WONCBP). * Pregnancy testing will be performed prior to administration of study intervention to confirm female participants are not pregnant. Participants are excluded from the study if any of the following criteria apply: 1. History of or presence of clinically significant medical illness or disorder or have a medical issue that may interfere with absorption, distribution, metabolism, or excretion of drugs.. 2. History or presence of clinically significant allergy (other than seasonal allergies that do not require treatment during the study) or clinically significant allergy to adhesive bandages, adhesive dressing, ECG patches, or medical tape. 3. History (within 5 past years) or presence of a diagnosis of alcohol abuse, a substance abuse disorder, known drug dependence, or seeking of treatment for an alcohol- or substance abuse-related disorder. 4. Current diagnosis of or receiving treatment for depression; past (within 5 years) clinically significant major depressive episode. 5. History of suicide attempt, current suicidal risk as determined from history, or presence of active suicidal ideation. 6. Presence of any other condition that will cause a risk to participants if they participate in the study as determined by the investigator. 7. Poor peripheral venous access or history of fainting (or passing out) during blood draws. 8. Use or intent to use any prescription medications or nonprescription drugs (including vitamins, recreational drugs, and dietary or herbal supplements) within 14 days or for 5 half-lives, whichever is longer prior to Check-in and throughout the conduct of the study.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead
• Jazz Pharmaceuticals Ireland Limited: collaborator

Study Sites (1)

Celerion, Inc.

Lincoln, Nebraska, 68502, United States

RECRUITING

Central Study Contacts

Clinical Trial Disclosure & Transparency

CONTACT

215-832-3750; ClinicalTrialDisclosure@JazzPharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: January 30, 2026
• Study Start: February 3, 2026
• Primary Completion (Estimated): July 5, 2026
• Study Completion (Estimated): July 5, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)