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| Name | Class |
|---|---|
| Jazz Pharmaceuticals Ireland Limited | INDUSTRY |
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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.
The study will consist of 2 parts: a single-dose ascending part (Part A [SAD] and a single dose under fed conditions part (Part B [Fed PK]).
The study design for Part A will be double-blind, sponsor-unblinded, randomized, and placebo-controlled. Part B, the single dose under fed conditions, will have an open-label study design.
Part A will characterize safety, tolerability, and PK following single doses of JZP047 and matching placebo in healthy male and female participants. Part B will explore the effect of food on a single dose of JZP047 in healthy male and female participants in the fed state.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: JZP047 | Experimental | Healthy participants who are randomized to JZP047. |
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| Part A: Placebo | Placebo Comparator | Healthy participants who are randomized to placebo. |
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| Part B: JZP047 | Experimental | Healthy participants who will receive JZP047. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JZP047 | Drug | Single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Participants are eligible to be included in the study only if all of the following criteria apply:
Healthy participants 18 to 55 years of age, willing and able to comply with study requirements.
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:
Female participants are eligible to participate if:
Participants are excluded from the study if any of the following criteria apply:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosure & Transparency | Contact | 215-832-3750 | ClinicalTrialDisclosure@JazzPharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion, Inc. | Recruiting | Lincoln | Nebraska | 68502 | United States |
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| Placebo |
| Other |
Single dose |
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| 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 |
| Up to 90 days |
| The Effect of Food On The Single Dose PK of JZP047 AUC0-last and AUC∞ | Up to 90 days |