Health TrialsbyHealthPanel

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JZP269 in Healthy Male and Female Participants

ConditionHealthy Participants
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorJazz Pharmaceuticals

About this trial

This study will characterize the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) of JZP269 in healthy participants.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Is 18 to 55 years of age, inclusive, at the time of signing the informed consent.

Is overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac/blood pressure monitoring.

Has a body weight of at least 45 kg and BMI within the range of 18.5 to 30 kg/m² (inclusive).

Has a history of or presence of clinically significant medical illness as specified in the protocol.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • JZP269

    Drug

    Administered as described.

  • Placebo

    Drug

    Administered as described.

Treatment groups

188 Participants
are divided into 2 treatment groups
Group A: JZP269Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants Reporting Treatment-emergent Adverse Events

Time frame
Day 1 of dosing and monitoring period up to 7 days after last dose (Safety Follow Up Visit)
2

Pharmacokinetic Parameter Maximum Concentration (Cmax) of JZP269

Time frame
Predose up to 48 hours postdose
3

Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) of JZP269

Time frame
Predose up to 48 hours postdose
4

Pharmacokinetic Parameter Apparent Terminal Elimination Half-life (t1/2) of JZP269

Time frame
Predose up to 48 hours postdose

Secondary outcomes

1

Dose Proportionality of JZP269 Area Under the Concentration-Time Curve (AUC)

Dose proportionality of JZP269 AUC0-last, AUC∞, and AUC0-24 will be assessed.

Time frame
Predose up to 48 hours postdose
2

Dose Proportionality of JZP269 Maximum Concentration (Cmax)

Time frame
Predose up to 48 hours postdose
3

The Effect of Food on the PK of JZP269 Cmax

The effect of food on the PK of JZP269 relative to that observed in the fasted state will be assessed.

Time frame
Predose up to 48 hours postdose
4

The Effect of Food on the PK of JZP269 Tmax

The effect of food on the PK of JZP269 relative to that observed in the fasted state will be assessed.

Time frame
Predose up to 48 hours postdose

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jazz Pharmaceuticals

Lead sponsor

Jazz Pharmaceuticals Ireland Limited

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: