A Trial to Investigate the Pharmacokinetics (PK) of Single Doses of 200 µg, 400 µg and 2 x 400 µg of Intranasal Fentanyl Spray (INFS) in Healthy Subjects

Study Overview
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Brief Summary
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The overall clinical trial objective is to gain information about the Pharmacokinetics (PK) of a 400 µg dose strength of INFS using a Population PK (PopPK). In total, 20 healthy male and female subjects are planned to be randomized in the trial. Subjects will be randomized to one of two treatment sequences and treated with 3 different dosages (either 200 µg/dose INFS, 400 µg/dose or 400 µg two doses administered 10 minutes apart) over two days. Subjects will be hospitalized over a period of total 5 days, where safety assessments and pharmacokinetic samplings will be conducted.

Official Title
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An Open Label, Randomised, Single-centre, Two Sequence, Cross-over Trial to Investigate the Pharmacokinetics (PK) of Single Doses of 200 µg, 400 µg and 2 x 400 µg of Intranasal Fentanyl Spray (INFS) in Healthy Subjects Using a Population PK Approach

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: INFS (Intranasal Fentanyl Spray)


Participation Criteria
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Eligibility Criteria
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Eligibility Criteria: Healthy male and female Caucasian or Black subjects between 18 and 55 years with a body mass index of 18-28 kg/m2 and a minimum weight of 50 kg.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1 (A-B-C)<br>A: single dose of 200 μg INFS (100 μL) (Instanyl®), administered on Day 1 B: single dose of 400 μg INFS (100 μL), administered 4 hours after the first treatment C: two single doses of 400 μg INFS (100 μL) (10 min apart), administered 24 hours after the first treatment (Day 2) | Drug: INFS (Intranasal Fentanyl Spray)<br>* Intranasal Fentanyl Spray<br>* Other names: (Instanyl®);|
| Experimental: Sequence 2 (A-C-B)<br>A: single dose of 200 μg INFS (100 μL) (Instanyl®), administered on Day 1 C: two single doses of 400 μg INFS (100 μL) (10 min apart), administered 4 hours after the first treatment B: single dose of 400 μg INFS (100 μL), administered 24 hours after the first treatment (Day 2) | Drug: INFS (Intranasal Fentanyl Spray)<br>* Intranasal Fentanyl Spray<br>* Other names: (Instanyl®);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] | AUC= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from simulated single dose concentration time profiles derived from the final parameters of the PopPK model [clearance (CL), absorption rate constant (KA), central volume (V2), and bioavailability (F1)]. | Blood sampling for PK will be performed until 72 hours after the first treatment administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intranasal fentanyl spray, Population PK