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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: INFS (Intranasal Fentanyl Spray)

• Registration Number: NCT01497288
• Lead Sponsor: Takeda

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Study First Submitted: 2011-12-08
• Study First Submitted QC: 2011-12-21
• Study First Posted: 2011-12-22
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-28
• Last Update Posted: 2012-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 1 (A-B-C)	INFS (Intranasal Fentanyl Spray)	* 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)
Sequence 2 (A-C-B)	INFS (Intranasal Fentanyl Spray)	* 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)

Primary Outcome Measures

Name	Time	Method
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)]	Blood sampling for PK will be performed until 72 hours after the first treatment administration	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 \[clearance (CL), absorption rate constant (KA), central volume (V2), and bioavailability (F1)\].

Trial Locations

Locations (1)

Nycomed Investigational Site; 🇩🇪 Mannheim, Germany