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 (PK400 INFS)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Takeda Global Research & Development Center, Inc. ( Nycomed: A Takeda Company )

ClinicalTrials.gov Identifier:

NCT01497288

First received: December 8, 2011

Last updated: September 28, 2012

Last verified: September 2012

History of Changes

Purpose

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.

Condition	Intervention	Phase
Healthy Volunteers	Drug: INFS (Intranasal Fentanyl Spray)	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Drug Information available for: Fentanyl Fentanyl citrate

U.S. FDA Resources

Further study details as provided by Takeda Global Research & Development Center, Inc.:

Primary Outcome Measures:

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] [ Time Frame: Blood sampling for PK will be performed until 72 hours after the first treatment administration ] [ Designated as safety issue: No ]
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)].

Estimated Enrollment:	20
Study Start Date:	November 2011
Study Completion Date:	December 2011
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Sequence 1 (A-B-C) 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) Intranasal Fentanyl Spray Other Name: (Instanyl®)
Experimental: Sequence 2 (A-C-B) 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) Intranasal Fentanyl Spray Other Name: (Instanyl®)

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01497288

Locations

Germany
Nycomed Investigational Site
Mannheim, Germany, 68157

Sponsors and Collaborators

Nycomed: A Takeda Company

More Information

No publications provided

Responsible Party:	Takeda Global Research & Development Center, Inc. ( Nycomed: A Takeda Company )
ClinicalTrials.gov Identifier:	NCT01497288 History of Changes
Other Study ID Numbers:	FT-1301-101-RD, 2011-002549-37, U1111-1135-2623
Study First Received:	December 8, 2011
Last Updated:	September 28, 2012
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Takeda Global Research & Development Center, Inc.:

Intranasal fentanyl spray
Population PK

Additional relevant MeSH terms:

Fentanyl
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs

Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 19, 2013

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