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)

September 28, 2012 updated by: Takeda

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Mannheim, Germany, 68157
        • Nycomed Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • (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 Names:
  • (Instanyl®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

December 8, 2011

First Submitted That Met QC Criteria

December 21, 2011

First Posted (Estimate)

December 22, 2011

Study Record Updates

Last Update Posted (Estimate)

October 2, 2012

Last Update Submitted That Met QC Criteria

September 28, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FT-1301-101-RD
  • 2011-002549-37 (EudraCT Number)
  • U1111-1135-2623 (Registry Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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