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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:
ClinicalTrials.gov Identifier:
NCT01497288
First Posted: December 22, 2011
Last Update Posted: October 2, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Takeda
  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
Intervention Model: Crossover Assignment
Masking: None (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:


Further study details as provided by Takeda:

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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01497288


Locations
Germany
Nycomed Investigational Site
Mannheim, Germany, 68157
Sponsors and Collaborators
Takeda
  More Information

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01497288     History of Changes
Other Study ID Numbers: FT-1301-101-RD
2011-002549-37 ( EudraCT Number )
U1111-1135-2623 ( Registry Identifier: WHO )
First Submitted: December 8, 2011
First Posted: December 22, 2011
Last Update Posted: October 2, 2012
Last Verified: September 2012

Keywords provided by Takeda:
Intranasal fentanyl spray
Population PK

Additional relevant MeSH terms:
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics