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

Healthy Volunteers Clinical Trial

— PK400 INFS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01497288
• Other study ID #: FT-1301-101-RD
• Secondary ID: 2011-002549-37U1
• Status: Completed
• Phase: Phase 1
• First received: December 8, 2011
• Last updated: September 28, 2012
• Start date: November 2011
• Est. completion date: December 2011

Study information

• Verified date: September 2012
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• INFS (Intranasal Fentanyl Spray)
Intranasal Fentanyl Spray

Locations

Country	Name	City	State
Germany	Nycomed Investigational Site	Mannheim

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No