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

NCT01497288 | Completed Phase 1

• 3 other identifiers: FT-1301-101-RD2011-002549-37U1111-1135-2623
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Intranasal fentanyl spray; Population PK

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Sequence 1 (A-B-C)

EXPERIMENTAL

* 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)

Sequence 2 (A-C-B)

EXPERIMENTAL

* 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)

Interventions

INFS (Intranasal Fentanyl Spray) DRUG

Intranasal Fentanyl Spray

Also known as: (Instanyl®)

Sequence 1 (A-B-C); Sequence 2 (A-C-B)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Nycomed Investigational Site

Mannheim, 68157, Germany

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2011
• First Posted: December 22, 2011
• Study Start: November 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: October 2, 2012

Record last verified: 2012-09

Locations

DE (1)