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
Overview
- Phase
- Phase 1
- Intervention
- INFS (Intranasal Fentanyl Spray)
- Conditions
- Healthy Volunteers
- Sponsor
- Takeda
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)]
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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)
Intervention: INFS (Intranasal Fentanyl Spray)
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)
Intervention: INFS (Intranasal Fentanyl Spray)
Outcomes
Primary Outcomes
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 \[clearance (CL), absorption rate constant (KA), central volume (V2), and bioavailability (F1)\].