Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INFS · 1 trial · 1 indication
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 \[clearance (CL), absorption rate constant (KA), central volume (V2), and bioavailability (F1)\].
| Arm | Type | Description |
|---|---|---|
| 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) |
| 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) |
| Name | Type | Description |
|---|---|---|
| INFS (Intranasal Fentanyl Spray) | DRUG | Intranasal Fentanyl Spray |
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.
INFS is an intranasal fentanyl spray being studied for use in healthy volunteers. It is a small molecule in Phase 1 clinical development, and the completed trial investigated its pharmacokinetics after single doses of 200 µg, 400 µg, and 2 x 400 µg.
INFS is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The drug is currently in Phase 1 clinical development.
INFS is in Phase 1 clinical development. It is an investigational drug, not yet approved, and has completed one Phase 1 trial in healthy volunteers.
INFS has one completed clinical trial, NCT01497288, titled '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.' This Phase 1 trial enrolled 20 participants in Germany.
INFS is an intranasal fentanyl spray, meaning it is a formulation of fentanyl delivered through the nose. It is being studied as a small molecule in healthy volunteers, but it is not the same as other fentanyl products.