None listed
Conditions
Brief summary
To characterize the pharmacokinetics (PK), safety, and tolerability of sublingually administered esketamine hydrochloride from IPX237 at two dose strengths, and to evaluate the effect of formulation retention in the sublingual space.
Interventions
Single-center, open-label, randomized, single-dose, 4-sequence, 4-treatment crossover study with at least 5 days of washout between dosing in each treatment period.
Subjects will be randomized to one of four sequences to receive the following investigational treatments under fasted condition:
Treatment A: IPX237-L0003 sublingual paste (0.42 mL)90 mg, retained under the tongue for 2 minutes.
Treatment B: IPX237-L0003 sublingual paste (0.42 mL) 90mg, no restriction on retention or swallowing.
T
Single-center, open-label, randomized, single-dose, 4-sequence, 4-treatment crossover study with at least 5 days of washout between dosing in each treatment period. Subjects will be randomized to one of four sequences to receive the following investigational treatments under fasted condition: Treatment A: IPX237-L0003 sublingual paste (0.42 mL)90 mg, retained under the tongue for 2 minutes. Treatment B: IPX237-L0003 sublingual paste (0.42 mL) 90mg, no restriction on retention or swallowing. Treatment C: IPX237-L0002 sublingual paste (0.42 mL)45mg, retained under the tongue for 2 minutes. Treatment D: 15 mg esketamine (free base equivalent), preservative-free, infused IV over 40 minutes. The sublingual paste must be placed under the tongue using the prefilled applicator. Proper administration of the sublingual drug products should be confirmed by a mouth check. Subjects must not expectorate, drink, or rinse the mouth for at least 1 hour postdose. The subject should be evaluated at 32 hours postdose to determine that they are medically stable. The subject should be driven home by a responsible adult.
Sponsors
Impax Pharmaceuticals,A Division of Impax Laboratories, Inc.
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy volunteers between the ages of 18 and 55 years of age inclusive, weighing at least 60 kg with BMI of 18.0 kg/m2 to 29.5 kg/m2 (inclusive) at the time of informed consent.
Exclusion criteria
Presence of a clinically significant disorder, including acute or chronic infections or a malignant neoplasm and/or involving disease in one or more of these organ systems: cardiovascular, respiratory, renal, gastrointestinal, immunologic, musculoskeletal, hematologic, dermatologic, hepatic, reproductive, endocrine, or neurologic/psychiatric, as determined by clinical investigators. History of psychosis in self or family. History of or clinical signs of glaucoma. History of or clinical signs of any form of epilepsy or seizures
Outcome results
None listed