Evaluation of the Pharmacokinetics of IPX237 Formulations in Healthy Volunteers
Phase 1
Completed
- Conditions
- DepressionMental Health - Depression
- Registration Number
- ACTRN12613001097730
- Lead Sponsor
- Impax Pharmaceuticals, A Division of Impax Laboratories, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Healthy volunteers between the ages of 18 and 55 years of age inclusive and weighing at least 60 kg 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, 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetics[During each treatment period, blood samples will be collected for measurement of esketamine and potential metabolites in plasma at the following times: within 60 minutes predose, and postdose at 10, 20, 30, 40, and 50 minutes and 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hours. Saliva samples will be collected at Check-in, and postdose at 40 minutes, 6 hours, 12 hours, and 24 hours for potential analysis of esketamine and its metabolites.]
- Secondary Outcome Measures
Name Time Method Safety[Three serial 12-lead electrocardiograms (ECG), clinical laboratory tests, vital signs, adverse events (AEs), and concomitant medications will be evaluated over the course of the study. Physical examinations will be performed at Screening and at Study Exit. Three serial ECGs will be evaluated in each treatment period at Screening, predose, and at 45 minutes, 8, and 24 hours postdose. Telemetry will be obtained from 1 hour predose to 8 hours postdose. Vital signs will be measured in each period as specified. Psychiatric effects and dissociative symptoms will be assessed at specified times postdose by the Brief Psychiatric Rating Scale (BPRS) and dissociative symptoms will be gauged by the Clinician-Administered Dissociative States Rating Scale (CADSS). ]