A Mass Balance Study With a Microtracer Dose of 14C-esketamine in Healthy Male Participants
|ClinicalTrials.gov Identifier: NCT02674295|
Recruitment Status : Completed
First Posted : February 4, 2016
Last Update Posted : September 2, 2016
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Esketamine 50 mg Drug: Esketamine 20 mg||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Single-dose Mass Balance Study With a Microtracer Dose of 14C-esketamine in Healthy Male Subjects|
|Study Start Date :||March 2016|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
Experimental: Cohort 1
50 milligram (mg) of oral esketamine, fortified with a microtracer dose of 14C-esketamine, as an aqueous solution mixed with apple juice for administration.
Drug: Esketamine 50 mg
50 mg of oral esketamine, fortified with a microtracer dose of 14C-esketamine, as an aqueous solution mixed with apple juice for administration (80 mL total volume)
Experimental: Cohort 2
20 mg of intravenous esketamine in 30 milliliter (mL), fortified with a microtracer dose of 14C-esketamine, as a 30-minute intravenous infusion.
Drug: Esketamine 20 mg
20 mg of intravenous esketamine in 30 mL, fortified with a microtracer dose of 14C-esketamine, as a 30-minute intravenous infusion.
- Characterisation and Identification of 14C-esketamine Metabolites (Metabolic Profile) [ Time Frame: upto 168 hour post-dose ]Collection of urine and feces for 7 days is considered appropriate to characterize the metabolic profile of esketamine. Accelerator mass spectrometry (AMS), an ultrasensitive technique particularly suited for detection of low levels of 14C, will be used to assess levels of the microtracer in whole blood, plasma, and excreta (urine, feces). Plasma, urine and feces selected samples with relatively high radioactive content will be analyzed for metabolic profiling and identification using ultra performance liquid chromatography (UPLC) and AMS.
- Number of Participants With Adverse Events (AEs) or Serious Adverse Events [ Time Frame: up to 41 days ]An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02674295
|United States, Wisconsin|
|Madison, Wisconsin, United States|
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|