Drug-Drug Interaction Study to Evaluate the Effects of Ecopipam on the Pharmacokinetics of Multiple Substrates

A Phase 1, Open-Label, Fixed Sequence Drug-Drug Interaction Study to Evaluate the Effects of Repeat Doses of Ecopipam on the Pharmacokinetics of Multiple Substrates for Drug Metabolism and Transport in Healthy Subjects

This is a single center, open-label, fixed sequence Phase 1, drug-drug interaction (DDI) study in healthy subjects.

Study Overview

• Status: Terminated
• Conditions: Drug-Interactions
• Intervention / Treatment: Drug: ecopipam HCl ~2mg/kg/day; Combination product: Cohort 1 Probe Cocktail; Combination product: Cohort 2 Probe Cocktail; Combination product: Cohort 3 Probe Cocktail

Detailed Description

Following a screening period of up to 28 days, subjects will be admitted to the clinical research unit into one of three cohorts. On the morning of Day 1, subjects in cohorts 1, 2, and 3 will receive fasted doses of probe substrate(s) per assigned cohort. On Day 5, Cohort 2 only will receive a second fasted dose of probe substrates. Subjects in cohorts 1, 2, and 3 will receive the final fasted dose of probe substrate(s) on Day 13. Fasted ecopipam administration will begin on Day 5 and will continue through Day 17 at ~2mg/kg for all cohorts. Ecopipam doses will be tapered starting on Day 18 by 25 mg/day increments until subjects are off drug, with final discharge occurring 24 hours after the ecopipam HCl dose has been reduced to 25 mg (Day 21, 23, or 25).

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Syneos Health Clinical Research Services, LLC.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male subjects or female subjects of non-childbearing potential
• ≥18 and <55 years of age at the time of consent
• BMI >18.5 and <30 kg/m2 and a weight of ≥50 kg for males or ≥45 kg for females
• Sexually active males must use a double barrier method of contraception during the study and for at least 90 days after the last dose of study drug
• Male subjects must be willing not to donate sperm until 90 days following the last study drug administration

Exclusion Criteria:

• Personal or family History of significant medical illness
• Clinically significant abnormalities on screening tests/exams
• History of or significant risk of committing suicide
• Donation of plasma within 7 days prior to dosing
• Donation or significant loss of blood within 30 days prior to the first dosing
• Major surgery within 3 months or minor surgery within 1 month prior to admission
• Use of prohibited prescription, over-the-counter medications or natural health products
• Alcohol-based products 24 hours prior to admission
• Female subjects who are currently pregnant or lactating
• Positive pregnancy test
• Use of tobacco or nicotine products within 3 months prior to Screening
• Significant alcohol consumption
• History of drug abuse within the previous 2 years, or a positive drug screen
• History of allergy to study medications
• Undergoing abrupt discontinuation of alcohol or sedatives
• Not suitable for study in the opinion of the Principal Investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Cohort 1; ecopipam HCl oral tablets of 12.5, 50, 75, and 100 mg daily for up to 20 days Cohort 1 Probe Cocktail given on 2 separate days: midazolam: 1 µg infused IV; caffeine: 200 mg oral tablet; omeprazole: two 20 mg oral tablets; dextromethorphan: 1.6mL (containing ~10 mg) oral solution	Drug: ecopipam HCl ~2mg/kg/day; oral tablet; Combination product: Cohort 1 Probe Cocktail; dextromethorphan, caffeine, omeprazole, and midazolam
OTHER: Cohort 2; ecopipam HCl oral tablets of 12.5, 50, 75, and 100 mg daily for up to 20 days Cohort 2 Probe Cocktail given on 3 separate days: midazolam: 10 µg/mL given as 1mL oral solution.; dabigatran: 375 µg/mL and pitavastatin: 10 µg/mL given as 1mL oral solution; rosuvastatin: 25 µg/mL and atorvastatin: 50 µg/mL given as 2mL oral solution	Drug: ecopipam HCl ~2mg/kg/day; oral tablet; Combination product: Cohort 2 Probe Cocktail; dabigatran, pitavastatin, rosuvastatin, atorvastatin, midazolam
OTHER: Cohort 3; ecopipam HCl oral tablets of 12.5, 50, 75, and 100 mg daily for up to 20 days Cohort 3 Probe Cocktail given on 2 separate days: - bupropion: 100mg oral tablet	Drug: ecopipam HCl ~2mg/kg/day; oral tablet; Combination product: Cohort 3 Probe Cocktail; bupropion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax of dextromethorphan (and its dextrorphan metabolite) in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
Cmax of dextromethorphan (and its dextrorphan metabolite) in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
Cmax of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
Cmax of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
Cmax of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
Cmax oral midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
Cmax of dabigatran in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
Cmax of dabigatran in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
Cmax of pitavastatin (and its pitavastatin lactone metabolite) in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
Cmax of pitavastatin (and its pitavastatin lactone metabolite) in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
Cmax of rosuvastatin in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
Cmax of rosuvastatin in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
Cmax of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
Cmax of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
AUCinf of dextromethorphan (and its dextrorphan metabolite) in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
AUCinf of dextromethorphan (and its dextrorphan metabolite) in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
AUCinf of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
AUCinf of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
AUCinf of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
AUCinf of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
AUCinf of dabigatran in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
AUCinf of dabigatran in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
AUCinf of pitavastatin (and its pitavastatin lactone metabolite) in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
AUCinf of pitavastatin (and its pitavastatin lactone metabolite) in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic	Up to Day 18
AUCinf of rosuvastatin in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic	Up to Day 18
AUCinf of rosuvastatin in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic	Up to Day 18
AUCinf of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic	Up to Day 18
AUCinf of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic	Up to Day 18
AUClast of dextromethorphan (and its dextrorphan metabolite) in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic	Up to Day 18
AUClast of dextromethorphan (and its dextrorphan metabolite) in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic	Up to Day 18
AUClast of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic	Up to Day 18
AUClast of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic	Up to Day 18
AUClast of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic	Up to Day 18
AUClast of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic	Up to Day 18
AUClast of dabigatran in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic	Up to Day 18
AUClast of dabigatran in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic	Up to Day 18
AUClast of pitavastatin (and its pitavastatin lactone metabolite) in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic	Up to Day 18
AUClast of pitavastatin (and its pitavastatin lactone metabolite) in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic	Up to Day 18
AUClast of rosuvastatin in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic	Up to Day 18
AUClast of rosuvastatin in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic	Up to Day 18
AUClast of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic	Up to Day 18
AUClast of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic	Up to Day 18

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax of bupropion (and its 4-hydroxybupropion metabolite) in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
Cmax of bupropion (and its 4-hydroxybupropion metabolite) in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
Cmax of caffeine (and its metabolite paraxanthine) in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
Cmax of caffeine (and its metabolite paraxanthine) in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
Cmax omeprazole (and its 5'-hydroxy omeprazole metabolite) in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
Cmax omeprazole (and its 5'-hydroxy omeprazole metabolite) in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
AUCinf of bupropion (and its 4-hydroxybupropion metabolite) in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
AUCinf of bupropion (and its 4-hydroxybupropion metabolite) in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
AUCinf of caffeine (and its metabolite paraxanthine) in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
AUCinf of caffeine (and its metabolite paraxanthine) in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
AUCinf of omeprazole (and its 5'-hydroxy omeprazole metabolite) in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
AUCinf of omeprazole (and its 5'-hydroxy omeprazole metabolite) in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
AUClast of bupropion (and its 4-hydroxybupropion metabolite) in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
AUClast of bupropion (and its 4-hydroxybupropion metabolite) in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
AUClast of caffeine (and its metabolite paraxanthine) in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
AUClast of caffeine (and its metabolite paraxanthine) in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
AUClast of omeprazole (and its 5'-hydroxy omeprazole metabolite) in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
AUClast of omeprazole (and its 5'-hydroxy omeprazole metabolite) in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
CL/F for dextromethorphan in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
CL/F for dextromethorphan in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
CL/F for IV midazolam in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
CL/F for IV midazolam in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
CL/F for oral midazolam in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
CL/F for oral midazolam in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
CL/F for dabigatran in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
CL/F for dabigatran in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
CL/F for pitavastatin in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
CL/F for pitavastatin in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
CL/F for rosuvastatin in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
CL/F for rosuvastatin in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
CL/F for atorvastatin in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
CL/F for atorvastatin in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
CL/F for bupropion in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
CL/F for bupropion in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
CL/F for caffeine in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
CL/F for caffeine in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
CL/F for omeprazole in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
CL/F for omeprazole in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
V/F for dextromethorphan in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
V/F for dextromethorphan in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
V/F for IV midazolam in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
V/F for IV midazolam in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
V/F for oral midazolam in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
V/F for oral midazolam in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
V/F for dabigatran in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
V/F for dabigatran in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
V/F for pitavastatin in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
V/F for pitavastatin in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
V/F for rosuvastatin in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
V/F for rosuvastatin in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
V/F for atorvastatin in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
V/F for atorvastatin in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
V/F for bupropion in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
V/F for bupropion in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
V/F for caffeine in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
V/F for caffeine in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
V/F for omeprazole in the presence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
V/F for omeprazole in the absence of ecopipam	Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis	Up to Day 18
Total concentration of bilirubin in the presence of ecopipam	Bilirubin sampling will occur on Day 1 and Day 13	Up to Day 13
Total concentration of bilirubin in the absence of ecopipam	Bilirubin sampling will occur on Day 1 and Day 13	Up to Day 13
Unconjugated concentration of bilirubin in the presence of ecopipam	Bilirubin sampling will occur on Day 1 and Day 13	Up to Day 13
Unconjugated concentration of bilirubin in the absence of ecopipam	Bilirubin sampling will occur on Day 1 and Day 13	Up to Day 13
Safety and tolerability as demonstrated by MOAA/S	Safety and tolerability measures will be recorded at the indicated timepoints.	Up to Day 55
Safety and tolerability as demonstrated by C-SSRS	Safety and tolerability measures will be recorded at the indicated timepoints.	Up to Day 55
Safety and tolerability as demonstrated by concomitant medications	Safety and tolerability measures will be recorded at the indicated timepoints.	Up to Day 55
AEs with relatedness associated with dextromethorphan	Subjects will be continually monitored for adverse events	Up to Day 55
AEs with relatedness associated with IV midazolam	Subjects will be continually monitored for adverse events	Up to Day 55
AEs with relatedness associated with oral midazolam	Subjects will be continually monitored for adverse events	Up to Day 55
AEs with relatedness associated with dabigatran	Subjects will be continually monitored for adverse events	Up to Day 55
AEs with relatedness associated with pitavastatin	Subjects will be continually monitored for adverse events	Up to Day 55
AEs with relatedness associated with rosuvastatin	Subjects will be continually monitored for adverse events	Up to Day 55
AEs with relatedness associated with atorvastatin	Subjects will be continually monitored for adverse events	Up to Day 55
AEs with relatedness associated with bupropion	Subjects will be continually monitored for adverse events	Up to Day 55
AEs with relatedness associated with caffeine	Subjects will be continually monitored for adverse events	Up to Day 55
AEs with relatedness associated with omeprazole	Subjects will be continually monitored for adverse events	Up to Day 55
AEs with relatedness associated with ecopipam	Subjects will be continually monitored for adverse events	Up to Day 55
Absolute values of white blood cell (WBC) count (K/Ul)	Blood samples will be collected for the assessment of hematology parameters.	Up to Day 25
Absolute values of neutrophils, lymphocytes, monocytes, eosinophils, and basophils (10E3/uL)	Up to Day 25	Blood samples will be collected for the assessment of hematology parameters.
Absolute values of platelets (K/uL)	Blood samples will be collected for the assessment of hematology parameters.	Up to Day 25
Absolute values of hematocrit (%)	Blood samples will be collected for the assessment of hematology parameters.	Up to Day 25
Absolute values of hemoglobin (g/dL)	Blood samples will be collected for the assessment of hematology parameters.	Up to Day 25
Absolute values of Red blood cell (RBC) count (M/uL)	Blood samples will be collected for the assessment of hematology parameters.	Up to Day 25
Absolute values of blood sodium, magnesium, urea, phosphorus, potassium, and chloride (mg/dL)	Blood samples will be collected for the assessment of clinical chemistry parameters.	Up to Day 25
Absolute values of creatinine, calcium, glucose, and direct and total bilirubin (mg/dL)	Blood samples will be collected for the assessment of clinical chemistry parameters.	Up to Day 25
Absolute values of albumin and total protein (g/dL)	Blood samples will be collected for the assessment of clinical chemistry parameters.	Up to Day 25
Absolute values of alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma glutamyl transferase (GGT), and creatinine phosphokinase (CPK) (U/L)	Blood samples will be collected for the assessment of clinical chemistry parameters.	Up to Day 25
Absolute values of urine specific gravity	Urine samples will be collected for the assessment of urine parameters.	Up to Day 25
Absolute values of urine pH	Urine samples will be collected for the assessment of urine parameters.	Up to Day 25
Absolute values of urine glucose	Urine samples will be collected for the assessment of urine parameters.	Up to Day 25
Absolute values of urine protein	Urine samples will be collected for the assessment of urine parameters.	Up to Day 25
Absolute values of urine blood	Urine samples will be collected for the assessment of urine parameters.	Up to Day 25
Absolute values of urine ketones	Urine samples will be collected for the assessment of urine parameters.	Up to Day 25
Absolute values of urine bilirubin, urobilinogen, and nitrite	Urine samples will be collected for the assessment of urine parameters.	Up to Day 25
Absolute values of urine leukocytes by dipstick	Urine samples will be collected for the assessment of urine parameters.	Up to Day 25
Change from Day -1 to Day of Discharge in white blood cell (WBC) count (K/Ul)	Blood samples will be collected for the assessment of hematology parameters.	Up to Day 25
Change from Day -1 to Day of Discharge in neutrophils, lymphocytes, monocytes, eosinophils, and basophils (10E3/uL)	Blood samples will be collected for the assessment of hematology parameters.	Up to Day 25
Change from Day -1 to Day of Discharge in platelets (K/uL)	Blood samples will be collected for the assessment of hematology parameters.	Up to Day 25
Change from Day -1 to Day of Discharge in hematocrit (%)	Blood samples will be collected for the assessment of hematology parameters.	Up to Day 25
Change from Day -1 to Day of Discharge in hemoglobin (g/dL)	Blood samples will be collected for the assessment of hematology parameters.	Up to Day 25
Change from Day -1 to Day of Discharge in Red blood cell (RBC) count (M/uL)	Blood samples will be collected for the assessment of hematology parameters.	Up to Day 25
Change from Day -1 to Day of Discharge in blood sodium, magnesium, urea, phosphorus, potassium, and chloride (mg/dL)	Blood samples will be collected for the assessment of clinical chemistry parameters.	Up to Day 25
Change from Day -1 to Day of Discharge in creatinine, calcium, glucose, and direct and total bilirubin (mg/dL)	Blood samples will be collected for the assessment of clinical chemistry parameters.	Up to Day 25
Change from Day -1 to Day of Discharge in albumin and total protein (g/dL)	Blood samples will be collected for the assessment of clinical chemistry parameters.	Up to Day 25
Change from Day -1 to Day of Discharge in alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma glutamyl transferase (GGT), and creatinine phosphokinase (CPK) (U/L)	Blood samples will be collected for the assessment of clinical chemistry parameters.	Up to Day 25
Change from Day -1 to Day of Discharge in urine specific gravity	Urine samples will be collected for the assessment of urine parameters.	Up to Day 25
Change from Day -1 to Day of Discharge in urine pH	Urine samples will be collected for the assessment of urine parameters.	Up to Day 25
Change from Day -1 to Day of Discharge in urine glucose	Urine samples will be collected for the assessment of urine parameters.	Up to Day 25
Change from Day -1 to Day of Discharge in urine protein	Urine samples will be collected for the assessment of urine parameters.	Up to Day 25
Change from Day -1 to Day of Discharge in urine blood	Urine samples will be collected for the assessment of urine parameters.	Up to Day 25
Change from Day -1 to Day of Discharge in urine ketones	Urine samples will be collected for the assessment of urine parameters.	Up to Day 25
Change from Day -1 to Day of Discharge in urine bilirubin, urobilinogen, and nitrite (Milligrams per deciliter)	Urine samples will be collected for the assessment of urine parameters.	Up to Day 25
Change from Day -1 to Day of Discharge in urine leukocytes by dipstick	Urine samples will be collected for the assessment of urine parameters.	Up to Day 25
Absolute values of electrocardiogram (ECG) parameters: PR, QRS, QT, and QT interval corrected for heart rate using Fridericia's formula (QTcF) (Milliseconds)	Twelve-lead ECGs will be obtained with the participant in a supine position after a rest of at least 5 minutes using an automated ECG machine. PR, QRS, QT, and QTcF intervals will be measured.	Up to Day 25
Change from pre-dose for the respective day in ECG parameters: PR, QRS, QT, and QTcF (Milliseconds)	Twelve-lead ECGs will be obtained with the participant in a supine position after a rest of at least 5 minutes using an automated ECG machine. PR, QRS, QT, and QTcF intervals will be measured.	Up to Day 25
Absolute values of oral temperature (degrees Celsius)	Temperature will be assessed as part of vital signs.	Up to Day 25
Change from pre-dose for the respective day in oral temperature (degrees Celsius)	Temperature will be assessed as part of vital signs.	Up to Day 25
Absolute values of heart rate (beats/minute)	Heart rate will be assessed as part of vital signs.	Up to Day 25
Change from pre-dose for the respective day in heart rate (beats/minute)	Heart rate will be assessed as part of vital signs.	Up to Day 25
Absolute values of respiratory rate (breaths/minute)	Respiratory rate will be assessed as part of vital signs.	Up to Day 25
Change from pre-dose for the respective day in respiratory rate (breaths/minute)	Respiratory rate will be assessed as part of vital signs.	Up to Day 25
Absolute values of systolic blood pressure (SBP) and diastolic blood pressure (DBP) (mmHG)	Blood pressure will be assessed as part of vital signs.	Up to Day 25
Change from pre-dose for the respective day in SBP and DBP (mmHG)	Blood pressure will be assessed as part of vital signs.	Up to Day 25

Collaborators and Investigators

• Sponsor: Emalex Biosciences Inc.
• Collaborators: Syneos Health; Nuventra

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 18, 2021
• Primary Completion (ACTUAL): April 2, 2021
• Study Completion (ACTUAL): May 7, 2021

Study Registration Dates

• First Submitted: January 18, 2021
• First Submitted That Met QC Criteria: February 18, 2021
• First Posted (ACTUAL): February 21, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 24, 2021
• Last Update Submitted That Met QC Criteria: May 20, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Dopamine Agents; Dopamine Antagonists; Ecopipam
• Other Study ID Numbers: EBS-101-HV-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No