Drug-Drug Interaction Study to Evaluate the Effects of Ecopipam on the Pharmacokinetics of Multiple Substrates for Drug Metabolism and Transport
Study Details
Study Description
Brief Summary
This is a single center, open-label, fixed sequence Phase 1, drug-drug interaction (DDI) study in healthy subjects.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
Following a Screening period, eligible subjects will be enrolled sequentially to one of three cohorts to receive a single dose of probe substrate(s), followed by repeated titrated doses of ecopipam twice daily (BID) (with subjects in Cohort 3 also receiving a single dose of ecopipam and probe substrates on Day 4 prior to titration). After steady-state ecopipam dosing is reached, ecopipam will be co-administered with a single dose of probe substrate(s) (with continuation of ecopipam BID (every 12 h) dosing during the blood sampling period for the respective probe substrates), followed by an ecopipam tapering period and clinic discharge assessments.
Study Design
Arms and Interventions
| 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 Substrate 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
ecopipam HCl ~2mg/kg/day
Combination Product: Cohort 1 Probe Substrate 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 Substrate given on 2 separate days: - bupropion: 100mg oral tablet |
Drug: Ecopipam
ecopipam HCl ~2mg/kg/day
Drug: Cohort 2 Probe Substrate
bupropion
|
| Other: Cohort 3 ecopipam HCl oral tablets of 12.5, 50, 75, and 100 mg daily for up to 20 days Cohort 3 Probe Substrate 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
ecopipam HCl ~2mg/kg/day
Combination Product: Cohort 3 Probe Substrate Cocktail
dabigatran, pitavastatin, rosuvastatin, atorvastatin, midazolam
|
Outcome Measures
Primary Outcome Measures
- Cmax of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- Cmax of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- Cmax of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- Cmax oral midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- Cmax of dabigatran in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- Cmax of dabigatran in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- Cmax of pitavastatin (and its pitavastatin lactone metabolite) in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- Cmax of pitavastatin (and its pitavastatin lactone metabolite) in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- Cmax of rosuvastatin in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- Cmax of rosuvastatin in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- Cmax of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- Cmax of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- AUCinf of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- AUCinf of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- AUCinf of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- AUCinf of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- AUCinf of dabigatran in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- AUCinf of dabigatran in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- AUCinf of pitavastatin (and its pitavastatin lactone metabolite) in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- AUCinf of pitavastatin (and its pitavastatin lactone metabolite) in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- AUCinf of rosuvastatin in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- AUCinf of rosuvastatin in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- AUCinf of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- AUCinf of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- AUClast of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- AUClast of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- AUClast of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- AUClast of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- AUClast of dabigatran in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- AUClast of dabigatran in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- AUClast of pitavastatin (and its pitavastatin lactone metabolite) in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- AUClast of pitavastatin (and its pitavastatin lactone metabolite) in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- AUClast of rosuvastatin in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- AUClast of rosuvastatin in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- AUClast of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- AUClast of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- AUC0-24 of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- AUC0-24 of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- AUC0-24 of dabigatran in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- AUC0-24 of dabigatran in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- AUC0-24 of pitavastatin (and its pitavastatin lactone metabolite) in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- AUC0-24 of pitavastatin (and its pitavastatin lactone metabolite) in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- AUC0-24 of rosuvastatin in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- AUC0-24 of rosuvastatin in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- AUC0-24 of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- AUC0-24 of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Secondary Outcome Measures
- Cmax of bupropion (and its 4-hydroxybupropion metabolite) in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- Cmax of bupropion (and its 4-hydroxybupropion metabolite) in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- Cmax omeprazole (and its 5'-hydroxy omeprazole metabolite) in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- Cmax omeprazole (and its 5'-hydroxy omeprazole metabolite) in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- AUCinf of bupropion (and its 4-hydroxybupropion metabolite) in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- AUCinf of bupropion (and its 4-hydroxybupropion metabolite) in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- AUCinf of omeprazole (and its 5'-hydroxy omeprazole metabolite) in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- AUCinf of omeprazole (and its 5'-hydroxy omeprazole metabolite) in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- AUClast of bupropion (and its 4-hydroxybupropion metabolite) in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- AUClast of bupropion (and its 4-hydroxybupropion metabolite) in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- AUClast of omeprazole (and its 5'-hydroxy omeprazole metabolite) in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- AUClast of omeprazole (and its 5'-hydroxy omeprazole metabolite) in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- CL/F for dextromethorphan in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- CL/F for dextromethorphan in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- CL for IV midazolam in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- CL for IV midazolam in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- CL/F for oral midazolam in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- CL/F for oral midazolam in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- CL/F for dabigatran in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- CL/F for dabigatran in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- CL/F for pitavastatin in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- CL/F for pitavastatin in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- CL/F for rosuvastatin in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- CL/F for rosuvastatin in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- CL/F for atorvastatin in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- CL/F for atorvastatin in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- CL/F for bupropion in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- CL/F for bupropion in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- CL/F for caffeine in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- CL/F for caffeine in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- CL/F for omeprazole in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- CL/F for omeprazole in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- V/F for dextromethorphan in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- V/F for dextromethorphan in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- V for IV midazolam in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- V for IV midazolam in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- V/F for oral midazolam in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- V/F for oral midazolam in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- V/F for dabigatran in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- V/F for dabigatran in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- V/F for pitavastatin in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- V/F for pitavastatin in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- V/F for rosuvastatin in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- V/F for rosuvastatin in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- V/F for bupropion in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- V/F for bupropion in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- V/F for atorvastatin in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- V/F for atorvastatin in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- V/F for caffeine in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- V/F for caffeine in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- V/F for omeprazole in the presence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- V/F for omeprazole in the absence of ecopipam [Up to Day 22]
Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- Total concentration of bilirubin in the presence of ecopipam [Up to Day 18]
Bilirubin sampling will occur on Day 1 and Day 18
- Total concentration of bilirubin in the absence of ecopipam [Up to Day 18]
Bilirubin sampling will occur on Day 1 and Day 18
- Unconjugated concentration of bilirubin in the presence of ecopipam [Up to Day 18]
Bilirubin sampling will occur on Day 1 and Day 18
- Unconjugated concentration of bilirubin in the absence of ecopipam [Up to Day 18]
Bilirubin sampling will occur on Day 1 and Day 18
- Conjugated concentration of bilirubin in the presence of ecopipam [Up to Day 18]
Bilirubin sampling will occur on Day 1 and Day 18
- Conjugated concentration of bilirubin in the absence of ecopipam [Up to Day 18]
Bilirubin sampling will occur on Day 1 and Day 18
- Average of the 6-hour plasma dextromethorphan: dextrorphan ratio in the presence of ecopipam [Up to Day 14]
6 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- Average of the 8-hour plasma dextromethorphan: dextrorphan ratio in the presence of ecopipam [Up to Day 14]
6 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- Average of the 12-hour plasma dextromethorphan: dextrorphan ratio in the presence of ecopipam [Up to Day 14]
6 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- Average of the 6-hour plasma dextromethorphan: dextrorphan ratio in the absence of ecopipam [Up to Day 14]
6 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- Average of the 8-hour plasma dextromethorphan: dextrorphan ratio in the absence of ecopipam [Up to Day 14]
6 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- Average of the 12-hour plasma dextromethorphan: dextrorphan ratio in the absence of ecopipam [Up to Day 14]
6 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- Average of the 6-hour plasma caffeine: paraxanthine metabolite ratio in the presence of ecopipam [Up to Day 14]
6 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- Average of the 8-hour plasma caffeine: paraxanthine metabolite ratio in the presence of ecopipam [Up to Day 14]
6 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- Average of the 12-hour plasma caffeine: paraxanthine metabolite ratio in the presence of ecopipam [Up to Day 14]
6 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- Average of the 6-hour plasma caffeine: paraxanthine metabolite ratio in the absence of ecopipam [Up to Day 14]
6 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- Average of the 8-hour plasma caffeine: paraxanthine metabolite ratio in the absence of ecopipam [Up to Day 14]
6 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- Average of the 12-hour plasma caffeine: paraxanthine metabolite ratio in the absence of ecopipam [Up to Day 14]
6 blood samples will be collected at the indicated time points for pharmacokinetic analysis
- Safety and tolerability as demonstrated by the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) [Up to Day 63]
Score from 0-5 where 0 is no response and 5 is responds readily. MOAA/S measures will be recorded at the indicated timepoints
- Safety and tolerability as demonstrated by the Columbia Suicide Severity Rating Scale (C-SSRS) [Up to Day 63]
Safety and tolerability measures will be recorded at the indicated timepoints
- Number of participants requiring concomitant medications [Up to Day 63]
Participants will be continuously monitored for the use of concomitant medications
- AEs with relatedness associated with dextromethorphan [Up to Day 63]
Subjects will be continually monitored for adverse events
- AEs with relatedness associated with IV midazolam [Up to Day 63]
Subjects will be continually monitored for adverse events
- AEs with relatedness associated with oral midazolam [Up to Day 63]
Subjects will be continually monitored for adverse events
- AEs with relatedness associated with dabigatran [Up to Day 63]
Subjects will be continually monitored for adverse events
- AEs with relatedness associated with pitavastatin [Up to Day 63]
Subjects will be continually monitored for adverse events
- AEs with relatedness associated with rosuvastatin [Up to Day 63]
Subjects will be continually monitored for adverse events
- AEs with relatedness associated with atorvastatin [Up to Day 63]
Subjects will be continually monitored for adverse events
- AEs with relatedness associated with bupropion [Up to Day 63]
Subjects will be continually monitored for adverse events
- AEs with relatedness associated with caffeine [Up to Day 63]
Subjects will be continually monitored for adverse events
- AEs with relatedness associated with omeprazole [Up to Day 63]
Subjects will be continually monitored for adverse events
- AEs with relatedness associated with ecopipam [Up to Day 63]
Subjects will be continually monitored for adverse events
- Absolute values of white blood cell (WBC), neutrophils, lymphocytes, monocytes, eosinophils, basophils and platelets (1000/mm3) [Up to Day 26]
Blood samples will be collected for the assessment of hematology parameters
- Absolute values of hematocrit (percent) [Up to Day 26]
Blood samples will be collected for the assessment of hematology parameters
- Absolute values of hemoglobin (g/dL) [Up to Day 26]
Blood samples will be collected for the assessment of hematology parameters
- Absolute values of Red blood cell (RBC) count (M/mm3) [Up to Day 26]
Blood samples will be collected for the assessment of hematology parameters
- Absolute values of sodium, potassium, chloride (mmol/L) [Up to Day 26]
Blood samples will be collected for the assessment of clinical chemistry parameters
- Absolute values of magnesium, urea, phosphorus, calcium, glucose, and total, conjugated and unconjugated bilirubin (mg/dL) [Up to Day 26]
Blood samples will be collected for the assessment of clinical chemistry parameters
- Absolute values of albumin and total protein (g/dL) [Up to Day 26]
Blood samples will be collected for the assessment of clinical chemistry parameters
- Absolute values of alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma glutamyl transferase (GGT), creatinine phosphokinase (CPK), and creatinine (U/L) [Up to Day 26]
Blood samples will be collected for the assessment of clinical chemistry parameters
- Absolute values of urine specific gravity [Up to Day 26]
Urine samples will be collected for the assessment of urine parameters
- Absolute values of urine pH [Up to Day 26]
Urine samples will be collected for the assessment of urine parameters
- Absolute values of urine glucose [Up to Day 26]
Urine samples will be collected for the assessment of urine parameters
- Absolute values of urine protein [Up to Day 26]
Urine samples will be collected for the assessment of urine parameters
- Absolute values of urine blood [Up to Day 26]
Urine samples will be collected for the assessment of urine parameters
- Absolute values of urine ketones [Up to Day 26]
Urine samples will be collected for the assessment of urine parameters
- Absolute values of urine bilirubin and nitrite [Up to Day 26]
Urine samples will be collected for the assessment of urine parameters
- Absolute values of urobilinogen (Eu/dL) [Up to Day 26]
Urine samples will be collected for the assessment of urine parameters
- Absolute values of urine leukocytes by dipstick [Up to Day 26]
Urine samples will be collected for the assessment of urine parameters
- Change from Day -1 to Day of Discharge white blood cell (WBC), neutrophils, lymphocytes, monocytes, eosinophils, basophils and platelets (1000/mm3) [Up to Day 26]
Blood samples will be collected for the assessment of hematology parameters
- Change from Day -1 to Day of Discharge in hematocrit (percent) [Up to Day 26]
Blood samples will be collected for the assessment of hematology parameters
- Change from Day -1 to Day of Discharge in hemoglobin (g/dL) [Up to Day 26]
Blood samples will be collected for the assessment of hematology parameters
- Change from Day -1 to Day of Discharge in Red blood cell (RBC) count (M/mm3) [Up to Day 26]
Blood samples will be collected for the assessment of hematology parameters
- Change from Day -1 to Day of Discharge in sodium, potassium, chloride (mmol/L) [Up to Day 26]
Blood samples will be collected for the assessment of clinical chemistry parameters
- Change from Day -1 to Day of Discharge in magnesium, urea, phosphorus, calcium, glucose, and total, conjugated and unconjugated bilirubin (mg/dL) [Up to Day 26]
Blood samples will be collected for the assessment of clinical chemistry parameters
- Change from Day -1 to Day of Discharge in albumin and total protein (g/dL) [Up to Day 26]
Blood samples will be collected for the assessment of clinical chemistry parameters
- 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), and creatinine (U/L) [Up to Day 26]
Blood samples will be collected for the assessment of clinical chemistry parameters
- Change from Day -1 to Day of Discharge in urine specific gravity [Up to Day 26]
Urine samples will be collected for the assessment of urine parameters
- Change from Day -1 to Day of Discharge in urine pH [Up to Day 26]
Urine samples will be collected for the assessment of urine parameters
- Change from Day -1 to Day of Discharge in urine glucose [Up to Day 26]
Urine samples will be collected for the assessment of urine parameters
- Change from Day -1 to Day of Discharge in urine protein [Up to Day 26]
Urine samples will be collected for the assessment of urine parameters
- Change from Day -1 to Day of Discharge in urine blood [Up to Day 26]
Urine samples will be collected for the assessment of urine parameters
- Change from Day -1 to Day of Discharge in urine ketones [Up to Day 26]
Urine samples will be collected for the assessment of urine parameters
- Change from Day -1 to Day of Discharge in urine bilirubin and nitrite [Up to Day 26]
Urine samples will be collected for the assessment of urine parameters
- Change from Day -1 to Day of Discharge in urobilinogen (Eu/dL) [Up to Day 26]
Urine samples will be collected for the assessment of urine parameters
- Change from Day -1 to Day of Discharge in urine leukocytes by dipstick [Up to Day 26]
Urine samples will be collected for the assessment of urine parameters
- Absolute values of electrocardiogram (ECG) parameters: PR, QRS, QT, and QT interval corrected for heart rate using Fridericia's formula (QTcF) (Milliseconds) [Up to Day 26]
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
- Change from pre-dose for the respective day in ECG parameters: PR, QRS, QT, and QTcF (Milliseconds) [Up to Day 26]
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
- Absolute values of oral temperature (degrees Celsius) [Up to Day 26]
Temperature will be assessed as part of vital signs
- Change from pre-dose for the respective day in oral temperature (degrees Celsius) [Up to Day 26]
Temperature will be assessed as part of vital signs
- Absolute values of heart rate (beats/minute) [Up to Day 26]
Heart rate will be assessed as part of vital signs
- Change from pre-dose for the respective day in heart rate (beats/minute) [Up to Day 26]
Heart rate will be assessed as part of vital signs
- Absolute values of respiratory rate (breaths/minute) [Up to Day 26]
Respiratory rate will be assessed as part of vital signs
- Absolute values of systolic blood pressure (SBP) and diastolic blood pressure (DBP) (mmHG) [Up to Day 26]
Blood pressure will be assessed as part of vital signs
- Change from pre-dose for the respective day in SBP and DBP (mmHG) [Up to Day 26]
Blood pressure will be assessed as part of vital signs
- Absolute values of mean corpuscular hemoglobin (MCH) (pg) [Up to Day 26]
Blood samples will be collected for the assessment of hematology parameters
- Change from Day 1 to Day of Discharge of mean corpuscular hemoglobin (MCH) (pg) [Up to Day 26]
Blood samples will be collected for the assessment of hematology parameters
- Absolute values of mean corpuscular volume (MCV) (fL) [Up to Day 26]
Blood samples will be collected for the assessment of hematology parameters
- Change from Day 1 to Day of Discharge of mean corpuscular volume (MCV) (fL) [Up to Day 26]
Blood samples will be collected for the assessment of hematology parameters
- Absolute values of mean corpuscular hemoglobin concentration (MCHC) (g/dL) [Up to Day 26]
Blood samples will be collected for the assessment of hematology parameters
- Change from Day 1 to Day of Discharge of mean corpuscular hemoglobin concentration (MCHC) (g/dL) [Up to Day 26]
Blood samples will be collected for the assessment of hematology parameters
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male subjects or female subjects of non-childbearing potential
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≥18 and <55 years of age at the time of consent
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BMI >18.5 and <30 kg/m2 and a weight of ≥50 kg for males or ≥45 kg for females
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Subjects must be healthy, as determined by the Investigator, based on medical history, physical examination, ECG, and standard panel of blood and laboratory tests at Screening.
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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
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Male subjects must be willing not to donate sperm until 90 days following the last study drug administration
Exclusion Criteria:
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Personal or family History of significant medical illness
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Clinically significant abnormalities on screening tests/exams
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History of or significant risk of committing suicide
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Donation of plasma within 7 days prior to dosing
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Donation or significant loss of blood within 30 days prior to the first dosing
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Major surgery within 3 months or minor surgery within 1 month prior to admission
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Use of prohibited prescription, over-the-counter medications or natural health products
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Alcohol-based products 24 hours prior to admission
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Female subjects who are currently pregnant or lactating
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Positive pregnancy test
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Use of tobacco or nicotine products within 3 months prior to Screening
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Significant alcohol consumption
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History of drug abuse within the previous 2 years, or a positive drug screen
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History of allergy to study medications
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Undergoing abrupt discontinuation of alcohol or sedatives
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Not suitable for study in the opinion of the Principal Investigator
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | ICON Early Phase Services | San Antonio | Texas | United States | 78209 |
Sponsors and Collaborators
- Emalex Biosciences Inc.
- ICON Early Phase Services
- Nuventra
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EBS-101-HV-104