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| Name | Class |
|---|---|
| Syneos Health | OTHER |
| Cambridge Cognition Ltd | INDUSTRY |
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This is a single center, 2-Part, Phase 1, open-label, fixed-sequence, drug-drug interaction study designed to compare the PK of ecopipam when administered alone and in combination with itraconazole (Part 1) or rifampicin (Part 2) in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental | ecopipam 89.6 mg on Days 1 and 9 with repeat doses of itraconazole Days 6-16. |
|
| Part 2 | Experimental | ecopipam 179.2 mg on Days 1 and 13 with repeat doses of rifampicin days 6-20. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Itraconazole | Drug | itraconazole 200 mg QD Days 6 to 16 |
| |
| rifampicin |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-inf of ecopipam when administered with itraconazole | Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 21 |
| AUC0-inf of ecopipam when administered without itraconazole | Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 21 |
| AUC0-inf of ecopipam when administered with rifampicin | Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 21 |
| AUC0-inf of ecopipam when administered without rifampicin | Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 21 |
| AUC0-t of ecopipam when administered with itraconazole | Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 21 |
| AUC0-t of ecopipam when administered without itraconazole | Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 21 |
| AUC0-t of ecopipam when administered with rifampicin | Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-inf of EBS-101-40853 | Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 21 |
| AUC0-inf of ecopipam glucuronide | Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rick Munschauer, MSc, MD, FAAN | Emalex Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Syneos Health Clinic Inc. | Québec | Quebec | G1P 0A2 | Canada |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| D012293 | Rifampin |
| C058081 | ecopipam |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
rifampicin 600 mg QD Days 6 to 20 |
|
| Ecopipam | Drug | 89.6 mg on Days 1 and 9 for Part 1 or 179.2 mg on Days 1 and 13 for Part 2 |
|
| AUC0-t of ecopipam when administered without rifampicin | Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 21 |
| Cmax of ecopipam when administered with itraconazole | Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 21 |
| Cmax of ecopipam when administered without itraconazole | Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 21 |
| Cmax of ecopipam when administered with rifampicin | Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 21 |
| Cmax of ecopipam when administered without rifampicin | Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 21 |
| T½ el of ecopipam when administered with itraconazole | Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 21 |
| T½ el of ecopipam when administered without itraconazole | Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 21 |
| T½ el of ecopipam when administered with rifampicin | Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 21 |
| T½ el of ecopipam when administered without rifampicin | Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 21 |
| Up to Day 21 |
| AUC0-inf of EBS-101-40853 glucuronide | Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 21 |
| AUC0-t of EBS-101-40853 | Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 21 |
| AUC0-t of ecopipam glucuronide | Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 21 |
| AUC0-t of EBS-101-40853 glucuronide | Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 21 |
| Cmax of EBS-101-40853 | Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 21 |
| Cmax of ecopipam glucuronide | Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 21 |
| Cmax of EBS-101-40853 glucuronide | Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 21 |
| T½ el of EBS-101-40853 | Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 21 |
| T½ el of ecopipam glucuronide | Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 21 |
| T½ el of EBS-101-40853 glucuronide | Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 21 |
| AUC0-4 for ecopipam | Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 21 |
| AUC0-4 for EBS-101-40853 | Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 21 |
| AUC0-4 for ecopipam glucuronide | Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 21 |
| AUC0-4 for EBS 101-40853 glucuronide | Up to 38 samples will be collected at the indicated time points for pharmacokinetic analysis | Up to Day 21 |
| Minimum Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score | Score from 0-5 where 0 is no response and 5 is responds readily. MOAA/S measures will be recorded at the indicated timepoints | Up to Day 21 |
| AUEC for Visual Analogue Scale (VAS) | Score from 0 - 100 where 0 is not sedated and 100 is very sedated. VAS measures will be recorded at the indicated timepoints. | Up to Day 21 |
| Maximum sedation for Visual Analogue Scale (VAS) | Score from 0 - 100 where 0 is not sedated and 100 is very sedated. VAS measures will be recorded at the indicated timepoints. | Up to Day 21 |
| AUEC for Reaction Time Index (RTI) score | Reaction time for subject to release the response button after presentation of target stimulus. | Up to Day 21 |
| Maximum sedation for Reaction Time Index (RTI) score | Reaction time for subject to release the response button after presentation of target stimulus. | Up to Day 21 |
| Safety and tolerability as demonstrated by AEs with itraconazole | Subjects will be continually monitored for adverse events | Up to Day 30 |
| Safety and tolerability as demonstrated by AEs without itraconazole | Subjects will be continually monitored for adverse events | Up to Day 30 |
| Safety and tolerability as demonstrated by AEs with rifampicin | Subjects will be continually monitored for adverse events | Up to Day 30 |
| Safety and tolerability as demonstrated by AEs without rifampicin | Subjects will be continually monitored for adverse events | Up to Day 30 |
| Safety and tolerability as demonstrated by Systolic blood pressure (SBP) and diastolic blood pressure (DBP) with itraconazole (mmHG) | Blood pressure will be assessed as part of vital signs | Up to Day 21 |
| Safety and tolerability as demonstrated by Systolic blood pressure (SBP) and diastolic blood pressure (DBP) without itraconazole(mmHG) | Blood pressure will be assessed as part of vital signs | Up to Day 21 |
| Safety and tolerability as demonstrated by Systolic blood pressure (SBP) and diastolic blood pressure (DBP) with rifampicin(mmHG) | Blood pressure will be assessed as part of vital signs | Up to Day 21 |
| Safety and tolerability as demonstrated by Systolic blood pressure (SBP) and diastolic blood pressure (DBP) without rifampicin(mmHG) | Blood pressure will be assessed as part of vital signs | Up to Day 21 |
| Heart rate with itraconazole (beats/minute) | Heart rate will be assessed as part of vital signs | Up to Day 21 |
| Heart rate without itraconazole (beats/minute) | Heart rate will be assessed as part of vital signs | Up to Day 21 |
| Heart rate with rifampicin (beats/minute) | Heart rate will be assessed as part of vital signs | Up to Day 21 |
| Heart rate without rifampicin (beats/minute) | Heart rate will be assessed as part of vital signs | Up to Day 21 |
| Respiratory rate pressure with itraconazole (breaths/minute) | Respiratory rate will be assessed as part of vital signs | Up to Day 21 |
| Respiratory rate without itraconazole (breaths/minute) | Respiratory rate will be assessed as part of vital signs | Up to Day 21 |
| Respiratory rate with rifampicin (breaths/minute) | Respiratory rate will be assessed as part of vital signs | Up to Day 21 |
| Respiratory rate without rifampicin (breaths/minute) | Respiratory rate will be assessed as part of vital signs | Up to Day 21 |
| Oral temperature with itraconazole (degrees Celsius) | Temperature will be assessed as part of vital signs | Up to Day 21 |
| Oral temperature without itraconazole (degrees Celsius) | Temperature will be assessed as part of vital signs | Up to Day 21 |
| Oral temperature with rifampicin (degrees Celsius) | Temperature will be assessed as part of vital signs | Up to Day 21 |
| Oral temperature without rifampicin (degrees Celsius) | Temperature will be assessed as part of vital signs | Up to Day 21 |
| Electrocardiogram (ECG) parameters: PR, RR, QRS, QT, and QT interval corrected for heart rate using Fridericia's formula (QTcF) with itraconazole (Milliseconds) | Twelve-lead ECGs will be obtained at the indicated timepoints | Up to Day 21 |
| Electrocardiogram (ECG) parameters: PR, RR, QRS, QT, and QT interval corrected for heart rate using Fridericia's formula (QTcF) without itraconazole (Milliseconds) | Twelve-lead ECGs will be obtained at the indicated timepoints | Up to Day 21 |
| Electrocardiogram (ECG) parameters: PR, RR, QRS, QT, and QT interval corrected for heart rate using Fridericia's formula (QTcF) with rifampicin (Milliseconds) | Twelve-lead ECGs will be obtained at the indicated timepoints | Up to Day 21 |
| Electrocardiogram (ECG) parameters: PR, RR, QRS, QT, and QT interval corrected for heart rate using Fridericia's formula (QTcF) without rifampicin (Milliseconds) | Twelve-lead ECGs will be obtained at the indicated timepoints | Up to Day 21 |
| Safety and tolerability as demonstrated by the Columbia Suicide Severity Rating Scale (C-SSRS) | C-SSRS to be administered at the indicated timepoints | Up to Day 21 |
| Values of white blood cell (WBC), neutrophils, lymphocytes, monocytes, eosinophils, basophils and platelets (1000/mm3) | Blood samples will be collected for the assessment of hematology parameters | Up to Day 21 |
| Value of hematocrit (percent) | Blood samples will be collected for the assessment of hematology parameters | Up to Day 21 |
| Value of hemoglobin (g/dL) | Blood samples will be collected for the assessment of hematology parameters | Up to Day 21 |
| Red blood cell (RBC) count (M/mm3) | Blood samples will be collected for the assessment of hematology parameters | Up to Day 21 |
| Values of sodium, potassium, chloride (mmol/L) | Blood samples will be collected for the assessment of clinical chemistry parameters | Up to Day 21 |
| Values of urea, phosphorus, calcium, glucose, and total, direct and indirect bilirubin (mg/dL) | Blood samples will be collected for the assessment of clinical chemistry parameters | Up to Day 21 |
| Values of albumin and total protein (g/dL) | Blood samples will be collected for the assessment of clinical chemistry parameters | Up to Day 21 |
| Values of alanine aminotransferase (ALT), aspartate aminotransferase (AST),alkaline phosphatase (ALP), gamma glutamyl transferase (GGT), creatininephosphokinase (CPK), and creatinine (U/L) | Blood samples will be collected for the assessment of clinical chemistry parameters | Up to Day 21 |
| Values of urine specific gravity | Urine samples will be collected for the assessment of urine parameters | Up to Day 21 |
| Values of urine pH | Urine samples will be collected for the assessment of urine parameters | Up to Day 21 |
| Values of urine glucose | Urine samples will be collected for the assessment of urine parameters | Up to Day 21 |
| Values of urine protein | Urine samples will be collected for the assessment of urine parameters | Up to Day 21 |
| Values of urine blood | Urine samples will be collected for the assessment of urine parameters | Up to Day 21 |
| Values of urine ketones | Urine samples will be collected for the assessment of urine parameters | Up to Day 21 |
| Values of urine bilirubin and nitrite | Urine samples will be collected for the assessment of urine parameters | Up to Day 21 |
| Values of urobilinogen | Urine samples will be collected for the assessment of urine parameters | Up to Day 21 |
| Values of urine leukocyte esterase by dipstick | Urine samples will be collected for the assessment of urine parameters | Up to Day 21 |
| D010879 |
| Piperazines |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |