Drug InteractionPhase 1NCT04902105
Drug-Drug Interaction Study to Evaluate the Effect of Inhibition of UGTs on the PK of Ecopipam and Its Active Metabolite
A Phase 1 study testing ecopipam HCL, Mefenamic acid and Divalproex Sodium ER in people with Drug Interaction, run by Emalex Biosciences Inc. at 1 site in United States.
Trial summary
This is a single center, open-label, fixed sequence, drug-drug interaction (DDI) study in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Interaction
- What is being tested?
- ecopipam HCL, Mefenamic acid and Divalproex Sodium ER
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2021to 6 Jul 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
- 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
- Not suitable for study in the opinion of the Principal Investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
Syneos Health Clinical Research Services, LLC.
Miami, Florida, 33136
About this study
Official title: A Phase 1, Open-Label, Fixed Sequence, Drug-Drug Interaction Study to Evaluate the Effect of Inhibition of Uridine 5'-Diphosphate-glucuronosyltransferases (UGTs) on the Pharmacokinetics of Ecopipam Tablets and Its Active Metabolite (EBS-101-40853) in Healthy Subjects
This is a single center, open-label, fixed sequence, drug-drug interaction (DDI) study in healthy subjects.
Read the detailed description
Following a 28-day Screening period, eligible subjects will enter the clinical research unit (CRU) and will be enrolled into either Cohort A or B. Subjects in both cohorts will receive a single dose of ecopipam on Day 1. On Day 7, subjects will begin taking a UGT inhibitor according to their assigned cohort. Subjects in Cohort A will receive mefenamic acid 250 mg every 6 hours for 7 days, while subjects in Cohort B will receive divalproex sodium ER 1250 mg once a day for 10 days. A single oral dose of ecopipam will also be administered to Cohort A on Day 7, 1 hour after the first dose of mefenamic acid, and to Cohort B on Day 10, 1 hour after administration of divalproex sodium ER. Subjects in Cohort A will continue taking mefenamic acid through the evening of Day 13 and will remain in the CRU until discharged on Day 14/ET. Subjects in Cohort B will continue taking divalproex sodium ER through Day 16 and will remain in the CRU until discharge on Day 17/ET.
- Conditions
- Drug Interaction
- Being tested
- ecopipam HCL, Mefenamic acid, Divalproex Sodium ER
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ecopipam HCLDrug
oral tablets
Mefenamic acidDrug
oral capsules
Divalproex Sodium ERDrug
oral tablets
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Other | Ecopipam HCL - 2 doses of 200mg
Mefenamic acid 250mg Q6H for 7 days Receives: Drug: ecopipam HCL; Drug: Mefenamic acid |
| Cohort B | Other | Ecopipam HCL - 2 doses of 200mg
Divalproex acid 1250mg QD for 10 days Receives: Drug: ecopipam HCL; Drug: Divalproex Sodium ER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of ecopipam in the presence of mefenamic acid
Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 16
Cmax of ecopipam in the absence of mefenamic acid
Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 16
Cmax of ecopipam in the presence of divalproex sodium ER
Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 16
Cmax of ecopipam in the absence of divalproex sodium ER
Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 16
AUCinf of ecopipam in the presence of mefenamic acid
Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 16
AUCinf of ecopipam in the absence of mefenamic acid
Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 16
AUCinf of ecopipam in the presence of divalproex sodium ER
Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 16
AUCinf of ecopipam in the absence of divalproex sodium ER
Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 16
AUC0-143 of ecopipam in the presence of mefenamic acid
Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 16
AUC0-143 of ecopipam in the absence of mefenamic acid
Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 16
AUC0-143 of ecopipam in the presence of divalproex sodium ER
Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 16
AUC0-143 of ecopipam in the absence of divalproex sodium ER
Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 16
Secondary outcomes (63)
Cmax of EBS-101-40853
Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 16
AUCinf of EBS-101-40853
Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 16
AUC0-143 of EBS-101-40853
Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 16
Cmax of mefenamic acid
Up to 15 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 16
Tmax of mefenamic acid
Up to 15 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 16
AUCtau of mefenamic acid
Up to 15 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 16
t½ of mefenamic acid
Up to 15 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 16
Cmax of VPA
Up to 19 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 16
Tmax of VPA
Up to 19 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 16
AUCtau of VPA
Up to 19 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Measured: Up to Day 16
Safety and tolerability as demonstrated by MOAA/S
Safety and tolerability measures will be recorded at the indicated timepoints.
Measured: Up to Day 17
Safety and tolerability as demonstrated by C-SSRS
Safety and tolerability measures will be recorded at the indicated timepoints.
Measured: Up to Day 17
Safety and tolerability as demonstrated by concomitant medications
Safety and tolerability measures will be recorded at the indicated timepoints.
Measured: Up to Day 42
AEs with relatedness associated with mefenamic acid
Subjects will be continually monitored for adverse events
Measured: Up to Day 42
AEs with relatedness associated with divalproex sodium ER
Subjects will be continually monitored for adverse events
Measured: Up to Day 42
AEs with relatedness associated with ecopipam
Subjects will be continually monitored for adverse events
Measured: Up to Day 42
Absolute values of white blood cell (WBC) count (K/Ul)
Blood samples will be collected for the assessment of hematology parameters.
Measured: Up to Day 17
Absolute values of neutrophils, lymphocytes, monocytes, eosinophils, and basophils (10E3/uL)
Blood samples will be collected for the assessment of hematology parameters.
Measured: Up to Day 17
Absolute values of platelets (K/uL)
Blood samples will be collected for the assessment of hematology parameters.
Measured: Up to Day 17
Absolute values of hematocrit (%)
Blood samples will be collected for the assessment of hematology parameters.
Measured: Up to Day 17
Absolute values of hemoglobin (g/dL)
Blood samples will be collected for the assessment of hematology parameters.
Measured: Up to Day 17
Absolute values of Red blood cell (RBC) count (M/uL)
Blood samples will be collected for the assessment of hematology parameters.
Measured: Up to Day 17
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.
Measured: Up to Day 17
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.
Measured: Up to Day 17
Absolute values of albumin and total protein (g/dL)
Blood samples will be collected for the assessment of clinical chemistry parameters.
Measured: Up to Day 17
Absolute values of alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma glutamyl transferase (GGT), and creatinine phosphokinase (CPK)
Blood samples will be collected for the assessment of clinical chemistry parameters.
Measured: Up to Day 17
Absolute values of urine specific gravity
Urine samples will be collected for the assessment of urine parameters.
Measured: Up to Day 17
Absolute values of urine pH
Urine samples will be collected for the assessment of urine parameters.
Measured: Up to Day 17
Absolute values of urine glucose
Urine samples will be collected for the assessment of urine parameters.
Measured: Up to Day 17
Absolute values of urine protein
Urine samples will be collected for the assessment of urine parameters.
Measured: Up to Day 17
Absolute values of urine blood
Urine samples will be collected for the assessment of urine parameters.
Measured: Up to Day 17
Absolute values of urine ketones
Urine samples will be collected for the assessment of urine parameters.
Measured: Up to Day 17
Absolute values of urine bilirubin, urobilinogen, and nitrite
Urine samples will be collected for the assessment of urine parameters.
Measured: Up to Day 17
Absolute values of urine leukocytes by dipstick
Urine samples will be collected for the assessment of urine parameters.
Measured: Up to Day 17
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.
Measured: Up to Day 17
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.
Measured: Up to Day 17
Change from Day -1 to Day of Discharge in platelets (K/uL)
Blood samples will be collected for the assessment of hematology parameters.
Measured: Up to Day 17
Change from Day -1 to Day of Discharge in hematocrit (%)
Blood samples will be collected for the assessment of hematology parameters.
Measured: Up to Day 17
Change from Day -1 to Day of Discharge in hemoglobin (g/dL)
Blood samples will be collected for the assessment of hematology parameters.
Measured: Up to Day 17
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.
Measured: Up to Day 17
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.
Measured: Up to Day 17
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.
Measured: Up to Day 17
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.
Measured: Up to Day 17
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.
Measured: Up to Day 17
Change from Day -1 to Day of Discharge in urine specific gravity
Urine samples will be collected for the assessment of urine parameters.
Measured: Up to Day 17
Change from Day -1 to Day of Discharge in urine pH
Urine samples will be collected for the assessment of urine parameters.
Measured: Up to Day 17
Change from Day -1 to Day of Discharge in urine glucose
Urine samples will be collected for the assessment of urine parameters.
Measured: Up to Day 17
Change from Day -1 to Day of Discharge in urine protein
Urine samples will be collected for the assessment of urine parameters.
Measured: Up to Day 17
Change from Day -1 to Day of Discharge in urine blood
Urine samples will be collected for the assessment of urine parameters.
Measured: Up to Day 17
Change from Day -1 to Day of Discharge in urine ketones
Urine samples will be collected for the assessment of urine parameters.
Measured: Up to Day 17
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.
Measured: Up to Day 17
Change from Day -1 to Day of Discharge in urine leukocytes by dipstick
Urine samples will be collected for the assessment of urine parameters.
Measured: Up to Day 17
Change from Day 6 to Day of Discharge in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) (U/L)
Blood samples will be collected for the assessment of clinical chemistry parameters.
Measured: Up to Day 17
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.
Measured: Up to Day 10
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.
Measured: Up to Day 10
Absolute values of oral temperature (degrees Celsius)
Temperature will be assessed as part of vital signs.
Measured: Up to Day 17
Change from pre-dose for the respective day in oral temperature (degrees Celsius)
Temperature will be assessed as part of vital signs.
Measured: Up to Day 17
Absolute values of heart rate (beats/minute)
Heart rate will be assessed as part of vital signs.
Measured: Up to Day 17
Change from pre-dose for the respective day in heart rate (beats/minute)
Heart rate will be assessed as part of vital signs.
Measured: Up to Day 17
Absolute values of respiratory rate (breaths/minute)
Respiratory rate will be assessed as part of vital signs.
Measured: Up to Day 17
Change from pre-dose for the respective day in respiratory rate (breaths/minute)
Respiratory rate will be assessed as part of vital signs.
Measured: Up to Day 17
Absolute values of systolic blood pressure (SBP) and diastolic blood pressure (DBP) (mmHG)
Blood pressure will be assessed as part of vital signs.
Measured: Up to Day 17
Change from pre-dose for the respective day in SBP and DBP (mmHG)
Blood pressure will be assessed as part of vital signs.
Measured: Up to Day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start13 May 2021
- Primary completion6 Jul 2021
- Study completion6 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug InteractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emalex Biosciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health, Nuventra, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04902105
- Sponsor's protocol ID
- EBS-101-HV-102
- Status last verified
- Jul 2021
- First submitted
- 20 May 2021
- Last updated
- 22 Jul 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Fixed Sequence, Drug-Drug Interaction Study to Evaluate the Effect of Inhibition of Uridine 5'-Diphosphate-glucuronosyltransferases (UGTs) on the Pharmacokinetics of Ecopipam Tablets and Its Active Metabolite (EBS-101-40853) in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04902105
- Acronym / sponsor ID
- EBS-101-HV-102
- Conditions
- Drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Emalex Biosciences Inc.Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health, Nuventra, Inc.
- Study start
- 13 May 2021 (actual)
- Primary completion
- 6 Jul 2021 (actual)
- Study completion
- 6 Jul 2021 (actual)
- First posted
- 26 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single center, open-label, fixed sequence, drug-drug interaction (DDI) study in healthy subjects.
Detailed description
Following a 28-day Screening period, eligible subjects will enter the clinical research unit (CRU) and will be enrolled into either Cohort A or B. Subjects in both cohorts will receive a single dose of ecopipam on Day 1. On Day 7, subjects will begin taking a UGT inhibitor according to their assigned cohort. Subjects in Cohort A will receive mefenamic acid 250 mg every 6 hours for 7 days, while subjects in Cohort B will receive divalproex sodium ER 1250 mg once a day for 10 days. A single oral dose of ecopipam will also be administered to Cohort A on Day 7, 1 hour after the first dose of mefenamic acid, and to Cohort B on Day 10, 1 hour after administration of divalproex sodium ER. Subjects in Cohort A will continue taking mefenamic acid through the evening of Day 13 and will remain in the CRU until discharged on Day 14/ET. Subjects in Cohort B will continue taking divalproex sodium ER through Day 16 and will remain in the CRU until discharge on Day 17/ET.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Other | Drug: ecopipam HCL, Drug: Mefenamic acidEcopipam HCL - 2 doses of 200mg Mefenamic acid 250mg Q6H for 7 days |
| Cohort B | Other | Drug: ecopipam HCL, Drug: Divalproex Sodium EREcopipam HCL - 2 doses of 200mg Divalproex acid 1250mg QD for 10 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ecopipam HCLoral tablets | Drug | Cohort A, Cohort B |
| Mefenamic acidoral capsules | Drug | Cohort A |
| Divalproex Sodium ERoral tablets | Drug | Cohort B |
Primary outcome
Cmax of ecopipam in the presence of mefenamic acid
Time frame: Up to Day 16
Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Cmax of ecopipam in the absence of mefenamic acid
Time frame: Up to Day 16
Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Cmax of ecopipam in the presence of divalproex sodium ER
Time frame: Up to Day 16
Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Cmax of ecopipam in the absence of divalproex sodium ER
Time frame: Up to Day 16
Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUCinf of ecopipam in the presence of mefenamic acid
Time frame: Up to Day 16
Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUCinf of ecopipam in the absence of mefenamic acid
Time frame: Up to Day 16
Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUCinf of ecopipam in the presence of divalproex sodium ER
Time frame: Up to Day 16
Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUCinf of ecopipam in the absence of divalproex sodium ER
Time frame: Up to Day 16
Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUC0-143 of ecopipam in the presence of mefenamic acid
Time frame: Up to Day 16
Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUC0-143 of ecopipam in the absence of mefenamic acid
Time frame: Up to Day 16
Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUC0-143 of ecopipam in the presence of divalproex sodium ER
Time frame: Up to Day 16
Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUC0-143 of ecopipam in the absence of divalproex sodium ER
Time frame: Up to Day 16
Up to 35 blood samples will be collected at the indicated time points for pharmacokinetic analysis
63 secondary outcomes
Cmax of EBS-101-40853
Time frame: Up to Day 16
AUCinf of EBS-101-40853
Time frame: Up to Day 16
AUC0-143 of EBS-101-40853
Time frame: Up to Day 16
Cmax of mefenamic acid
Time frame: Up to Day 16
Tmax of mefenamic acid
Time frame: Up to Day 16
AUCtau of mefenamic acid
Time frame: Up to Day 16
t½ of mefenamic acid
Time frame: Up to Day 16
Cmax of VPA
Time frame: Up to Day 16
Tmax of VPA
Time frame: Up to Day 16
AUCtau of VPA
Time frame: Up to Day 16
Safety and tolerability as demonstrated by MOAA/S
Time frame: Up to Day 17
Safety and tolerability as demonstrated by C-SSRS
Time frame: Up to Day 17
Safety and tolerability as demonstrated by concomitant medications
Time frame: Up to Day 42
AEs with relatedness associated with mefenamic acid
Time frame: Up to Day 42
AEs with relatedness associated with divalproex sodium ER
Time frame: Up to Day 42
AEs with relatedness associated with ecopipam
Time frame: Up to Day 42
Absolute values of white blood cell (WBC) count (K/Ul)
Time frame: Up to Day 17
Absolute values of neutrophils, lymphocytes, monocytes, eosinophils, and basophils (10E3/uL)
Time frame: Up to Day 17
Absolute values of platelets (K/uL)
Time frame: Up to Day 17
Absolute values of hematocrit (%)
Time frame: Up to Day 17
Absolute values of hemoglobin (g/dL)
Time frame: Up to Day 17
Absolute values of Red blood cell (RBC) count (M/uL)
Time frame: Up to Day 17
Absolute values of blood sodium, magnesium, urea, phosphorus, potassium, and chloride (mg/dL)
Time frame: Up to Day 17
Absolute values of creatinine, calcium, glucose, and direct and total bilirubin (mg/dL)
Time frame: Up to Day 17
Absolute values of albumin and total protein (g/dL)
Time frame: Up to Day 17
Absolute values of alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma glutamyl transferase (GGT), and creatinine phosphokinase (CPK)
Time frame: Up to Day 17
Absolute values of urine specific gravity
Time frame: Up to Day 17
Absolute values of urine pH
Time frame: Up to Day 17
Absolute values of urine glucose
Time frame: Up to Day 17
Absolute values of urine protein
Time frame: Up to Day 17
Absolute values of urine blood
Time frame: Up to Day 17
Absolute values of urine ketones
Time frame: Up to Day 17
Absolute values of urine bilirubin, urobilinogen, and nitrite
Time frame: Up to Day 17
Absolute values of urine leukocytes by dipstick
Time frame: Up to Day 17
Change from Day -1 to Day of Discharge in white blood cell (WBC) count (K/Ul)
Time frame: Up to Day 17
Change from Day -1 to Day of Discharge in neutrophils, lymphocytes, monocytes, eosinophils, and basophils (10E3/uL)
Time frame: Up to Day 17
Change from Day -1 to Day of Discharge in platelets (K/uL)
Time frame: Up to Day 17
Change from Day -1 to Day of Discharge in hematocrit (%)
Time frame: Up to Day 17
Change from Day -1 to Day of Discharge in hemoglobin (g/dL)
Time frame: Up to Day 17
Change from Day -1 to Day of Discharge in Red blood cell (RBC) count (M/uL)
Time frame: Up to Day 17
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ecopipam HCL, Mefenamic acid and Divalproex Sodium ER in people with Drug Interaction, run by Emalex Biosciences Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax of ecopipam in the presence of mefenamic acid (time frame: Up to Day 16). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2021.