Drug-InteractionsPhase 1NCT04764851
Drug-Drug Interaction Study to Evaluate the Effects of Ecopipam on the Pharmacokinetics of Multiple Substrates
A Phase 1 study testing ecopipam HCl ~2mg/kg/day, Cohort 1 Probe Cocktail and Cohort 2 Probe Cocktail in people with Drug-Interactions, run by Emalex Biosciences Inc. at 1 site in United States.
Trial summary
This is a single center, open-label, fixed sequence Phase 1, 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-Interactions
- What is being tested?
- ecopipam HCl ~2mg/kg/day, Cohort 1 Probe Cocktail and Cohort 2 Probe Cocktail
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2021to 7 May 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 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
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
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- 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
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 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.
Read the 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).
- Conditions
- Drug-Interactions
- Being tested
- ecopipam HCl ~2mg/kg/day, Cohort 1 Probe Cocktail, Cohort 2 Probe Cocktail, Cohort 3 Probe Cocktail
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ecopipam HCl ~2mg/kg/dayDrug
oral tablet
Cohort 1 Probe CocktailCombination product
dextromethorphan, caffeine, omeprazole, and midazolam
Cohort 2 Probe CocktailCombination product
dabigatran, pitavastatin, rosuvastatin, atorvastatin, midazolam
Cohort 3 Probe CocktailCombination product
bupropion
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Other | 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 Receives: Drug: ecopipam HCl ~2mg/kg/day; Combination Product: Cohort 1 Probe Cocktail |
| Cohort 2 | Other | 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 Receives: Drug: ecopipam HCl ~2mg/kg/day; Combination Product: Cohort 2 Probe Cocktail |
| Cohort 3 | Other | 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 Receives: Drug: ecopipam HCl ~2mg/kg/day; Combination Product: Cohort 3 Probe Cocktail |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to Day 18
Secondary outcomes (122)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to Day 18
Total concentration of bilirubin in the presence of ecopipam
Bilirubin sampling will occur on Day 1 and Day 13
Measured: Up to Day 13
Total concentration of bilirubin in the absence of ecopipam
Bilirubin sampling will occur on Day 1 and Day 13
Measured: Up to Day 13
Unconjugated concentration of bilirubin in the presence of ecopipam
Bilirubin sampling will occur on Day 1 and Day 13
Measured: Up to Day 13
Unconjugated concentration of bilirubin in the absence of ecopipam
Bilirubin sampling will occur on Day 1 and Day 13
Measured: Up to Day 13
Safety and tolerability as demonstrated by MOAA/S
Safety and tolerability measures will be recorded at the indicated timepoints.
Measured: Up to Day 55
Safety and tolerability as demonstrated by C-SSRS
Safety and tolerability measures will be recorded at the indicated timepoints.
Measured: Up to Day 55
Safety and tolerability as demonstrated by concomitant medications
Safety and tolerability measures will be recorded at the indicated timepoints.
Measured: Up to Day 55
AEs with relatedness associated with dextromethorphan
Subjects will be continually monitored for adverse events
Measured: Up to Day 55
AEs with relatedness associated with IV midazolam
Subjects will be continually monitored for adverse events
Measured: Up to Day 55
AEs with relatedness associated with oral midazolam
Subjects will be continually monitored for adverse events
Measured: Up to Day 55
AEs with relatedness associated with dabigatran
Subjects will be continually monitored for adverse events
Measured: Up to Day 55
AEs with relatedness associated with pitavastatin
Subjects will be continually monitored for adverse events
Measured: Up to Day 55
AEs with relatedness associated with rosuvastatin
Subjects will be continually monitored for adverse events
Measured: Up to Day 55
AEs with relatedness associated with atorvastatin
Subjects will be continually monitored for adverse events
Measured: Up to Day 55
AEs with relatedness associated with bupropion
Subjects will be continually monitored for adverse events
Measured: Up to Day 55
AEs with relatedness associated with caffeine
Subjects will be continually monitored for adverse events
Measured: Up to Day 55
AEs with relatedness associated with omeprazole
Subjects will be continually monitored for adverse events
Measured: Up to Day 55
AEs with relatedness associated with ecopipam
Subjects will be continually monitored for adverse events
Measured: 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.
Measured: Up to Day 25
Absolute values of neutrophils, lymphocytes, monocytes, eosinophils, and basophils (10E3/uL)
Up to Day 25
Measured: 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.
Measured: Up to Day 25
Absolute values of hematocrit (%)
Blood samples will be collected for the assessment of hematology parameters.
Measured: Up to Day 25
Absolute values of hemoglobin (g/dL)
Blood samples will be collected for the assessment of hematology parameters.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Day 25
Absolute values of urine specific gravity
Urine samples will be collected for the assessment of urine parameters.
Measured: Up to Day 25
Absolute values of urine pH
Urine samples will be collected for the assessment of urine parameters.
Measured: Up to Day 25
Absolute values of urine glucose
Urine samples will be collected for the assessment of urine parameters.
Measured: Up to Day 25
Absolute values of urine protein
Urine samples will be collected for the assessment of urine parameters.
Measured: Up to Day 25
Absolute values of urine blood
Urine samples will be collected for the assessment of urine parameters.
Measured: Up to Day 25
Absolute values of urine ketones
Urine samples will be collected for the assessment of urine parameters.
Measured: Up to Day 25
Absolute values of urine bilirubin, urobilinogen, and nitrite
Urine samples will be collected for the assessment of urine parameters.
Measured: Up to Day 25
Absolute values of urine leukocytes by dipstick
Urine samples will be collected for the assessment of urine parameters.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
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.
Measured: Up to Day 25
Absolute values of oral temperature (degrees Celsius)
Temperature will be assessed as part of vital signs.
Measured: 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.
Measured: Up to Day 25
Absolute values of heart rate (beats/minute)
Heart rate will be assessed as part of vital signs.
Measured: 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.
Measured: Up to Day 25
Absolute values of respiratory rate (breaths/minute)
Respiratory rate will be assessed as part of vital signs.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Day 25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start18 Feb 2021
- Primary completion2 Apr 2021
- Study completion7 May 2021
Why it stopped: A number of subjects withdrew consent leaving the study without adequate power to achieve its primary end points.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-InteractionsStudies 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
- 30 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
- NCT04764851
- Sponsor's protocol ID
- EBS-101-HV-101
- Status last verified
- Apr 2021
- First submitted
- 18 Jan 2021
- Last updated
- 24 May 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 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 Effects of Repeat Doses of Ecopipam on the Pharmacokinetics of Multiple Substrates for Drug Metabolism and Transport in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04764851
- Acronym / sponsor ID
- EBS-101-HV-101
- Conditions
- Drug-Interactions
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: A number of subjects withdrew consent leaving the study without adequate power to achieve its primary end points.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Emalex Biosciences Inc.Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health, Nuventra, Inc.
- Study start
- 18 Feb 2021 (actual)
- Primary completion
- 2 Apr 2021 (actual)
- Study completion
- 7 May 2021 (actual)
- First posted
- 21 Feb 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 Phase 1, drug-drug interaction (DDI) study in healthy subjects.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Other | Drug: ecopipam HCl ~2mg/kg/day, Combination Product: Cohort 1 Probe Cocktailecopipam 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 |
| Cohort 2 | Other | Drug: ecopipam HCl ~2mg/kg/day, Combination Product: Cohort 2 Probe Cocktailecopipam 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 |
| Cohort 3 | Other | Drug: ecopipam HCl ~2mg/kg/day, Combination Product: Cohort 3 Probe Cocktailecopipam 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 |
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 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
Key exclusion criteria (16 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 HCl ~2mg/kg/dayoral tablet | Drug | Cohort 1, Cohort 2, Cohort 3 |
| Cohort 1 Probe Cocktaildextromethorphan, caffeine, omeprazole, and midazolam | Combination product | Cohort 1 |
| Cohort 2 Probe Cocktaildabigatran, pitavastatin, rosuvastatin, atorvastatin, midazolam | Combination product | Cohort 2 |
| Cohort 3 Probe Cocktailbupropion | Combination product | Cohort 3 |
Primary outcome
Cmax of dextromethorphan (and its dextrorphan metabolite) in the presence of ecopipam
Time frame: Up to Day 18
Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Cmax of dextromethorphan (and its dextrorphan metabolite) in the absence of ecopipam
Time frame: Up to Day 18
Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Cmax of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam
Time frame: Up to Day 18
Up to 38 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
Time frame: Up to Day 18
Up to 38 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
Time frame: Up to Day 18
Up to 38 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
Time frame: Up to Day 18
Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Cmax of dabigatran in the presence of ecopipam
Time frame: Up to Day 18
Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Cmax of dabigatran in the absence of ecopipam
Time frame: Up to Day 18
Up to 38 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
Time frame: Up to Day 18
Up to 38 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
Time frame: Up to Day 18
Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Cmax of rosuvastatin in the presence of ecopipam
Time frame: Up to Day 18
Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis
Cmax of rosuvastatin in the absence of ecopipam
Time frame: Up to Day 18
Up to 38 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
Time frame: Up to Day 18
Up to 38 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
Time frame: Up to Day 18
Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUCinf of dextromethorphan (and its dextrorphan metabolite) in the presence of ecopipam
Time frame: Up to Day 18
Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUCinf of dextromethorphan (and its dextrorphan metabolite) in the absence of ecopipam
Time frame: Up to Day 18
Up to 38 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
Time frame: Up to Day 18
Up to 38 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
Time frame: Up to Day 18
Up to 38 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
Time frame: Up to Day 18
Up to 38 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
Time frame: Up to Day 18
Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUCinf of dabigatran in the presence of ecopipam
Time frame: Up to Day 18
Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic analysis
AUCinf of dabigatran in the absence of ecopipam
Time frame: Up to Day 18
Up to 38 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
Time frame: Up to Day 18
Up to 38 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
Time frame: Up to Day 18
Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic
AUCinf of rosuvastatin in the presence of ecopipam
Time frame: Up to Day 18
Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic
AUCinf of rosuvastatin in the absence of ecopipam
Time frame: Up to Day 18
Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic
AUCinf of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the presence of ecopipam
Time frame: Up to Day 18
Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic
AUCinf of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the absence of ecopipam
Time frame: Up to Day 18
Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic
AUClast of dextromethorphan (and its dextrorphan metabolite) in the presence of ecopipam
Time frame: Up to Day 18
Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic
AUClast of dextromethorphan (and its dextrorphan metabolite) in the absence of ecopipam
Time frame: Up to Day 18
Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic
AUClast of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam
Time frame: Up to Day 18
Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic
AUClast of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam
Time frame: Up to Day 18
Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic
AUClast of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam
Time frame: Up to Day 18
Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic
AUClast of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam
Time frame: Up to Day 18
Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic
AUClast of dabigatran in the presence of ecopipam
Time frame: Up to Day 18
Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic
AUClast of dabigatran in the absence of ecopipam
Time frame: Up to Day 18
Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic
AUClast of pitavastatin (and its pitavastatin lactone metabolite) in the presence of ecopipam
Time frame: Up to Day 18
Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic
AUClast of pitavastatin (and its pitavastatin lactone metabolite) in the absence of ecopipam
Time frame: Up to Day 18
Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic
AUClast of rosuvastatin in the presence of ecopipam
Time frame: Up to Day 18
Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic
AUClast of rosuvastatin in the absence of ecopipam
Time frame: Up to Day 18
Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic
AUClast of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the presence of ecopipam
Time frame: Up to Day 18
Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic
AUClast of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the absence of ecopipam
Time frame: Up to Day 18
Up to 38 blood samples will be collected at the indicated time points for pharmacokinetic
122 secondary outcomes
Cmax of bupropion (and its 4-hydroxybupropion metabolite) in the presence of ecopipam
Time frame: Up to Day 18
Cmax of bupropion (and its 4-hydroxybupropion metabolite) in the absence of ecopipam
Time frame: Up to Day 18
Cmax of caffeine (and its metabolite paraxanthine) in the presence of ecopipam
Time frame: Up to Day 18
Cmax of caffeine (and its metabolite paraxanthine) in the absence of ecopipam
Time frame: Up to Day 18
Cmax omeprazole (and its 5'-hydroxy omeprazole metabolite) in the presence of ecopipam
Time frame: Up to Day 18
Cmax omeprazole (and its 5'-hydroxy omeprazole metabolite) in the absence of ecopipam
Time frame: Up to Day 18
AUCinf of bupropion (and its 4-hydroxybupropion metabolite) in the presence of ecopipam
Time frame: Up to Day 18
AUCinf of bupropion (and its 4-hydroxybupropion metabolite) in the absence of ecopipam
Time frame: Up to Day 18
AUCinf of caffeine (and its metabolite paraxanthine) in the presence of ecopipam
Time frame: Up to Day 18
AUCinf of caffeine (and its metabolite paraxanthine) in the absence of ecopipam
Time frame: Up to Day 18
AUCinf of omeprazole (and its 5'-hydroxy omeprazole metabolite) in the presence of ecopipam
Time frame: Up to Day 18
AUCinf of omeprazole (and its 5'-hydroxy omeprazole metabolite) in the absence of ecopipam
Time frame: Up to Day 18
AUClast of bupropion (and its 4-hydroxybupropion metabolite) in the presence of ecopipam
Time frame: Up to Day 18
AUClast of bupropion (and its 4-hydroxybupropion metabolite) in the absence of ecopipam
Time frame: Up to Day 18
AUClast of caffeine (and its metabolite paraxanthine) in the presence of ecopipam
Time frame: Up to Day 18
AUClast of caffeine (and its metabolite paraxanthine) in the absence of ecopipam
Time frame: Up to Day 18
AUClast of omeprazole (and its 5'-hydroxy omeprazole metabolite) in the presence of ecopipam
Time frame: Up to Day 18
AUClast of omeprazole (and its 5'-hydroxy omeprazole metabolite) in the absence of ecopipam
Time frame: Up to Day 18
CL/F for dextromethorphan in the presence of ecopipam
Time frame: Up to Day 18
CL/F for dextromethorphan in the absence of ecopipam
Time frame: Up to Day 18
CL/F for IV midazolam in the presence of ecopipam
Time frame: Up to Day 18
CL/F for IV midazolam in the absence of ecopipam
Time frame: Up to Day 18
CL/F for oral midazolam in the presence of ecopipam
Time frame: Up to Day 18
CL/F for oral midazolam in the absence of ecopipam
Time frame: Up to Day 18
CL/F for dabigatran in the presence of ecopipam
Time frame: Up to Day 18
CL/F for dabigatran in the absence of ecopipam
Time frame: Up to Day 18
CL/F for pitavastatin in the presence of ecopipam
Time frame: Up to Day 18
CL/F for pitavastatin in the absence of ecopipam
Time frame: Up to Day 18
CL/F for rosuvastatin in the presence of ecopipam
Time frame: Up to Day 18
CL/F for rosuvastatin in the absence of ecopipam
Time frame: Up to Day 18
CL/F for atorvastatin in the presence of ecopipam
Time frame: Up to Day 18
CL/F for atorvastatin in the absence of ecopipam
Time frame: Up to Day 18
CL/F for bupropion in the presence of ecopipam
Time frame: Up to Day 18
CL/F for bupropion in the absence of ecopipam
Time frame: Up to Day 18
CL/F for caffeine in the presence of ecopipam
Time frame: Up to Day 18
CL/F for caffeine in the absence of ecopipam
Time frame: Up to Day 18
CL/F for omeprazole in the presence of ecopipam
Time frame: Up to Day 18
CL/F for omeprazole in the absence of ecopipam
Time frame: Up to Day 18
V/F for dextromethorphan in the presence of ecopipam
Time frame: Up to Day 18
V/F for dextromethorphan in the absence of ecopipam
Time frame: Up to Day 18
Results and safety
The study was stopped early (reason given: A number of subjects withdrew consent leaving the study without adequate power to achieve its primary end points.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
- Individual participant dataSharing planned: No
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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 ~2mg/kg/day, Cohort 1 Probe Cocktail and Cohort 2 Probe Cocktail in people with Drug-Interactions, 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 16 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: stopped early, as of the sponsor's last update on 24 May 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 was stopped early (reason given: A number of subjects withdrew consent leaving the study without adequate power to achieve its primary end points.). Results are not available in the source record.
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 dextromethorphan (and its dextrorphan metabolite) in the presence of ecopipam (time frame: Up to Day 18). The study lists 42 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 24 May 2021.