Ecopipam - Drug Interaction | Phase 1 | Icon Plc | BiopharmaWatch

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Ecopipam

Phase 1

Drug Interaction | Small molecule | Other |Icon Plc|Last Updated: Dec 12, 2022

Success Probability

Approval Probability 71%

TA Base Rate26%

Adjusted LOA41%

ML RiskLOW_RISK

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Market & Valuation

rNPV $3.2B

Market Size $9.4B

Revenue Basis $1.6B

Competitors 6

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Trial Design

CONTROLLEDBiomarker

Total Trials1

Total Enrollment56

FDA Designations

No designations recorded

Clinical Trials (1)

NCT ID	Title	Phase	Status	Enrollment	Velocity	Design	Start	Completion	Last Updated	Sites	Countries
NCT05334108	Drug-Drug Interaction Study to Evaluate the Effects of Ecopipam on the Pharmacokinetics of Multiple Substrates for Drug Metabolism and Transport	PHASE1	COMPLETED	56	—	—	Apr 26, 2022	Aug 26, 2022	Dec 12, 2022	1	United States

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Study Endpoints

Primary Endpoints

Cmax of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

Cmax of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

Cmax of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

Cmax oral midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

Cmax of dabigatran in the presence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

Cmax of dabigatran in the absence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

Cmax of pitavastatin (and its pitavastatin lactone metabolite) in the presence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

Cmax of pitavastatin (and its pitavastatin lactone metabolite) in the absence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

Cmax of rosuvastatin in the presence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

Cmax of rosuvastatin in the absence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

Cmax of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the presence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

Cmax of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the absence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

AUCinf of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

AUCinf of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

AUCinf of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

AUCinf of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

AUCinf of dabigatran in the presence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

AUCinf of dabigatran in the absence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

AUCinf of pitavastatin (and its pitavastatin lactone metabolite) in the presence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

AUCinf of pitavastatin (and its pitavastatin lactone metabolite) in the absence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

AUCinf of rosuvastatin in the presence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

AUCinf of rosuvastatin in the absence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

AUCinf of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the presence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

AUCinf of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the absence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

AUClast of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

AUClast of IV midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

AUClast of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

AUClast of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

AUClast of dabigatran in the presence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

AUClast of dabigatran in the absence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

AUClast of pitavastatin (and its pitavastatin lactone metabolite) in the presence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

AUClast of pitavastatin (and its pitavastatin lactone metabolite) in the absence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

AUClast of rosuvastatin in the presence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

AUClast of rosuvastatin in the absence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

AUClast of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the presence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

AUClast of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the absence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

AUC0-24 of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the presence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

AUC0-24 of oral midazolam (and its 1'-hydroxymidazolam metabolite) in the absence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

AUC0-24 of dabigatran in the presence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

AUC0-24 of dabigatran in the absence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

AUC0-24 of pitavastatin (and its pitavastatin lactone metabolite) in the presence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

AUC0-24 of pitavastatin (and its pitavastatin lactone metabolite) in the absence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

AUC0-24 of rosuvastatin in the presence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

AUC0-24 of rosuvastatin in the absence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

AUC0-24 of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the presence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

AUC0-24 of atorvastatin (and its 4'-hydroxy atorvastatin metabolite) in the absence of ecopipam

Up to Day 22

Up to 46 blood samples will be collected at the indicated time points for pharmacokinetic analysis

Secondary Endpoints

Cmax of bupropion (and its 4-hydroxybupropion metabolite) in the presence of ecopipam

Up to Day 22

Cmax of bupropion (and its 4-hydroxybupropion metabolite) in the absence of ecopipam

Up to Day 22

Cmax omeprazole (and its 5'-hydroxy omeprazole metabolite) in the presence of ecopipam

Up to Day 22

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Study Design & Arms

AllocationNON_RANDOMIZED

MaskingNONE

ModelPARALLEL

PurposeBASIC_SCIENCE

Treatment Arms

Arm	Type	Description
Cohort 1	OTHER	ecopipam HCl oral tablets of 12.5, 50, 75, and 100 mg daily for up to 20 days Cohort 1 Probe Substrate Cocktail given on 2 separate days: * midazolam: 1 µg infused IV * caffeine: 200 mg oral tablet * omeprazole: two 20 mg oral tablets * dextromethorphan: 1.6mL (containing \~10 mg) oral solution
Cohort 2	OTHER	ecopipam HCl oral tablets of 12.5, 50, 75, and 100 mg daily for up to 20 days Cohort 2 Probe Substrate given on 2 separate days: \- bupropion: 100mg oral tablet
Cohort 3	OTHER	ecopipam HCl oral tablets of 12.5, 50, 75, and 100 mg daily for up to 20 days Cohort 3 Probe Substrate Cocktail given on 3 separate days: * midazolam: 10 µg/mL given as 1mL oral solution. * dabigatran: 375 µg/mL and pitavastatin: 10 µg/mL given as 1mL oral solution * rosuvastatin: 25 µg/mL and atorvastatin: 50 µg/mL given as 2mL oral solution

Interventions

Name	Type	Description
Ecopipam	DRUG	ecopipam HCl \~2mg/kg/day
Cohort 1 Probe Substrate Cocktail	COMBINATION_PRODUCT	dextromethorphan, caffeine, omeprazole, and midazolam
Cohort 2 Probe Substrate	DRUG	bupropion
Cohort 3 Probe Substrate Cocktail	COMBINATION_PRODUCT	dabigatran, pitavastatin, rosuvastatin, atorvastatin, midazolam

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Eligibility Criteria

Age Range18 Years — 55 Years

SexALL

Healthy VolunteersYes

Study Sites1

Inclusion Criteria: * Male subjects or female subjects of non-childbearing potential * ≥18 and \<55 years of age at the time of consent * BMI \>18.5 and \<30 kg/m2 and a weight of ≥50 kg for males or ≥45 kg for females * Subjects must be healthy, as determined by the Investigator, based on medical ...

Countries:United States

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