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-olinciguat

Phase 1

Healthy Volunteers | Small molecule | Other |Cyclerion Therapeutics, Inc.|Last Updated: Apr 3, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment8
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03795519A Trial to Study the Absorption, Metabolism, and Excretion of [14C]-Olinciguat in Healthy Male VolunteersPHASE1 COMPLETED 8 — — Jan 17, 2019Feb 27, 2019Apr 3, 20191 United States
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Study Endpoints
Primary Endpoints
Amount of total radioactivity excreted in urine (Aeu) and feces (Aef)
up to Day 15
Cumulative Aeu and cumulative Aef
up to Day 15
Percentage of total radioactivity excreted in urine (feu) and feces (fef)
up to Day 15
Cumulative feu and cumulative fef
up to Day 15
Percentage of total radioactivity in total excreta (feces + urine)
up to Day 15
Area under the concentration-time curve (AUC) from time zero to infinity (AUC0-inf) of olinciguat in plasma
up to Day 15
AUC0-inf of total radioactivity in plasma and whole blood
up to Day 15
AUC from time zero to the last quantifiable concentration (AUC0-last) of olinciguat in plasma
up to Day 15
AUC0-last of total radioactivity in plasma and whole blood
up to Day 15
Maximum observed concentration (Cmax) of olinciguat in plasma
up to Day 15
Cmax of total radioactivity in plasma and whole blood
up to Day 15
Time of Cmax (Tmax) of olinciguat in plasma
up to Day 15
Tmax of total radioactivity in plasma and whole blood
up to Day 15
Apparent terminal elimination half-life (t1/2) of olinciguat in plasma
up to Day 15
t1/2 total radioactivity in plasma and whole blood
up to Day 15
Apparent total clearance of olinciguat (CL/F)
up to Day 15
Apparent volume of distribution of olinciguat (Vz/F)
up to Day 15
AUC0-inf of plasma olinciguat concentration relative to AUC0-inf of plasma total radioactivity (AUC0-inf Ratio of Plasma Olinciguat/Plasma Total Radioactivity)
up to Day 15
AUC0-inf of whole blood total radioactivity to AUC0-inf of plasma total radioactivity (AUC0-inf Ratio of Blood Total Radioactivity/Plasma Total Radioactivity)
up to Day 15
Secondary Endpoints
Levels of metabolite radioactivity excreted in urine and feces
up to Day 15
AUC0-inf of metabolite radioactivity levels in plasma
up to Day 15
AUC0-inf of plasma metabolite radioactivity levels relative to AUC0-inf of plasma total radioactivity (Plasma AUC0-inf Ratio of Metabolite Radioactivity/Total Radioactivity)
up to Day 15
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER
Treatment Arms
ArmTypeDescription
Healthy Male VolunteersEXPERIMENTALSingle oral dose of \[14C\]-olinciguat
Interventions
NameTypeDescription
[14C]-olinciguatDRUGoral capsule
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Males of any race, between 18 and 55 years of age, inclusive * Body mass index between 18 and 32 kg/m2, inclusive * Subject is in good health and has no clinically significant findings on physical examination * Men must agree to use protocol-specified contraception and also to...

Countries:United States
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