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Olinciguat

Phase 1

Healthy | Small molecule | Other |Cyclerion Therapeutics, Inc.|Last Updated: Jul 15, 2019

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03892499A Trial to Evaluate the Effect of Itraconazole (ITZ), a CYP3A4 Inhibitor, on the Pharmacokinetics of the Soluble Guanylate Cyclase Stimulator, Olinciguat (IW-1701), in Healthy VolunteersPHASE1 COMPLETED 24 — — May 3, 2019Jul 3, 2019Jul 15, 20191 United States
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Study Endpoints
Primary Endpoints
Maximum Observed Plasma Concentration (Cmax) of olinciguat
Predose and up to 8 days post first olinciguat dose
Area under the plasma concentration time curve from time zero (predose) extrapolated to infinity (AUCinf)
Predose and up to 8 days post first olinciguat dose
Secondary Endpoints
Number of subjects with ≥1 treatment-emergent adverse event (TEAE) in Period 1 vs Period 2
51 days post first olinciguat dose
Cmax of Itraconazole
First Itraconazole dose up to day 8 of Period 2 (Period 2 duration can be up to 13 days)
Area under the concentration-time curve during a dosing interval (AUCtau) for itraconazole and hydroxy-itraconazole
Period 2 (Period 2 duration can be up to 13 days) predose and up to 24 hour after 2nd olinciguat dose
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER
Treatment Arms
ArmTypeDescription
Healthy VolunteersEXPERIMENTALPeriod 1: Single dose of olinciguat. Period 2: ITZ is dosed once daily (QD) for 10 days; a single dose of olinciguat is administered 1 hour after the fourth ITZ QD dose.
Interventions
NameTypeDescription
OlinciguatDRUGOral Tablet
ItraconazoleDRUGOral Capsule
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Subject is an ambulatory adult and between 18 and 55 years old (inclusive) at the screening visit * Subject is in good health and has no clinically significant findings on physical examination * Body mass index is \> 18 and \< 30 kg/m2 at the screening visit * Women of reprodu...

Countries:United States
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