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SNAC

Phase 1

Diabetes | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Dec 20, 2017

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 Enrollment41
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03010475A Trial Investigating the Effect of Oral Semaglutide on the Pharmacokinetics of Furosemide and Rosuvastatin in Healthy SubjectsPHASE1 COMPLETED 41Jan 5, 2017Aug 9, 2017Dec 20, 20171 United Kingdom
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Study Endpoints
Primary Endpoints
Area under the furosemide plasma concentration-time curve
day 1, day 7, day 54

Based on sampling between 0 and 12 hours

Area under the rosuvastatin plasma concentration-time curve
day 2, day 8, day 55

Based on sampling between 0 and 96 hours

Secondary Endpoints
Maximum observed furosemide plasma concentration
day 1, day 7, day 54
Maximum observed rosuvastatin plasma concentration
day 2, day 8, day 55
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Furosemide/Rosuvastatin/SNAC/SemaglutideEXPERIMENTAL -
Interventions
NameTypeDescription
FurosemideDRUGOral administration A total of three single doses.
RosuvastatinDRUGOral administration. A total of three single doses.
SNACDRUGOral administration. A total of five single doses.
SemaglutideDRUGOral administration. Once daily.
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial * Male or female, aged 18-65 years (both inclusive) at the time of ...

Countries:United Kingdom
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