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SNAC

Phase 1

Diabetes | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Jan 12, 2018

Success Probability

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment41

FDA Designations

No designations recorded

Clinical trial landscape

SNAC · 2 trials · 2 indications

Phase 1 2
NCT03010475A Trial Investigating the Effect of Oral Semaglutide on the Pharmacokinetics of Furosemide and Rosuvastatin in Healthy SubjectsDiabetes
COMPLETED41 Analytics
NCT02911870A Thorough QTc Trial Evaluating the Effect of SNAC on Cardiac Repolarisation in Healthy Male Subjects.Healthy
COMPLETED84 Analytics
PHASE1COMPLETED
A Trial Investigating the Effect of Oral Semaglutide on the Pharmacokinetics of Furosemide and Rosuvastatin in Healthy Subjects
DiabetesUnlock trial analytics
PHASE1COMPLETED
A Thorough QTc Trial Evaluating the Effect of SNAC on Cardiac Repolarisation in Healthy Male Subjects.
HealthyUnlock trial analytics

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

Number of treatment emergent adverse events
From dosing (day 1) to follow-up (days 8-11)

PART A

The co-primary endpoints are Fridericia heart rate corrected QT interval (QTcF)
At 10, 20, 30, 40, 50 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 8, and 12 hours

PART B

Secondary Endpoints

Maximum observed furosemide plasma concentration
day 1, day 7, day 54
Maximum observed rosuvastatin plasma concentration
day 2, day 8, day 55
Maximum observed SNAC plasma concentration
From 0 to 12 hours
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Furosemide/Rosuvastatin/SNAC/SemaglutideEXPERIMENTAL -
Part A, SNACEXPERIMENTALSingle dose of 1.2mg, 2.4mg or 3.6mg increasing for each cohort of trial participants.
Part A, placeboPLACEBO_COMPARATORSingle dose at corresponding dose levels.
Part B, SNAC, Placebo, MoxifloxacinEXPERIMENTALSubjects will receive 4 different treatments in random order. SNAC dose between 1.2-3.6 mg, Placebo in two different periods, moxifloxacin 400mg.

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.
PlaceboDRUGOral administration
MoxifloxacinDRUGOral administration
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Eligibility Criteria

Age Range18 Years to 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 KingdomGermany
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Competitive Landscape -Diabetes Complications 6 trials (matched to "Diabetes")

Frequently asked questions about SNAC

What is SNAC used for?

SNAC is an investigational small molecule being developed by Novo Nordisk A/S for metabolic conditions, studied in healthy volunteers and in diabetes. It is in Phase 1 clinical development and is not approved by the FDA. SNAC is being evaluated for its effects on cardiac repolarization and on the pharmacokinetics of other drugs.

Who makes SNAC?

SNAC is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO. The company is conducting Phase 1 clinical trials to evaluate the safety and pharmacological effects of SNAC in healthy subjects and in individuals with diabetes.

What phase is SNAC in?

SNAC is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. Clinical trials are ongoing or completed to assess its safety and how it interacts with other medications, but it is not yet available for clinical use.

What clinical trials is SNAC in?

SNAC has been studied in two completed Phase 1 trials. NCT02911870 evaluated the effect of SNAC on cardiac repolarization in 84 healthy male subjects in Germany. NCT03010475 investigated the effect of oral semaglutide on the pharmacokinetics of furosemide and rosuvastatin in 41 healthy subjects in the United Kingdom.

Is SNAC the same as oral semaglutide?

SNAC is not the same as oral semaglutide. SNAC is a separate small molecule being studied for its own effects. In one clinical trial, NCT03010475, the effect of oral semaglutide on the pharmacokinetics of other drugs was investigated, and SNAC was part of that study context, but they are distinct compounds.