LivingGLP1
Study S003097

An Open-label, Single-sequence, Crossover Trial Investigating the Influence of NNC9204-1177 on Pharmacokinetics of Index Substrates for Cytochrome P450 Enzymes

ClinicalTrials.gov record

Registration

Registration
NCT04059367
Study type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Phase
PHASE1
Masking
NONE
Status
COMPLETED
Enrollment
45
Start
2019-08-15
Primary completion
2020-01-02
Lead sponsor
Novo Nordisk A/S
Conditions
Healthy Volunteers; Overweight; Obesity
Interventions
DRUG:NNC9204-1177; DRUG:Cocktail of 5 already approved drugs
Results posted
FALSE
Individual participant data sharing
YES
Secondary identifiers
OTHER:U1111-1232-7100 Trial

Registered primary outcomes

  • Area under the plasma concentration-time curve extrapolated to infinity of the caffeine [From 0 to 24 hours after a single dose of caffeine without NNC9204-1177 exposure (administered on Visit 2, Day 1) and at NNC9204-1177 steady state (administered on Visit 12, Day 78)]
  • Area under the plasma concentration-time curve extrapolated to infinity of the omeprazole [From 0 to 8 hours after a single dose of omeprazole without NNC9204-1177 exposure (administered on Visit 2, Day 1) and at NNC9204-1177 steady state (administered on Visit 12, Day 78)]
  • Area under the plasma concentration-time curve extrapolated to infinity of the midazolam [From 0 to 12 hours after a single dose of midazolam without NNC9204-1177 exposure (administered on Visit 2, Day 1) and at NNC9204-1177 steady state (administered on Visit 12, Day 78)]
  • Area under the plasma concentration-time curve extrapolated to infinity of the s-warfarin [From 0 to 168 hours after a single dose of warfarin without NNC9204-1177 exposure (administered on Visit 2, Day 1) and at NNC9204-1177 steady state (administered on Visit 12, Day 78)]
  • Area under the plasma concentration-time curve extrapolated to infinity of the dextromethorphan [From 0 to 72 hours after a single dose of dextromethorphan without NNC9204-1177 exposure (administered on Visit 2, Day 1) and at NNC9204-1177 steady state (administered on Visit 12, Day 78)]

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