LivingGLP1
Study S001506

The Effect of Dulaglutide (LY2189265) on the Pharmacokinetics and Pharmacodynamics of Single Dose Warfarin in Healthy Subjects

ClinicalTrials.gov record

Registration

Registration
NCT01432938
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE1
Masking
NONE
Status
COMPLETED
Enrollment
28
Start
2011-09
Primary completion
2011-12
Lead sponsor
Eli Lilly and Company
Conditions
Diabetes Mellitus, Type 2
Interventions
BIOLOGICAL:dulaglutide; DRUG:Warfarin
Results posted
TRUE
Secondary identifiers
OTHER:H9X-MC-GBCS

Registered primary outcomes

  • Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of R-warfarin and S-warfarin [Predose (warfarin) and up to 144 hours postdose on Day 1 for Treatment 1 (warfarin alone) and on Day 3 for Treatment 2 (warfarin in combination with dulaglutide)]
  • Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of R-warfarin and S-warfarin [Predose (warfarin) and up to 144 hours postdose on Day 1 for Treatment 1 (warfarin alone) and on Day 3 for Treatment 2 (warfarin in combination with dulaglutide)]
  • Pharmacokinetics: Time to Maximum Concentration (Tmax) of R-warfarin and S-warfarin [Predose (warfarin) and up to 144 hours postdose on Day 1 for Treatment 1 (warfarin alone) and on Day 3 for Treatment 2 (warfarin in combination with dulaglutide)]

Linked records (1)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.
RecordTitleYearDesignIdentifiersLink basis
R0011520No Dose Adjustment is Recommended for Digoxin, Warfarin, Atorvastatin or a Combination Oral Contraceptive When Coadministered with Dulaglutide.
de la Peña A, Clinical pharmacokinetics
2017Other trialPMID 28357715DOIcites ClinicalTrials.gov:NCT01432938; registry reference DERIVED:28357715