Recent Updates
Recently added Catalysts

Bumetanide

Phase 1

Type 2 Diabetes Mellitus | Small molecule | Metabolic |AstraZeneca PLC|Last Updated: Oct 17, 2016

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment42
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00930865Study to Evaluate the Potential Pharmacokinetic Interaction and Pharmacodynamic Effects on Renal Parameters of Bumetanide (1mg) and Dapagliflozin (10 mg) When Co-administered in Healthy SubjectsPHASE1 COMPLETED 42 — — Jul 1, 2009Sep 1, 2009Oct 17, 20161 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Exposure to the investigational drug will be measured to compare with and without the co-administration of other drugs
24 hours post-dose on Day 8 and 15
Secondary Endpoints
To assess the safety and tolerability of bumetanide and dapagliflozin following multiple oral doses of 1 mg bumetanide and 10 mg dapagliflozin, administered together, either simultaneously or after adaptation to either agent alone, in healthy subjects
during 14 days of dosing
Explore potential pharmacodynamic (serum/urine electrolytes) effects of bumetanide + dapagliflozin following multiple doses of 1 mg bumetanide + 10 mg dapagliflozin, administered together, either simultaneously or after adaptation to either agent alone
during 14 days of dosing
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BumetanideACTIVE_COMPARATOR -
DapagliflozinACTIVE_COMPARATOR -
Bumetanide + DapagliflozinACTIVE_COMPARATOR -
Interventions
NameTypeDescription
BumetanideDRUGTablets, Oral, 1 mg, Single Dose, 7 Days
DapagliflozinDRUGTablets, Oral, 10 mg. Single Dose, 7 Days
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations * Body Mass Index (BMI) of 18 to 32 kg/m², inclusive. BMI = weight (kg)/ \[height (m)\]² * Women of childbea...

Countries:United States
Unlock Eligibility Criteria