A 2-week, Phase 1b, Randomized, Double-Blind, Placebo- Controlled, Multi-Dose, Dose-Escalating Study With PF-03882845 And One Dose Of Spironolactone To Evaluate Safety, Tolerability, Pharmacokinetics And Pharmacodynamics In Subjects With Type 2 Diabetes Mellitus And Albuminuria
Overview
- Phase
- Phase 1
- Intervention
- PF-03882845
- Conditions
- Type 2 Diabetic Nephropathy
- Sponsor
- Pfizer
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Serum Potassium at Day 8
- Status
- Terminated
- Last Updated
- 12 years ago
Overview
Brief Summary
PF-03882845 is a compound proposed for treatment of type 2 diabetic nephropathy. The primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of multiple doses of PF-03882845 in this population.
Detailed Description
This study was terminated on 12-Sep-2012; this decision was made due to poor recruitment and overall business strategy. The study was not terminated for safety reasons nor for lack of efficacy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males and/or Females between 18-65 years, inclusive.
- •Body mass index of 18.5 to 45.4 kg/m2 at screening, inclusive. body weight equals or greater than 110 lb.
- •Have type 2 diabetes mellitus.
- •On stable dose of anti-diabetic and anti-hypertensive medication prior to screening.
Exclusion Criteria
- •Recent evidence or medical history of unstable concurrent disease.
- •Cardiovascular event within 3 months prior to screening.
- •History of renal transplant.
- •History of hospitalization for acute kidney injury or acute kidney dialysis within 6 months prior to screening.
Arms & Interventions
PF03882845
Intervention: PF-03882845
Spironolactone
25 mg once daily
Intervention: Spironolactone
Placebo
Placebo once daily
Intervention: placebo
Outcomes
Primary Outcomes
Change From Baseline in Serum Potassium at Day 8
Time Frame: Baseline, Day 7, 8
Baseline value calculated as the average of -24 hours (pre-dose) measurement on Day -1 and 0 hours (immediately pre-dose) measurement on Day 1. Day 8 value calculated was average of 0 hours (immediately pre-dose) measurements on Day 7 and 8. Change from baseline values were presented under time point of Day 8.
Change From Baseline in Serum Potassium at Day 15
Time Frame: Baseline, Day 14, 15
Baseline value calculated as the average of -24 hours (pre-dose) measurement on Day -1 and 0 hours (immediately pre-dose) measurement on Day 1. Day 15 value calculated was average of 0 hours (immediately pre-dose) measurement on Day 14 and measurement obtained prior to discharge on Day 15. Change from baseline values were presented under time point of Day 15.
Number of Participants With Confirmed and Severe Hyperkalemia
Time Frame: Baseline up to Day 15
Hyperkalemia refers to the condition in which the concentration of the electrolyte potassium in the blood is elevated. Confirmed hyperkalemia is defined as serum potassium level greater than (\>) upper limit of normal (ULN) of 5.4 mEq/L. Severe hyperkalemia is defined as serum potassium level \>= 6.0 mEq/L. Number of participants with at least 1 confirmed or severe hyperkalemia is reported.
Secondary Outcomes
- Plasma Pharmacokinetic (PK) Parameters(0 (pre-dose), 2, 4, 6, 8, 10, 14, 24 hours post-dose on Day 1, 14)
- Change From Baseline in Sitting Systolic and Diastolic Blood Pressure at Day 15(Day 1 (Baseline), 15)
- Change From Baseline in Sitting Pulse Rate at Day 15(Day 1 (Baseline), 15)