A Study To Evaluate The Safety And Tolerability Of PF-03882845 In Patients With Type 2 Diabetic Nephropathy

Type 2 Diabetic Nephropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01488877
• Other study ID #: B0171011
• Status: Terminated
• Phase: Phase 1
• First received: December 6, 2011
• Last updated: September 24, 2013
• Start date: January 2012
• Est. completion date: July 2012

Study information

• Verified date: September 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetic Nephropathies
• Kidney Diseases
• Type 2 Diabetic Nephropathy

Intervention

Drug:
• PF-03882845
3 mg tablet once daily
• PF-03882845
up to 10 mg tablet once daily
• PF-03882845
up to 30 mg once daily
• Spironolactone
spironolactone 25 mg once daily

Other:
• placebo
placebo once daily

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Chula Vista	California
United States	Pfizer Investigational Site	DeLand	Florida
United States	Pfizer Investigational Site	Kalamazoo	Michigan
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Serum Potassium at Day 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.	Baseline, Day 7, 8	Yes
Primary	Change From Baseline in Serum Potassium at Day 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.	Baseline, Day 14, 15	Yes
Primary	Number of Participants With Confirmed and Severe Hyperkalemia	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.	Baseline up to Day 15	Yes
Secondary	Plasma Pharmacokinetic (PK) Parameters	PK parameters were to be evaluated at Day 1 and Day 14 (steady state). Maximum observed plasma concentration (Cmax), time to reach maximum observed plasma concentration (Tmax), area under the curve from time zero to end of dosing interval (AUCtau) were to be evaluated at both Day 1 and Day 14 (steady state). Minimum observed plasma trough concentration (Cmin), average plasma concentration (Cavg), apparent oral clearance (CL/F), apparent volume of distribution (Vz/F) were to be evaluated only at Day 14 (steady state). Observed accumulation ratio (Rac) was also planned to be analyzed.	0 (pre-dose), 2, 4, 6, 8, 10, 14, 24 hours post-dose on Day 1, 14	No
Secondary	Change From Baseline in Sitting Systolic and Diastolic Blood Pressure at Day 15	Systolic blood pressure (BP): BP when heart is contracting; maximum arterial pressure during contraction of left ventricle of heart. Diastolic blood pressure: BP when heart is relaxing; minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed; average of triplicate BP values collected pre-dose on Day 1 served as baseline. The same arm and same sized cuff (properly sized and calibrated) was used throughout the study, after participant sat for 5 minutes for the first measurement and 2 minutes for second and third measurements.	Day 1 (Baseline), 15	Yes
Secondary	Change From Baseline in Sitting Pulse Rate at Day 15	Sitting pulse rate was measured in the brachial/radial artery for at least 30 seconds. A total of 3 measurements were performed; average of triplicate pulse rate values collected pre-dose on Day 1 served as baseline.	Day 1 (Baseline), 15	Yes

External Links

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