Study To Evaluate The Effect Of Renal Impairment On The Pharmacokinetics Of PF-04991532

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of a single oral dose of PF-04991532 in subjects with renal impairment.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

STUDY OF PF-06882961 IN PARTICIPANTS WITH TYPE 2 DIABETES MELLITUS WITH VARYING DEGREES OF RENAL IMPAIRMENT AND PARTICIPANTS WITHOUT RENAL IMPAIRMENT

NCT04616027

Diabetes Mellitus, Type 2 Renal Impairment Healthy

COMPLETED PHASE1

Study to Assess PK, Safety and Tolerability in Patients With DM and CKD

NCT03795389

Chronic Kidney Disease Chronic Kidney Disease, Stage 3 (Moderate) Chronic Kidney Disease, Stage 4 (Severe) +1 more

COMPLETED PHASE1

Effect of Renal Impairment on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Ertugliflozin in Participants With Type 2 Diabetes Mellitus (MK-8835-009)

NCT01948986

Renal Impairment Type 2 Diabetes Mellitus

COMPLETED PHASE1

To Assess the Pharmacokinetics of AZD1656 and Its Metabolite in Type 2 Diabetes Mellitus Patients

NCT01069926

Glucose Lowering

COMPLETED PHASE1

A Study to Look at the Effect MEDI0382 Has on Blood Sugar in People With Type 2 Diabetes and Kidney Problems and Also to Check That MEDI0382 is Well Tolerated

NCT03550378

Type II Diabetes Mellitus Renal Insufficiency

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes Mellitus Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

healthy controls

healthy subjects (creatinine clearance \> 90 mL/min)

Group Type EXPERIMENTAL

PF-04991532

Intervention Type DRUG

single dose 300-mg

ESRD / severe renal insufficiency

Severe (creatinine clearance 15 to 29 mL/min) OR ESRD (creatinine clearnace \<15 mL/min OR requiring dialysis)

Group Type EXPERIMENTAL

PF-04991532

Intervention Type DRUG

single dose 300-mg

Moderate renal impairment

Moderate (creatinine clearance = 30 to 59 mL/min)

Group Type EXPERIMENTAL

PF-04991532

Intervention Type DRUG

single dose 300-mg

Mild renal impairment

Mild (creatinine clearance = 60 to 89 mL/min)

Group Type EXPERIMENTAL

PF-04991532

Intervention Type DRUG

single dose 300-mg

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PF-04991532

single dose 300-mg

Intervention Type DRUG

PF-04991532

single dose 300-mg

Intervention Type DRUG

PF-04991532

single dose 300-mg

Intervention Type DRUG

PF-04991532

single dose 300-mg

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Stable renal function defined as \<20% difference between two measurements of serum creatinine obtained on two occasions separated by at least 72 hours to 14 days; the second determination must be obtained within the 28-day period prior to the start of study medication administration. CrCl value at Screening (average of two values obtained within two weeks apart before dosing) will be used for study enrollment.
* Body Mass Index (BMI) of 17.5 to 40 kg/m2; and a total body weight \>50 kg (110 lbs).
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria

* Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception as outlined in this protocol from at least 14 days prior to the first dose of study medication.
* Subjects with recent (within the last 6 months) history of myocardial infarction, unstable angina, coronary revascularization, stroke or transient ischemic attack (TIA).
* Subjects with severe heart failure (New York Heart Association Functional Class IV) at Screening.
* Subjects with acute renal disease.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes