Single-Dose And Multiple-Dose Safety And Tolerability Study Of PF-04856883 In Type 2 Diabetic Adult Females

NCT01301456 | Completed Phase 1 Results

• 1 other identifier: B1111002
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 7

Brief Summary

The primary objective of this study is to evaluate the safety and tolerability of PF-04856883 (CVX-096) in adult female subjects with Type 2 diabetes mellitus on high dose of metformin.

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Keywords

Phase 1; Type 2 Diabetes; CVX-096

Outcome Measures

Primary Outcomes (5)

• Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)

  An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose (Day 50) that were absent before treatment or that worsened relative to pretreatment state.

  Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50

• Number of Participants With Clinically Significant Physical Examination Findings

  Physical examination included examination of general appearance, head, ears, eyes (including fundoscopy), nose, mouth, throat, neck (including thyroid), skin, breast (optional), cardiac, respiratory, gastrointestinal, musculoskeletal and neurological systems.

  Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50

• Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG)

  ECG parameters included pulse rate (PR) interval, QRS interval, corrected QT interval using Bazett's formula (QTcB) and corrected QT interval using Fridericia's formula (QTcF). ECG criteria of clinically significant concern were 1) PR interval: greater than equal to (\>=) 25 percent (%) increase when baseline greater than (\>)200 milliseconds (msec); or increase \>=50% when baseline less than or equal to (\<=200) msec; 2) QRS interval: \>=25% increase when baseline \>100 msec; \>=50% increase when baseline \<= 100 msec; 3) QTCF interval: QTc interval using Fridericia's formula (QTcF interval) and Bazett's formula (QTcB interval): absolute value 450 - \<480 msec, 480 - \<500 msec \>=500; absolute change 30 - \<60, \>=60 msec. The number of participants with potentially clinically significant ECG findings at any visit were reported. IFB = increase from baseline.

  Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50

• Number of Participants With Vital Sign Abnormalities

  Criteria for vital signs abnormalities: sitting/supine systolic pulse rate less than (\<) 40 beats per minute (bpm) or greater than (\>) 120 bpm, standing/supine systolic pulse \< 40 bpm or \> 140 bpm, systolic blood pressure of \>=30 millimeters of mercury (mmHg) change from baseline and systolic blood pressure \<90 mmHg, diastolic blood pressure \>=20 mmHg change from baseline and diastolic blood pressure \<50 mm Hg.

  Stage 1: Baseline up to Day 29; Stage 2 : Baseline up to Day 50

• Number of Participants With Clinically Significant Abnormalities in Laboratory Measurements

  Following parameters were analyzed for laboratory examination: Hematology: hemoglobin, hematocrit, red blood cell (RBC) \<0.8\*lower limit of the reference range (LLRR); leukocytes \<0.6\*LLRR or \>1.5\*ULRR; platelet count \<0.5\*LLRR or \>1.75\*upper limit of the reference range (ULRR); total neutrophils (absolute \[abs\]), lymphocytes (abs) \<0.8\*LLRR or \>1.2\*ULRR; eosinophils (abs), basophils (abs), monocytes (abs) \>1.2\*ULRR; chemistry (total bilirubin, direct bilirubin, indirect bilirubin \>1.5\*ULRR; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase \>3\*ULRR, albumin, total protein \<0.8\*LLRR or \>1.2\*ULRR; blood urea nitrogen (BUN), creatinine \>1.3\*ULRR; glucose (fasting) \<0.6\*LLRR or \>1.5\*ULRR; uric acid \>1.2\* ULRR; sodium \<0.95\*LLRR or \>1.05\*ULRR; potassium, chloride, bicarbonate, calcium \<0.9\*LLRR or \>1.1\*ULRR. Urinalysis: Urine white blood cell (WBC), Urine RBC =\>20/ high-power field (HPF).

  Stage 1: Baseline up to Day 29; Stage 2: Baseline up to Day 50

Secondary Outcomes (28)

• Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 1

  predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1

• Maximum Observed Plasma Concentration (Cmax) of PF-04856883: Stage 2

  predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336 hours postdose on Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22

• Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 1

  predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1

• Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883: Stage 2

  predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336 hours postdose on Day 1; predose (0 hour), 1, 2, 6, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 22

• Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) of PF-04856883: Stage 1

  predose (0 hour), 1, 6, 12, 24, 48, 72, 120, 168, 336, 504, 672 hours postdose on Day 1

Study Arms (13)

Treatment Arm 1 (Stage 1A)

PLACEBO COMPARATOR

Biological: Placebo

Treatment Arm 2 (Stage 1A)

EXPERIMENTAL

Biological: PF-04856883

Treatment Arm 3 (Stage 1A)

EXPERIMENTAL

Biological: PF-04856883

Treatment Arm 4 (Stage 1A)

EXPERIMENTAL

Biological: PF-04856883

Treatment Arm 5 (Stage 1B)

PLACEBO COMPARATOR

Biological: Placebo

Treatment Arm 6 (Stage 1B)

EXPERIMENTAL

Biological: PF-04856883

Treatment Arm 7 (Stage 1B)

EXPERIMENTAL

Biological: PF-04856883

Treatment Arm 8 (Stage 1B)

EXPERIMENTAL

Biological: PF-04856883

Treatment Arm 9 (Stage 2)

PLACEBO COMPARATOR

Biological: Placebo

Treatment Arm 10 (Stage 2)

EXPERIMENTAL

Biological: PF-04856883

Treatment Arm 11 (Stage 2)

EXPERIMENTAL

Biological: PF-04856883

Treatment Arm 12 (Stage 2)

EXPERIMENTAL

Biological: PF-04856883

Treatment Arm 13 (Stage 2)

EXPERIMENTAL

Biological: PF-04856883

Interventions

Placebo BIOLOGICAL

Single subcutaneous injection of placebo

Treatment Arm 1 (Stage 1A)

PF-04856883 BIOLOGICAL

Single subcutaneous injection of PF-04856883

Also known as: CVX-096

Treatment Arm 2 (Stage 1A)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of Type 2 diabetes and currently being treated with high dose metformin
• BMI between 22.0 and 40.0 kg/m2
• HbA1c between 7.0-10.0%
• Fasting C-peptide \>1.21 ng/mL

You may not qualify if:

• History of clinically significant chronic conditions other than Type 2 diabetes not well controlled by either diet or medications
• Treatment with anti-diabetic therapies other than metformin
• History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody
• Males or women of childbearing potential

Sponsors & Collaborators

• Pfizer: lead

Study Sites (7)

Profil Institute for Clinical Research, Inc.

Chula Vista, California, 91911, United States

Location

Elite Research Institute

Miami, Florida, 33169, United States

Location

Comprehensive Phase One (A Division of Comprehensive NeuroScience, Inc.)

Miramar, Florida, 33025, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30308, United States

Location

ICON Clinical Pharmacology, LLC

Omaha, Nebraska, 68154, United States

Location

CRI Worldwide, LLC

Philadelphia, Pennsylvania, 19139, United States

Location

Healthcare Discoveries LLC d/b/a ICON Development Solutions

San Antonio, Texas, 78209, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2011
• First Posted: February 23, 2011
• Study Start: March 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: April 1, 2012
• Last Updated: February 9, 2018
• Results First Posted: February 9, 2018

Record last verified: 2017-07

Locations

US (7)