Multiple Dose Study Of PF-05231023 In Obese Adult Subjects

NCT01923389 | Terminated Phase 1 Results

• 1 other identifier: B2901009
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

Brief Summary

This is a trial in obese subjects to study the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of PF-05231023.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Keywords

T2DM; obesity; safety; multiple dose; intravenous

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Adverse Events (AEs)

  An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were also reported for the 7-day pre-randomization period.

  Day -7 through the last follow-up (Day 68)

• Number of Participants With Vital Signs Data Met Criteria of Potential Clinical Concern

  Vital signs included supine systolic blood pressure, diastolic blood pressure and pulse rate. Vital signs criteria of potential clinical concern were 1), blood pressure: systolic greater than or equal to (\>=)30 millimeters of mercury (mm Hg) change from baseline in the same posture or systolic less than (\<)90 mm Hg; diastolic \>=20 mm Hg change from baseline in the same posture or diastolic \<50 mm Hg; 2), Pulse rate: supine/Sitting: \<40 or greater than (\>) 120 beats per minute (bpm); Standing: \<40 or \>140 bpm.

  Days -7 up to the last follow-up (Day 68)

• Number of Participants With Electrocardiogram (ECG) Data Met Criteria of Potential Clinical Concern

  ECG criteria of potential clinical concern were 1), PR interval:\>=300 msec, \>=25% increase when baseline \>200 msec, or \>=50% increase when baseline \<=200 msec; 2), QRS interval:\>=140 msec, or \>=50% increase from baseline; 3), QT interval corrected for heart rate (QTc)/QTc interval using Fridericia's formula (QTcF):\>=500 msec, QTcF interval: absolute value \>=450 - \<480 msec(borderline), \>=480 msec (prolonged), absolute change 30 - \<60 msec (borderline) or \>=60 msec (prolonged). 12-lead ECG (triplicate) was performed on Day 0 and 12-lead ECG (singlet) was performed at other times.

  Days -7 up to the last follow-up (Day 68)

• Number of Participants With Positive Anti-PF-05231023 Antibodies and Neutralizing Antibodies.

  Anti-PF-05231023 antibodies were analyzed using a tiered testing strategy of screen, confirm, and titer characterization. Positive was defined as titer value \>=6.23 and negative was defined as titer value \<6.23. Samples tested positive were also to be analyzed in a neutralization assay to determine whether or not they were neutralizing or non-neutralizing.

  Days 1 up to the last follow-up (Day 68)

Secondary Outcomes (9)

• Number of Participants With Abnormal Clinical Laboratory Measurements

  Days -7 up to the last follow-up (Day 68)

• Area Under the Concentration Versus Time Curve From Time 0 to Tau, the Dosing Interval (AUCtau) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)

  Days 1 and 25

• Maximum Plasma Concentration (Cmax) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)

  Days 1 and 25

• Lowest Concentration Observed During Dosing Interval (Cmin) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)

  Day 25

• Average Concentration at Steady State (Cav) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)

  Day 25

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Other: Placebo

100 mg PF-05231023

EXPERIMENTAL

Drug: 100 mg PF-05231023

Interventions

Placebo OTHER

0.9% w/v sodium chloride injection, United States Pharmacopeia (USP), twice a week for 4 weeks.

Placebo

100 mg PF-05231023 DRUG

100 mg IV infusion twice a week for 4 weeks

100 mg PF-05231023

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects of non-childbearing potential between the ages of 21 and 70.
• Subjects with a BMI of 30 to 45.4 kg/m2 and total body weight \>110 lbs.

You may not qualify if:

• Recent (6 months) unstable concurrent disease.
• History of allergic disease or drug allergies.
• Any condition affecting food consumption or absorption.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

Pfizer Investigational Site

Orlando, Florida, 32803, United States

Location

Pfizer Investigational Site

Orlando, Florida, 32804, United States

Location

Related Links

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

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity

Interventions

PF-05231023

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• 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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2013
• First Posted: August 15, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 17, 2014
• Results First Posted: September 17, 2014

Record last verified: 2014-09

Locations

US (2)