Multiple Dose Study Of PF-05231023 In Obese Adult Subjects

Type 2 Diabetes Mellitus (T2DM) Clinical Trial

Official title:

A Phase 1, Placebo-Controlled, Randomized Trial To Assess The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Intravenous Doses Of PF-05231023 In Obese Adult Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01923389
• Other study ID #: B2901009
• Status: Terminated
• Phase: Phase 1
• First received: July 30, 2013
• Last updated: September 8, 2014
• Start date: September 2013
• Est. completion date: December 2013

Study information

• Verified date: September 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Recent (6 months) unstable concurrent disease.

• History of allergic disease or drug allergies.

• Any condition affecting food consumption or absorption.

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus (T2DM)

Intervention

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

Drug:
• 100 mg PF-05231023
100 mg IV infusion twice a week for 4 weeks

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Orlando	Florida
United States	Pfizer Investigational Site	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Primary	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)	Yes
Primary	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)	Yes
Primary	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)	Yes
Secondary	Number of Participants With Abnormal Clinical Laboratory Measurements	The total number of participants with laboratory test abnormalities without regard to baseline abnormality was assessed.	Days -7 up to the last follow-up (Day 68)	Yes
Secondary	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	No
Secondary	Maximum Plasma Concentration (Cmax) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)		Days 1 and 25	No
Secondary	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	No
Secondary	Average Concentration at Steady State (Cav) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)		Day 25	No
Secondary	Time for Cmax (Tmax)of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)		Day 25	No
Secondary	Clearance (CL)of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)		Day 25	No
Secondary	Terminal Elimination Half-life (t1/2)of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)		Day 25	No
Secondary	Observed Accumulation Ratio (Rac) for Cmax and AUCtau of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)		Day 25	No

External Links

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