Multiple Dose Study Of PF-05231023 In Obese Adult Subjects
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Interventions
- Drug: 100 mg PF-05231023Other: Placebo
- Registration Number
- NCT01923389
- Lead Sponsor
- Pfizer
- Brief Summary
This is a trial in obese subjects to study the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of PF-05231023.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 4
- 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.
- Recent (6 months) unstable concurrent disease.
- History of allergic disease or drug allergies.
- Any condition affecting food consumption or absorption.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 100 mg PF-05231023 100 mg PF-05231023 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events (AEs) Day -7 through the last follow-up (Day 68) 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.
Number of Participants With Vital Signs Data Met Criteria of Potential Clinical Concern Days -7 up to the last follow-up (Day 68) 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.
Number of Participants With Electrocardiogram (ECG) Data Met Criteria of Potential Clinical Concern Days -7 up to the last follow-up (Day 68) 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.
Number of Participants With Positive Anti-PF-05231023 Antibodies and Neutralizing Antibodies. Days 1 up to the last follow-up (Day 68) 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.
- Secondary Outcome Measures
Name Time Method Number of Participants With Abnormal Clinical Laboratory Measurements Days -7 up to the last follow-up (Day 68) The total number of participants with laboratory test abnormalities without regard to baseline abnormality was assessed.
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 Time for Cmax (Tmax)of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold) Day 25 Clearance (CL)of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold) Day 25 Terminal Elimination Half-life (t1/2)of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold) Day 25 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
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Orlando, Florida, United States