Clinical trial NCT01923389: Multiple Dose Study Of PF-05231023 In Obese Adult Subjects
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus (T2DM)
Keywords: T2DM
obesity
safety
multiple dose
intravenous
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-08-15
Enrollment: 4
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Day -7 through the last follow-up (Day 68)
measure: Number of Participants With Vital Signs Data Met Criteria of Potential Clinical Concern
timeFrame: Days -7 up to the last follow-up (Day 68)
measure: Number of Participants With Electrocardiogram (ECG) Data Met Criteria of Potential Clinical Concern
timeFrame: Days -7 up to the last follow-up (Day 68)
measure: Number of Participants With Positive Anti-PF-05231023 Antibodies and Neutralizing Antibodies.
timeFrame: Days 1 up to the last follow-up (Day 68)
Secondary outcomes:
measure: Number of Participants With Abnormal Clinical Laboratory Measurements
timeFrame: Days -7 up to the last follow-up (Day 68)
measure: 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)
timeFrame: Days 1 and 25
measure: Maximum Plasma Concentration (Cmax) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)
timeFrame: Days 1 and 25
measure: Lowest Concentration Observed During Dosing Interval (Cmin) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)
timeFrame: Day 25
measure: Average Concentration at Steady State (Cav) of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)
timeFrame: Day 25
measure: Time for Cmax (Tmax)of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)
timeFrame: Day 25
measure: Clearance (CL)of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)
timeFrame: Day 25
measure: Terminal Elimination Half-life (t1/2)of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)
timeFrame: Day 25
measure: Observed Accumulation Ratio (Rac) for Cmax and AUCtau of PF-05231023 (C-terminus and N-terminus PF-05231023 and Total CVX-2000 Antibody Scaffold)
timeFrame: Day 25
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: