Clinical trial NCT00926263: A Pharmacokinetic And QT Study Of CP-751,871 In Healthy Subjects
Official title: A Phase 1, Open Label Study To Evaluate The Pharmacokinetics, Pharmacodynamics, And Effect On QT/QTc Interval For CP-751,871 Following Single Intravenous Administration To Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Pharmacokinetics
Pharmacodynamics
QTc interval prolongation
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-06-23
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study is primarily to evaluate the single dose pharmacokinetics of CP-751,871 and its effect on QT interval prolongation.

Detailed description: This study was terminated on October 30th, 2009. While the study was terminated due to adverse events and altered benefit/risk ratio in healthy subjects, the findings in healthy volunteers are not considered to alter the benefit/risk evaluation of figitumumab in cancer patients. No changes due to the termination of this study are anticipated in the conduct of the ongoing cancer patient studies with figitumumab at this time.

Eligibility criteria: Inclusion Criteria:

* Healthy male subjects and/or healthy female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* 12-lead ECG demonstrating QTc \>450 msec at screening or other clinically significant abnormalities at screening.
* History or family history of risk factors for QTc interval prolongation or torsades de pointes (eg, organic heart disease, congestive heart failure, hypokalemia, hypomagnesemia, congenital long QT syndrome, myocardial ischemia or infarction); family history of sudden death.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85
measure: Area Under the Curve From Time Zero to the Last Time Point With Quantifiable Concentration (AUClast)
timeFrame: Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85
measure: Plasma Clearance (CL)
timeFrame: Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85
measure: Apparent Volume of Distribution (Vz)
timeFrame: Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85
measure: Plasma Decay Half-Life (t1/2)
timeFrame: Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85
measure: QTc Using Fridericia's Correction Method (QTcF) After Receiving CP-751,871 at the 20/20 mg/kg Dose Level
timeFrame: Day 1 at 1 and 24 hours post-dose, Day 7, 28
Secondary outcomes:
measure: QTcF After Receiving Moxifloxacin at the Historical Moxifloxacin Median Tmax of 3 Hours
timeFrame: baseline, 3 hours postdose
measure: Serum Concentration of Insulin-like Growth Factor 1 (IGF-1)
timeFrame: Day 1 pre-dose (Baseline), 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85
measure: Serum Concentration of Free Insulin-like Growth Factor 1 (IGF-1)
timeFrame: Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85
measure: Serum Concentration of Insulin-like Growth Factor 2 (IGF-2)
timeFrame: Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85
measure: Serum Concentration of Insulin-like Growth Factor Binding Protein 3 (IGFBP-3)
timeFrame: Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85
measure: Serum Concentration of Insulin
timeFrame: Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85
measure: Serum Concentration of Fasting Glucose
timeFrame: Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85
measure: Anti-drug Antibodies (ADA) Against CP-751,871 in Serum Samples
timeFrame: Day 1 pre-dose, Day 15, 29, 57, 85
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: