A Pharmacokinetic And QT Study Of CP-751,871 In Healthy Subjects

NCT00926263 | Terminated Phase 1 Results

• 1 other identifier: A4021037
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Keywords

Pharmacokinetics; Pharmacodynamics; QTc interval prolongation

Outcome Measures

Primary Outcomes (6)

• Maximum Observed Plasma Concentration (Cmax)

  Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85

• Area Under the Curve From Time Zero to the Last Time Point With Quantifiable Concentration (AUClast)

  Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

  Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85

• Plasma Clearance (CL)

  Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.

  Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85

• Apparent Volume of Distribution (Vz)

  Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.

  Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85

• Plasma Decay Half-Life (t1/2)

  Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85

• QTc Using Fridericia's Correction Method (QTcF) After Receiving CP-751,871 at the 20/20 mg/kg Dose Level

  QTcF is the time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole, corrected for heart rate using Fridericia's correction

  Day 1 at 1 and 24 hours post-dose, Day 7, 28

Secondary Outcomes (8)

• QTcF After Receiving Moxifloxacin at the Historical Moxifloxacin Median Tmax of 3 Hours

  baseline, 3 hours postdose

• Serum Concentration of Insulin-like Growth Factor 1 (IGF-1)

  Day 1 pre-dose (Baseline), 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85

• Serum Concentration of Free Insulin-like Growth Factor 1 (IGF-1)

  Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85

• Serum Concentration of Insulin-like Growth Factor 2 (IGF-2)

  Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85

• Serum Concentration of Insulin-like Growth Factor Binding Protein 3 (IGFBP-3)

  Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85

Study Arms (3)

10 mg/kg cohort

EXPERIMENTAL

Biological: CP-751,871

20 mg/kg cohort

EXPERIMENTAL

Biological: CP-751,871

20/20 mg/kg cohort

EXPERIMENTAL

Biological: CP-751,871, moxifloxacin, saline

Interventions

CP-751,871 BIOLOGICAL

single dose, 1-hr IV infusion

10 mg/kg cohort

CP-751,871, moxifloxacin, saline BIOLOGICAL

Two doses at 20 mg/kg each on two consecutive days, each administered via 1-hr IV infusion

20/20 mg/kg cohort

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511-5473, United States

Location

Related Links

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

MeSH Terms

Interventions

figitumumab; Moxifloxacin; Sodium Chloride

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

This study was terminated prior to enrollment of participants into Cohort 3 (2 doses of 20 mg/kg on consecutive days). Therefore, endpoints relating to that cohort were not assessed.

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: Yes
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2009
• First Posted: June 23, 2009
• Study Start: July 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: May 7, 2013
• Results First Posted: May 7, 2013

Record last verified: 2013-03

Locations

US (1)