Healthy VolunteersPhase 1NCT00926263

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

A Phase 1 study testing CP-751,871 and CP-751,871, moxifloxacin, saline in people with Healthy Volunteers, run by Pfizer at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: CP-751,871 and CP-751,871, moxifloxacin, saline
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteUnited States
Study dates: Jul 2009to May 2010
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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).

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Pfizer Investigational Site
New Haven, Connecticut, 06511-5473

Other trials in United States

About this study

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

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

Read the 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.

Conditions: Healthy Volunteers
Being tested: CP-751,871, CP-751,871, moxifloxacin, saline
Keywords: Pharmacokinetics, Pharmacodynamics, QTc interval prolongation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CP-751,871Biological
single dose, 1-hr IV infusion
CP-751,871Biological
single dose, 1-hr IV infusion
CP-751,871, moxifloxacin, salineBiological
Two doses at 20 mg/kg each on two consecutive days, each administered via 1-hr IV infusion

Study groups in NCT00926263
Study group	Role	What they receive
10 mg/kg cohort	Experimental	Not described Receives: Biological: CP-751,871
20 mg/kg cohort	Experimental	Not described Receives: Biological: CP-751,871
20/20 mg/kg cohort	Experimental	Not described Receives: Biological: CP-751,871, moxifloxacin, saline

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Plasma Concentration (Cmax)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: baseline, 3 hours postdose
Serum Concentration of Insulin-like Growth Factor 1 (IGF-1)
IGF-1 is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline.
Measured: 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)
IGF-1 is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline.
Measured: 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)
IGF-2 is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline.
Measured: 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)
IGFBP-3 is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline.
Measured: 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
Insulin is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline.
Measured: 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 Fasting Glucose
Glucose is one of the IGF-axis related biomarkers. Part of the secondary objectives of the study was to explore the relationships of plasma CP-751,871 concentrations to such biomarkers. Cmax is the mean ± standard deviation (SD) concentration observed at the time of maximal change from baseline.
Measured: Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85
Anti-drug Antibodies (ADA) Against CP-751,871 in Serum Samples
Number of participants who tested positive for ADA
Measured: Day 1 pre-dose, Day 15, 29, 57, 85

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2009May 2010

First posted23 Jun 2009 (estimated)
Study startJul 2009
Primary completionMay 2010
Study completionMay 2010

Why it stopped: See termination reason in detailed description.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00926263
Sponsor's protocol ID: A4021037
Status last verified: Mar 2013
First submitted: 21 Jun 2009
Last updated: 7 May 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00926263
Acronym / sponsor ID: A4021037
Conditions: Healthy Volunteers
Keywords: Pharmacokinetics, Pharmacodynamics, QTc interval prolongation
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: See termination reason in detailed description.
Enrolment: 28 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jul 2009
Primary completion: May 2010 (actual)
Study completion: May 2010 (actual)
First posted: 23 Jun 2009 (estimated)
Results: Posted 7 May 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
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

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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).

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CP-751,871single dose, 1-hr IV infusion	Biological	10 mg/kg cohort
CP-751,871single dose, 1-hr IV infusion	Biological	20 mg/kg cohort
CP-751,871, moxifloxacin, salineTwo doses at 20 mg/kg each on two consecutive days, each administered via 1-hr IV infusion	Biological	20/20 mg/kg cohort

Primary outcome

Maximum Observed Plasma Concentration (Cmax)
Time frame: 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)
Time frame: 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 plasma concentration time-curve from zero to the last measured concentration (AUClast)
Plasma Clearance (CL)
Time frame: Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Apparent Volume of Distribution (Vz)
Time frame: Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85
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.
Plasma Decay Half-Life (t1/2)
Time frame: 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 is the time measured for the plasma concentration to decrease by one half.
QTc Using Fridericia's Correction Method (QTcF) After Receiving CP-751,871 at the 20/20 mg/kg Dose Level
Time frame: Day 1 at 1 and 24 hours post-dose, Day 7, 28
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

8 secondary outcomes

QTcF After Receiving Moxifloxacin at the Historical Moxifloxacin Median Tmax of 3 Hours
Time frame: baseline, 3 hours postdose
Serum Concentration of Insulin-like Growth Factor 1 (IGF-1)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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 Fasting Glucose
Time frame: Day 1 pre-dose, 1 hour post dose, Day 2 (24 hours post-dose), Day 8, 15, 22, 29, 43, 57, 71, 85
Anti-drug Antibodies (ADA) Against CP-751,871 in Serum Samples
Time frame: Day 1 pre-dose, Day 15, 29, 57, 85

Results and safety

Results posted to the registry on 7 May 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CP-751,871 10 mg/kg	16	16
CP-751,871 20 mg/kg	12	12

Primary outcome: Maximum Observed Plasma Concentration (Cmax)

Time frame: Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85. Mean (Standard Deviation). Unit: mg/L

Measure	CP-751,871 10 mg/kg n = 16	CP-751,871 20 mg/kg n = 12
Value	225.1 (54.175)	420.6 (62.175)

Population analysed: All treated participants.

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

Time frame: Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85. Mean (Standard Deviation). Unit: mg*h/L

Measure	CP-751,871 10 mg/kg n = 16	CP-751,871 20 mg/kg n = 12
Value	80740 (14184)	184000 (27811)

Population analysed: All treated participants.

Primary outcome: Plasma Clearance (CL)

Time frame: Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85. Mean (Standard Deviation). Unit: mL/day/kg

Measure	CP-751,871 10 mg/kg n = 13	CP-751,871 20 mg/kg n = 12
Value	2.808 (0.3804)	2.353 (0.4346)

Population analysed: All treated and evaluable participants (had measurements related to the PK parameter stated above).

Primary outcome: Apparent Volume of Distribution (Vz)

Time frame: Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85. Mean (Standard Deviation). Unit: mL/kg

Measure	CP-751,871 10 mg/kg n = 13	CP-751,871 20 mg/kg n = 12
Value	84.89 (13.731)	92.17 (14.978)

Population analysed: All treated and evaluable participants (had measurements related to the PK parameter stated above).

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CP-751,871 10 mg/kg	0 of 16 (0%)	9 of 16 (56.3%)	Not reported
CP-751,871 20 mg/kg	0 of 12 (0%)	12 of 12 (100%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CP-751,871 and CP-751,871, moxifloxacin, saline in people with Healthy Volunteers, run by Pfizer at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Plasma Concentration (Cmax) (time frame: Day 1 pre-dose and 1 hour post-dose, Day 2 (24 hours post-dose), 8, 15, 22, 29, 43, 57, 71 and 85). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00926263.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2013.