A Study To Understand How Radiolabelled PF-04449913 Is Taken Up By The Body, Broken Down And Then Removed From The Body

NCT02110342 | Completed Phase 1

• 1 other identifier: B1371009
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to understand, using radiolabelled PF-04449913, how this compound is modified by the body once it is absorbed. The study also aims to understand how much of the compound is broken down and how much leaves the body unchanged.

Conditions

Healthy

Keywords

PF-04449913; [14C]PF-04449913; Human ADME; Radiolabel; Mass Balance; Pharmacokinetics

Outcome Measures

Primary Outcomes (7)

• Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]

  AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).

  7 days

• Maximum Observed Plasma Concentration (Cmax)

  7 days

• Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] for total radioactivity related to drug product

  AUC (0 - 8)= Area under the plasma radioactivity concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).

  7 days

• Maximum Observed Plasma Concentration (Cmax) for total radioactivity related to drug product

  7 days

• Cumulative recovery of radioactivity in excreta

  Total percentage of dosed radioactivity recovered in urine and feces

  7 days

• Radioactivity in blood

  Total percentage of radioactivity in blood related to drug product

  7 days

• Urine PF-04449913 PK parameters

  Measure of renal clearance (CLr), amount excreted unchanged in urine (Ae) and the fraction of dose excreted unchanged in urine (AE%)

  7 days

Secondary Outcomes (4)

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

  7 days

• Plasma Decay Half-Life (t1/2)

  7 days

• Apparent Oral Clearance (CL/F)

  7 days

• Apparent Volume of Distribution (Vz/F)

  7 days

Study Arms (1)

Treatment

EXPERIMENTAL

Drug: [14C] PF-04449913

Interventions

[14C] PF-04449913 DRUG

Single oral dose of 100 mg PF-04449913 + 100µCi of \[14C\] PF-04449913

Treatment

Eligibility Criteria

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

You may qualify if:

• Healthy male subjects between the ages of 18 and 55 years (inclusive):Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests.
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
• An informed consent document signed and dated by the subject.
• Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

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).
• Subjects enrolled in a previous radionucleotide study or who have received radiotherapy within 12 months prior to screening or such that total radioactivity would exceed acceptable dosimetry.
• A positive urine drug screen or urine cotinine test
• lead ECG demonstrating QTc \>450 or a QRS interval \>120 msec msec at Screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTc values should be used to determine the subject's eligibility. Subjects with family history of myocardial infarction, congenital long QT syndrome, torsades de pointes or clinically significant ventricular arrhythmias. Subjects should be within normal range of potassium, magnesium and calcium at screening.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Madison, Wisconsin, 53704, United States

Location

Related Links

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

MeSH Terms

Interventions

glasdegib

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2014
• First Posted: April 10, 2014
• Study Start: May 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 22, 2014

Record last verified: 2014-07

Locations

US (1)