Investigation Of The Metabolism, And Excretion Of [14c]-PF-05212384 In Healthy Male Volunteers

NCT02142920 | Completed Phase 1

• 1 other identifier: B2151006
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to characterize how PF-05212384 is metabolized in the body following a single intravenous dose of radioactively labeled drug (\[14C\]-PF-05212384).

Conditions

Healthy

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• Maximum Observed Plasma Concentration (Cmax)

  0.5 hours

• Time to Reach Maximum Observed Plasma Concentration (Tmax)

  0.5 hours

Secondary Outcomes (5)

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

  9 Days

• Area under the Concentration-Time Curve (AUC)

  9 days

• Plasma Decay Half-Life (t1/2)

  9 days

• Systemic Clearance (CL)

  9 days

• Volume of Distribution at Steady State (Vss)

  9 days

Study Arms (1)

[14C] PF 05212384

EXPERIMENTAL

Receive PF-05212384 89 mg Dose

Drug: PF-05212384

Interventions

PF-05212384 DRUG

Single 89 mg Dose via 30 minute IV infusion

[14C] PF 05212384

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male subjects between the ages of 30- 65 years vasectomised or \>40 with no desire to father children in the near future (12 months), 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 35 kg/m2; and a total body weight \>50 kg (110 lbs).
• Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
• Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
• Subjects agree to use an adequate method of contraception

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).
• A positive urine drug screen or history of drug or alcohol abuse in the past 2 years.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Ruddington Fields, Nottingham, NG11 6JS, United Kingdom

Location

Related Publications (1)

• Houk BE, Alvey CW, Visswanathan R, Kirkovsky L, Matschke KT, Kimoto E, Ryder T, Obach RS, Durairaj C. Distribution, Metabolism, and Excretion of Gedatolisib in Healthy Male Volunteers After a Single Intravenous Infusion. Clin Pharmacol Drug Dev. 2019 Jan;8(1):22-31. doi: 10.1002/cpdd.615. Epub 2018 Sep 26.

  PMID: 30256541 DERIVED

Related Links

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

MeSH Terms

Interventions

gedatolisib

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: May 13, 2014
• First Posted: May 20, 2014
• Study Start: July 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: September 4, 2014

Record last verified: 2014-09

Locations

GB (1)