A First In Human Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Single Oral Doses Of PF-06273340

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01601834
First received: April 27, 2012
Last updated: July 3, 2012
Last verified: July 2012
  Purpose

The purpose of this study in healthy people is to evaluate safety, toleration and time course of plasma concentration of single oral doses of PF-06273340. The effect of food on the Pharmacokinetic of PF-06273340 may also be investigated.


Condition Intervention Phase
PAIN
Drug: PF-06273340 or Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A Double Blind (3rd Party Open) Randomized, Placebo Controlled, Crossover Dose Escalation Study To Investigate The Safety, Toleration And Pharmacokinetics Of Pf-06273340 In Healthy Volunteers

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Maximum observed plasma concentration (Cmax) [ Time Frame: 0,0.25,0.5,1,1.5,2,4,6,8,12,24,36,48,72 hours post-dose ] [ Designated as safety issue: No ]
  • Time of maximum concentration (Tmax) [ Time Frame: 0,0.25,0.5,1,1.5,2,4,6,8,12,24,36,48,72 hours post-dose ] [ Designated as safety issue: No ]
  • Area under the plasma concentration time profile from time zero to the time of last quantifiable concentration (AUClast) [ Time Frame: 0,0.25,0.5,1,1.5,2,4,6,8,12,24,36,48,72 hours post-dose ] [ Designated as safety issue: No ]
  • Area under the plasma concentration time profile from time zero extrapolated to inifinite time (AUCinf) [ Time Frame: 0,0.25,0.5,1,1.5,2,4,6,8,12,24,36,48,72 hours post-dose ] [ Designated as safety issue: No ]
  • Area under the plasma concentration time profile from time zero to quantifiable concentration 24 h post dose (AUC24) [ Time Frame: 0,0.25,0.5,1,1.5,2,4,6,8,12,24,36,48,72 hours post-dose ] [ Designated as safety issue: No ]
  • Apparent Clearance (CL/F) [ Time Frame: 0,0.25,0.5,1,1.5,2,4,6,8,12,24,36,48,72 hours post-dose ] [ Designated as safety issue: No ]
  • Apparent Volume of Distribution (Vz/F) [ Time Frame: 0,0.25,0.5,1,1.5,2,4,6,8,12,24,36,48,72 hours post-dose ] [ Designated as safety issue: No ]
  • t1/2 = Terminal Elimination half life [ Time Frame: 0,0.25,0.5,1,1.5,2,4,6,8,12,24,36,48,72 hours post-dose ] [ Designated as safety issue: No ]
  • Urine: Ae24 (amount excreted in urine), Ae24% (%dose excreted in urine to time 24 h) and CLr (Renal Clearance) for selected doses [ Time Frame: up to 24 h ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: May 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1: Experimental intervention: PF-06273340 or placebo
Subjects in Cohort 1 will receive single ascending doses of PF-06273340 or placebo to investigate the safety/tolerability and PK of PF-06273340. The effect of food on PK may also be investigated.
Drug: PF-06273340 or Placebo
PF-06273340 will be administered as an extemporaneously prepared solution for all doses. Correspondingly, placebo doses will be administered as solution.
Experimental: Cohort 2: Experimental intervention: PF-06273340 or placebo
Subjects in Cohort 2 will receive single ascending doses of PF-06273340 or placebo to investigate the safety/tolerability and PK of PF-06273340. The effect of food on PK may also be investigated.
Drug: PF-06273340 or Placebo
PF-06273340 will be administered as an extemporaneously prepared solution for all doses. Correspondingly, placebo doses will be administered as solution.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male subjects or female subjects of non-child bearing 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).
  • 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.

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).
  • Any condition possibly affecting drug absorption (e.g., gastrectomy).
  • A positive urine drug screen.
  • History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
  • Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
  • Screening supine blood pressure >= 140 mm Hg (systolic) or >= 90 mm Hg (diastolic), on a single measurement (confirmed by a single repeat, if necessary) following at least 5 minutes of rest.
  • 12-lead ECG demonstrating QTc >450 msec at screening. If QTc exceeds 450 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.
  • Females of child bearing potential.
  • Use of prescription or non-prescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. Herbal supplements must be discontinued 28 days prior to the first dose of study medication. As an exception, acetaminophen/paracetamol may be used at doses of 1 g/day. Limited use of non-prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.
  • Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing. History of sensitivity to heparin or heparin-induced thrombocytopenia.
  • Unwilling or unable to comply with the Lifestyle guidelines described in this protocol.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01601834

Locations
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, B-1070
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01601834     History of Changes
Other Study ID Numbers: B5261001
Study First Received: April 27, 2012
Last Updated: July 3, 2012
Health Authority: Belgium: FAMHP(Federal Agency for Medicines and Healthy Products)

Keywords provided by Pfizer:
Phase 1
Single Dose
Pharmacokinetics
Safety
Toleration

ClinicalTrials.gov processed this record on September 18, 2014