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

PAIN Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01601834
• Other study ID #: B5261001
• Status: Completed
• Phase: Phase 1
• First received: April 27, 2012
• Last updated: July 3, 2012
• Start date: May 2012
• Est. completion date: June 2012

Study information

• Verified date: July 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: FAMHP(Federal Agency for Medicines and Healthy Products)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• PAIN

Intervention

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.
• 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.

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

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

External Links

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