The Safety and Tolerability of PF-05089771 Will be Investigated in Healthy Subjects Over a 14 Day Dosing Period.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01365637
First received: June 1, 2011
Last updated: October 4, 2011
Last verified: October 2011

June 1, 2011
October 4, 2011
June 2011
September 2011   (final data collection date for primary outcome measure)
  • Number of participants with adverse events as a measure of safety and tolerability of PF-05089771 [ Time Frame: Days 1-16 ] [ Designated as safety issue: Yes ]
  • Maximum concentration (Cmax) for PF-05089771 in plasma (measured in ng/mL) [ Time Frame: Days 1-16 ] [ Designated as safety issue: No ]
  • Tmax = Time of maximum concentration of PF-05089771 in plasma (hr) [ Time Frame: Days 1-16 ] [ Designated as safety issue: No ]
  • AUCtau= Area under the curve from the time of dosing to the next dose (ng.hr/mL) [ Time Frame: Days 1-16 ] [ Designated as safety issue: No ]
  • Elimination half life (hr) = rate of elimination of PF-05089771 after the final dose [ Time Frame: Days 14-16 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01365637 on ClinicalTrials.gov Archive Site
AUCinf = Area under the curve from the time of dosing extrapolated to infinity (ng.hr/mL) [ Time Frame: Days 14-16 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Safety and Tolerability of PF-05089771 Will be Investigated in Healthy Subjects Over a 14 Day Dosing Period.
A Double Blind (3rd Party Open) Randomized, Placebo Controlled, Parallel Group Multiple Dose Escalation Study To Investigate The Safety, Toleration And Pharmacokinetics Of PF-05089771 In Healthy Subjects.

The purpose of the study is primarily to determine the safety and toleration and pharmacokinetics of PF-05089771 following escalating multiple doses lasting for 14 days. Dosing will either be administered twice or three times daily. Secondary objectives will be to investigate the PK of an alternative formulation of PF-05089771 and the effect of food on the PK of PF-05089771.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Pain
  • Drug: PF-05089771
    PF-05089771 will be dosed as a suspension twice daily
  • Drug: PF-05089771
    PF-05089771 will be dosed as a suspension either twice or thrice daily
  • Experimental: Cohort 1 PF-05089771 or placebo
    Subjects will receive multiple doses of PF-05089771 or placebo twice daily to investigate the safety/tolerability and PK of PF-05089771. The PK of alternative formulations of PF-05089771 and the effect of food on PK may also be investigated.
    Intervention: Drug: PF-05089771
  • Experimental: Cohort 2 PF-05089771 or placebo
    Subjects will receive multiple doses of PF-05089771 or placebo twice daily to investigate the safety/tolerability and PK of PF-05089771. The PK of alternative formulations of PF-05089771 and the effect of food on PK may also be investigated.
    Intervention: Drug: PF-05089771
  • Experimental: Cohort 3 PF-05089771 or placebo
    Subjects will receive multiple doses of PF-05089771 or placebo either twice or thrice daily to investigate the safety/tolerability and PK of PF-05089771. The PK of alternative formulations of PF-05089771 and the effect of food on PK may also be investigated.
    Intervention: Drug: PF-05089771
  • Experimental: Cohort 4 PF-05089771 or placebo
    Subjects will receive multiple doses of PF-05089771 or placebo either twice or thrice daily to investigate the safety/tolerability and PK of PF-05089771. The PK of alternative formulations of PF-05089771 and the effect of food on PK may also be investigated.
    Intervention: Drug: PF-05089771
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
September 2011
September 2011   (final data collection date for primary outcome measure)

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 21 drinks/week (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 60 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
  • 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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01365637
B3291002
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP