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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01365637
• Date of registration: 01/06/2011
• Primary sponsor: Pfizer
• Public title: The Safety and Tolerability of PF-05089771 Will be Investigated in Healthy Subjects Over a 14 Day Dosing Period.
• Scientific title: 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.
• Date of first enrolment: June 2011
• Target sample size: 30
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01365637
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Countries of recruitment

Belgium

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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 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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Pain

Intervention(s)

Drug: PF-05089771

Primary Outcome(s)

AUCtau= Area under the curve from the time of dosing to the next dose (ng.hr/mL) [Time Frame: Days 1-16]

Elimination half life (hr) = rate of elimination of PF-05089771 after the final dose [Time Frame: Days 14-16]

Maximum concentration (Cmax) for PF-05089771 in plasma (measured in ng/mL) [Time Frame: Days 1-16]

Number of participants with adverse events as a measure of safety and tolerability of PF-05089771 [Time Frame: Days 1-16]

Tmax = Time of maximum concentration of PF-05089771 in plasma (hr) [Time Frame: Days 1-16]

Secondary Outcome(s)

AUCinf = Area under the curve from the time of dosing extrapolated to infinity (ng.hr/mL) [Time Frame: Days 14-16]

Secondary ID(s)

B3291002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors