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

NCT01365637 | Completed Phase 1

• 1 other identifier: B3291002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain

Keywords

safety; tolerability; pharmacokinetics; PF-05089771

Outcome Measures

Primary Outcomes (5)

• Number of participants with adverse events as a measure of safety and tolerability of PF-05089771

  Days 1-16

• Maximum concentration (Cmax) for PF-05089771 in plasma (measured in ng/mL)

  Days 1-16

• Tmax = Time of maximum concentration of PF-05089771 in plasma (hr)

  Days 1-16

• AUCtau= Area under the curve from the time of dosing to the next dose (ng.hr/mL)

  Days 1-16

• Elimination half life (hr) = rate of elimination of PF-05089771 after the final dose

  Days 14-16

Secondary Outcomes (1)

• AUCinf = Area under the curve from the time of dosing extrapolated to infinity (ng.hr/mL)

  Days 14-16

Study Arms (4)

Cohort 1 PF-05089771 or placebo

EXPERIMENTAL

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.

Drug: PF-05089771

Cohort 2 PF-05089771 or placebo

EXPERIMENTAL

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.

Drug: PF-05089771

Cohort 3 PF-05089771 or placebo

EXPERIMENTAL

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.

Drug: PF-05089771

Cohort 4 PF-05089771 or placebo

EXPERIMENTAL

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.

Drug: PF-05089771

Interventions

PF-05089771 DRUG

PF-05089771 will be dosed as a suspension twice daily

Cohort 1 PF-05089771 or placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

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).
• 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.
• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Brussels, B-1070, Belgium

Location

Related Links

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

MeSH Terms

Conditions

Pain

Interventions

PF-05089771

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2011
• First Posted: June 3, 2011
• Study Start: June 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 6, 2011

Record last verified: 2011-10

Locations

BE (1)