SINGLE DOSE: Single Dose, Dose Escalation Healthy Volunteers Study Of PF-05105679

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01393652
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arms: 3
• Duration (Months): 4
• Patients Per Site Per Month: 7.9

Study Details

Study Description

Brief Summary

This is a two part study. The purpose of the first part (Part A) is the evaluation of the pharmacokinetics, safety and tolerability after single ascending dose of PF-05105679. The second part (Part B) of this study will focus on the exploratory pharmacodynamics of PF-05105679 using pharmacodynamics markers (cold detection) in healthy volunteers. The doses selected in Part B will have been administered previously in the Part A of the study.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: PF-05105679; Drug: PF-05105679; Drug: PF-05105679	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: A Phase I, Randomized, Placebo-Controlled, Dose Escalating Cross Over Study To Evaluate The Safety, Toleration, Pharmacokinetics And Pharmacodynamics Of PF-05105679 Under Fasted Conditions In Healthy Volunteers
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1: Experimental intervention: PF-05105679 or placebo Cohort 1	Drug: PF-05105679; Subjects will receive single ascending doses of PF-05105679 or placebo to investigate safety/tolerability and pharmacokinetics of PF-05105679
Experimental: Cohort 2: Experimental intervention: PF-05105679 or placebo Cohort 2	Drug: PF-05105679; Subjects will receive single ascending doses of PF-05105679 or placebo to investigate safety/tolerability and pharmacokinetics of PF-05105679
Active Comparator: Cohort 3: Experimental intervention PF-05105679 or placebo and Cohort 3	Drug: PF-05105679; Subject will be randomized to a treatment sequence, and assigned to placebo, 2 separate single doses of PF-05105679 in the fasted state and to controlled-release Oxycodone 20 mg (positive control) , with at least one week wash-out between doses.

Outcome Measures

Primary Outcome Measures

1. Number of participants with adverse events as a measure of safety and tolerability. [3 days]

2. Pharmacokinetics of single doses of PF-05105679 as measured by plasma concentrations- Cmax, Tmax, half life, AUC last, AUC(0-24) and MRT [3 days]

Secondary Outcome Measures

1. Average AUC2min VAS (cold pressor test) of PF-05105679. [24 hours]

2. Cold detection threshold (°C) of PF-05105679. [24 hours]

3. Cold pain threshold (°C) of PF-05105679. [24 hours]

4. Stimulus-response function to cold stimuli following menthol application. [24 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

Healthy Volunteers

Exclusion Criteria:

Standard Healthy Volunteers

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Bruxelles		Belgium	B-1070

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01393652
• Other Study ID Numbers: B3351001
• First Posted: Jul 13, 2011
• Last Update Posted: Oct 3, 2011
• Last Verified: Sep 1, 2011

• Keywords provided by Pfizer: Pharmacokinetics Safety Tolerability Pharmacodynamics

Study Results

No Results Posted as of Oct 3, 2011