Cold Pressor Test is Used in This Study to Assess the Effect of PF-06305591 on Pain Intensity Evoked by Cold in Healthy Male Subjects
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ClinicalTrials.gov Identifier: NCT01812265 |
Recruitment Status :
Completed
First Posted : March 18, 2013
Last Update Posted : September 17, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: PF-06305591 Drug: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 16 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Basic Science |
Official Title: | A Double Blind (3rd Party Open), Randomized, Placebo Controlled, Crossover Study To Investigate The Effects Of Pf-06305591 On Cold Pain In Healthy Male Subjects |
Study Start Date : | June 2013 |
Actual Primary Completion Date : | August 2013 |
Actual Study Completion Date : | August 2013 |
Arm | Intervention/treatment |
---|---|
Experimental: PF-06305591 Dose 1 |
Drug: PF-06305591
single Dose |
Experimental: PF-06305591 Dose 2 |
Drug: PF-06305591
single Dose |
Placebo Comparator: Placebo |
Drug: Placebo
Single Dose |
- Change From Baseline in Visual Analogue Scale (VAS) Score at time X, measured within a 2 minute interval [ Time Frame: 24h ]Change from Baseline in 10 cm VAS pain score; 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Change = scores at observation minus score at Baseline in a 2 minute assessment.
- Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 24h ]
- Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] [ Time Frame: 24h ]

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy male subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests.
- Body Mass Index (BMI) of 17.5 to 35 kg/m2; and a total body weight >50 kg (110 lbs).
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 the time of dosing).
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- Subjects unable to tolerate pre-study Cpressor testing at screening.
- Subjects with an average pain (AUC 0 to 120 sec) in the pre-study Cpressor test of less than or equal to 20.
- Broken skin on hands or forearms

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01812265
Belgium | |
Pfizer Investigational Site | |
Bruxelles, Belgium, B-1070 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT01812265 |
Other Study ID Numbers: |
B5281003 |
First Posted: | March 18, 2013 Key Record Dates |
Last Update Posted: | September 17, 2013 |
Last Verified: | September 2013 |