Clinical trial NCT01165723: A Clinical Study Evaluating The Safety And Tolerability Of PF-04427429 In Healthy Adult Volunteers. The Pharmacokinetics And Pharmacodynamics Of PF-04427429 Will Also Be Investigated
Official title: A Randomised, Placebo Controlled, Double-Blind, Third Party Open, Parallel Group Study To Evaluate the Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Repeat Doses PF-04427429 Administered Intravenously To Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: safety
tolerability
pharmacokinetics
pharmacodynamics
chronic pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-07-20
Enrollment: 21
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-04472429 administered intravenously to healthy adult volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects between the ages of 18 and 50 years inclusive. (healthy is defined as non 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 30.5 kg/m2; and a total body weight of 50 to 100kg inclusive
* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial

Exclusion Criteria:

* Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, genitourinary, psychiatric, neurologic or allergic disease (including drug allergies, but excluding untreated symptomatic, seasonal allergies at time of dosing)
* History of febrile illness within 5 days prior to the first dose
* A positive urine drug screen

Primary outcomes:
measure: Safety (incidence/severity of adverse events and clinical laboratory abnormalities, mean change from baseline/placebo in vital signs/body temperature, mean change from baseline in 12 lead electrocardiogram parameters compared to baseline/placebo)
timeFrame: up to 129 days
measure: Safety continued (categorical summary of QTcF compared to baseline between dose groups and placebo, concentration QTcF relationship, ADA responses, IV injection site reactions
timeFrame: up to 129 days
measure: Pharmacokinetics (free plasma concentrations of PF-04427429 will be measured by a validated assay and non-compartmental PK parameters will be determined for each dose)
timeFrame: up to 129 days
Secondary outcomes:
measure: pharmacodynamics (free and total CGRP plasma concentration) will be measured, the PK-PD relationship between plasma PF-0447429 concentrations and free/total CGRP concentrations will be characterised
timeFrame: up to 129 days
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: