A Study To Understand How The Body Reacts To A Low Dose Of PF-06427878 When Given In A Vein To Healthy, Adult, Males
NCT02237742
Last updated date
ABOUT THIS STUDY
To determine how the body reacts to a low dose of PF-06427878 when given in a vein over 30
minutes to healthy, adult, males.
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
1. Healthy male subjects between 18-55 years of age
2. BMI of 17.5-30.5 kg/m2
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
1. History of drug or alcohol abuse within 2 years of screening
2. Subjects without suitable veins for multiple venipuncture/cannulation
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Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | A Study To Understand How The Body Reacts To A Low Dose Of PF-06427878 When Given In A Vein To Healthy, Adult, Males | |||
| Official Title ICMJE | A Phase 1, Non-Randomized, Open-Label, Single-Dose, Single Period Study With Non-Pharmacologically Active Dose Of Pf-06427878 To Characterize Pharmacokinetics Following Intravenous Administration In Healthy, Adult, Male Subjects | |||
| Brief Summary | To determine how the body reacts to a low dose of PF-06427878 when given in a vein over 30 minutes to healthy, adult, males. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 1 | |||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Basic Science | |||
| Condition ICMJE | Healthy | |||
| Intervention ICMJE | Drug: PF-06427878
Intravenous, 100 micrograms, single dose, 30 minute infusion | |||
| Study Arms ICMJE | Experimental: PF-06427878
Intervention: Drug: PF-06427878 | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 6 | |||
| Original Estimated Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | December 2014 | |||
| Actual Primary Completion Date | November 2014 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years to 55 Years (Adult) | |||
| Accepts Healthy Volunteers ICMJE | Yes | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United Kingdom | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT02237742 | |||
| Other Study ID Numbers ICMJE | B7871004 2014-002626-12 ( EudraCT Number ) | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | November 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||