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NCT02237742 Clinical Trial

A Study To Understand How The Body Reacts To A Low Dose Of PF‑06427878 When Given In A Vein To Healthy, Adult, Males

Healthy Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02237742
Other study ID # B7871004
Secondary ID 2014-002626-12
Status Completed
Phase Phase 1
First received
Last updated
Start date November 2014
Est. completion date December 2014

Study information
Verified date November 2018
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 6
Est. completion date December 2014
Est. primary completion date November 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

1. Healthy male subjects between 18-55 years of age

2. BMI of 17.5-30.5 kg/m2

Exclusion Criteria:

1. History of drug or alcohol abuse within 2 years of screening

2. Subjects without suitable veins for multiple venipuncture/cannulation

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• PF-06427878
Intravenous, 100 micrograms, single dose, 30 minute infusion

Locations
Country Name City State
United Kingdom Quotient Clinical Ltd Ruddington Nottingham

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Area Under the Plasma Curve From Time Zero to Last Quantifiable Concentration (AUClast) Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5
Primary Area under the Plasma Concentration-Time Curve From Time Zero extrapolated to Infinite Time (AUCinf) Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5
Primary Maximum Observed Plasma Concentration (Cmax) Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5
Primary Plasma Terminal Elimination Half Life (t1/2) Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5
Primary Plasma Systemic Clearance (CL) Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5
Primary Plasma Volume of Distribution at Steady State (Vss) Day 1 Min 0,5,15,30,35,45,60,75,90, Hr 2,2.5,3.5,4.5,5.5,6.5,8.5,10.5,12.5,24.5
Secondary Amount of unchanged drug excreted in urine from time 0 to 12.5 hours (Ae12.5) Day 1 Hr 0 to 12.5
Secondary Percent of dose excreted in urine as unchanged drug from time zero to 12.5 hours (Ae12.5%) Day 1 Hr 0 to 12.5
Secondary Renal clearance (CLr) Day 1 Hr 0 to 12.5
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