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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PF-06427878

• Registration Number: NCT02237742
• Lead Sponsor: Pfizer

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 available

Study Timeline

• Study First Submitted: 2014-09-09
• Study First Submitted QC: 2014-09-09
• Study First Posted: 2014-09-11
• Study Start: 2014-11
• Primary Completion: 2014-11
• Study Completion: 2014-12
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-12
• Last Update Posted: 2018-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PF-06427878	PF-06427878	-

Primary Outcome Measures

Name	Time	Method
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
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
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
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
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
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 Outcome Measures

Name	Time	Method
Amount of unchanged drug excreted in urine from time 0 to 12.5 hours (Ae12.5)	Day 1 Hr 0 to 12.5
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
Renal clearance (CLr)	Day 1 Hr 0 to 12.5

Trial Locations

Locations (1)

Quotient Clinical Ltd; 🇬🇧 Ruddington, Nottingham, United Kingdom