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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02237742
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arm: 1
• Duration (Days): 30
• Patients Per Site Per Month: 6.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: PF-06427878	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• 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
• Study Start Date: Nov 1, 2014
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PF-06427878	Drug: PF-06427878; Intravenous, 100 micrograms, single dose, 30 minute infusion

Outcome Measures

Primary Outcome Measures

1. 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]

2. 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]

3. 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]

4. 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]

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]

6. 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

1. Amount of unchanged drug excreted in urine from time 0 to 12.5 hours (Ae12.5) [Day 1 Hr 0 to 12.5]

2. 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]

3. Renal clearance (CLr) [Day 1 Hr 0 to 12.5]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Quotient Clinical Ltd	Ruddington	Nottingham	United Kingdom	NG11 6JS

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT02237742
• Other Study ID Numbers: B7871004; 2014-002626-12
• First Posted: Sep 11, 2014
• Last Update Posted: Nov 14, 2018
• Last Verified: Nov 1, 2018

Study Results

No Results Posted as of Nov 14, 2018