NCT02711462|TerminatedPhase 1

Study Stopped

The study was prematurely terminated on 06 October 2016 due to the potential risk of further dosing in healthy subjects

Study in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06687234

A Phase 1, Double Blind, Third-Party Open, Randomized, Placebo Controlled, Single And Multiple Dose, Parallel Group Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-06687234 In Healthy Subjects

Pfizer ClinicalTrials.gov

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3 other identifiers

B75810012015-000710-22DEKAVIL

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredMar 2016

StartedFeb 2016

CompletionAug 2016

Brief Summary

This Phase 1 study will be a double blind, third party open (ie, subject blind, investigator blind and Sponsor open), randomized, placebo controlled, single and multiple dose escalation study in healthy subjects, females of non childbearing potential and males between the ages of 18 and 55 years, inclusive. There may be up to 11 Cohorts in the study. Approximately 7 cohorts are anticipated in the Single Dose (SD) portion of the study and up to 4 cohorts are anticipated in the Multiple Dose (MD) portion of the study. Following the last subject Day 28 visit from the first two single dose cohorts (Cohorts 1 and 2), all available data inclusive of Day 28 will be evaluated for PK, immunogenicity, safety and tolerability. FDA review and agreement to move forward will take place before the remaining single dose cohorts and the multiple dose phase (Cohorts 3 to 11) can be initiated. A total of up to approximately 82 subjects are anticipated to be enrolled in the study. The duration of dosing in the multiple dose cohorts would be 4 weeks and the regimen may include weekly (total of 5 doses), every 2 weeks (total of 3 doses) or monthly dosing (total of two doses).

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_1 healthy

Timeline

Completed

Started Feb 2016

Typical duration for phase_1 healthy

Geographic Reach

1 country

1 active site

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6 months study duration

First Submitted

Initial submission to the registry

January 8, 2016

Completed

24 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed

2 months until next milestone

First Posted

Study publicly available on registry

March 17, 2016

Completed

5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed

Last Updated

November 7, 2016

Status Verified

November 1, 2016

Enrollment Period

6 months

First QC Date

January 8, 2016

Last Update Submit

November 4, 2016

Conditions

Healthy

Keywords

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

Number of Participants with Adverse Events (AEs)
To determine the safety and tolerability of PF 06687234 by assessing averse events, vital signs measurements, 12 lead ECGs, physical examination findings, blood and urine safety tests including ferritin, transferrin, serum iron, reticulocytes, hemoglobin, platelets and any abnormal laboratory results.
4 weeks in the single dose portion and 8 weeks in the multiple dose portion

Secondary Outcomes (12)

Maximum Observed Plasma Concentration (Cmax) of PF 06687234 (IV and SC single doses)
Day 1 prior to 0 hr & 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post dose and 8 and 11 days post dose along with early termination or follow up visit.
Maximum Observed Plasma Concentration (Cmax) of PF 06687234 (SC multiple doses)
Day 1 and Day 29 prior to 0 hr & 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post dose. Pre-dose samples on Day 8, 15, 22, 36, 39 and 43 along with early termination or follow up visit.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF 06687234 (IV and SC single doses)
Day 1 prior to 0 hr & 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post dose and 8 and 11 days post dose along with early termination or follow up visit.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF 06687234 (SC multiple doses)
Day 1 and Day 29 prior to 0 hr & 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post dose. Pre-dose samples on Day 8, 15, 22, 36, 39 and 43 along with early termination or follow up visit.
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF 06687234 (IV and SC single doses)
Day 1 prior to 0 hr & 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post dose and 8 and 11 days post dose along with early termination or follow up visit.
+7 more secondary outcomes