NCT02286882|TerminatedPhase 1

Study Stopped

The trial was terminated prematurely on June 19, 2015 for business reasons. There were no safety concerns in the study which led to the decision.

A Single Oral Dose Study Of PF-06409577 In Healthy Adult Subjects

A Phase 1, Randomized, Double-blind, Placebo-controlled, Parallel Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Single Ascending Oral Doses Of Pf-06409577 In Healthy Adult Subjects

Pfizer ClinicalTrials.gov

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3 other identifiers

B7881001FIH2014-004022-18

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredNov 2014

StartedNov 2014

CompletionJun 2015

Brief Summary

PF-06409577 is a new compound proposed for the treatment of diabetic nephropathy. The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single oral doses of PF-06409577 in healthy adult subjects.

Trial Health

Monitor

Trial Health Score

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

Enrollment

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline

Completed

Started Nov 2014

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

7 months study duration

Study Start

First participant enrolled

November 1, 2014

Completed

5 days until next milestone

First Submitted

Initial submission to the registry

November 6, 2014

Completed

4 days until next milestone

First Posted

Study publicly available on registry

November 10, 2014

Completed

7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed

Last Updated

July 20, 2015

Status Verified

July 1, 2015

Enrollment Period

7 months

First QC Date

November 6, 2014

Last Update Submit

July 16, 2015

Conditions

Healthy

Keywords

Single Ascending Dosehealthy subjects

Outcome Measures

Primary Outcomes (5)

Number of Participants With Adverse Events (AEs)
0-48 hours post dose
Number of Participants With Laboratory Test Values of Potential Clinical Importance
0-48 hours post dose
Number of Participants With Vital Signs Findings (Including Bood Pressure and Pulse Rate) of Potential Clinical Importance
0-48 hours post dose
Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance
0-48 hours post dose
Number of Participants With Echocardiogram Findings of Potential Clinical Importance
0-48 hours post dose

Secondary Outcomes (11)

Area Under the Curve From Time Zero to Time 24 hours (AUC24) for PF-06409577
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06409577
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - infinity)] for PF-06409577
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Maximum Observed Plasma Concentration (Cmax) for PF-06409577
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06409577
0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
+6 more secondary outcomes