NCT02393807

Brief Summary

The current study will investigate the relative bioavailability of a spray dried dispersion solid dose formulation of PF 06260414 administered as a single oral dose of 30 mg of PF 06260414 relative to a single oral dose of 30 mg of PF 06260414 administered as a nanosuspension under fasted or fed conditions in healthy adult subjects.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2015

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

March 9, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 19, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

1 month

First QC Date

March 9, 2015

Last Update Submit

November 12, 2018

Conditions

Healthy

Keywords

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (4)

  • Single dose pharmacokinetics under fasted condition: Cmax of PF- 06260414 formulations

    Hour 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose

  • Single dose pharmacokinetics under fasted condition: AUClast of PF- 06260414 formulations

    Hour 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose

  • Single dose pharmacokinetics under fed condition: Cmax of PF- 06260414 formulations

    Hour 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose

  • Single dose pharmacokinetics under fed condition: AUClast of PF- 06260414 formulations

    Hour 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose

Secondary Outcomes (3)

  • AUCinf of PF-06260414

    Hour 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose

  • t½ of PF-06260414

    Hour 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose

  • Tmax of PF-06260414

    Hour 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose

Study Arms (1)

Open label single dose crossover study of PF-06260414

EXPERIMENTAL

This will be a Phase 1, open label, randomized, single dose, 3 period, 3 way crossover study to evaluate the relative bioavailability of solid dose formulation of PF 06260414 under fasted conditions compared to the nanosuspension under fasted conditions

Drug: PF 06260414 solid dose formulationDrug: PF-06260414 nanosuspension

Interventions

PF 06260414 solid dose formulationDRUG

Single dose of 30 mg PF-06260414 given under fed/fasted conditions

Open label single dose crossover study of PF-06260414
PF-06260414 nanosuspensionDRUG

Single dose of 30 mg PF-06260414 given under fasted conditions

Open label single dose crossover study of PF-06260414

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and/or female subjects of non childbearing potential between the ages of 18 and 55 years, inclusive.

You may not qualify if:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
  • Any condition possibly affecting drug absorption (eg, gastrectomy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2015

First Posted

March 19, 2015

Study Start

June 1, 2015

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

November 14, 2018

Record last verified: 2018-11

Locations

US(1)