The Bioavailability of a Spray Dried Dispersion Solid Dose Formulation of PF-06260414 Relative to a Suspension Formulation

A Phase 1 Single-dose Open Label 3-way Crossover Study To Evaluate The Bioavailability Of A Spray Dried Dispersion Solid Dose Formulation Of Pf-06260414 Relative To A Suspension Formulation Under Fasted Conditions And The Effect Of Food On The Bioavailability Of The Pf-06260414 Spray Dried Dispersion Solid Formulation In Healthy Subjects

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02393807

Enrollment

Registered

2015-03-19

Start date

2015-06-30

Completion date

2015-07-31

Last updated

2018-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Chronic Obstructive Pulmonary Disease

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.

Interventions

DRUGPF 06260414 solid dose formulation

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

DRUGPF-06260414 nanosuspension

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* 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)

Design outcomes

Primary

Measure	Time frame
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
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

Secondary

Measure	Time frame
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
AUCinf of PF-06260414	Hour 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026