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

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.

Study Overview

• Status: Withdrawn
• Conditions: Healthy
• Intervention / Treatment: Drug: PF 06260414 solid dose formulation; Drug: PF-06260414 nanosuspension

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Pfizer New Haven Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Open label single dose crossover study of PF-06260414; 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 formulation; Single dose of 30 mg PF-06260414 given under fed/fasted conditions; Drug: PF-06260414 nanosuspension; Single dose of 30 mg PF-06260414 given under fasted conditions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Pfizer

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (ANTICIPATED): July 1, 2015
• Study Completion (ANTICIPATED): July 1, 2015

Study Registration Dates

• First Submitted: March 9, 2015
• First Submitted That Met QC Criteria: March 13, 2015
• First Posted (ESTIMATE): March 19, 2015

Study Record Updates

• Last Update Posted (ACTUAL): November 14, 2018
• Last Update Submitted That Met QC Criteria: November 12, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Chronic Obstructive Pulmonary Disease
• Other Study ID Numbers: B7411002; SARM FOOD EFFECT & BE (OTHER: Alias Study Number); SARM FOOD EFFECT &BE (OTHER: Alias Study Number)