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

Sponsor

Pfizer (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT02393807

Collaborator

(none)

Enrollment

Location

Arm

Duration (Days)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: PF 06260414 solid dose formulation Drug: PF-06260414 nanosuspension	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Jun 1, 2015

Anticipated Primary Completion Date :

Jul 1, 2015

Anticipated Study Completion Date :

Jul 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer New Haven Clinical Research Unit	New Haven	Connecticut	United States	06511

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT02393807

Other Study ID Numbers:

B7411002
SARM FOOD EFFECT & BE
SARM FOOD EFFECT &BE

First Posted:

Mar 19, 2015

Last Update Posted:

Nov 14, 2018

Last Verified:

Nov 1, 2018

Keywords provided by Pfizer

Chronic Obstructive Pulmonary Disease

Study Results

No Results Posted as of Nov 14, 2018