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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02393807
• Other study ID #: B7411002
• Secondary ID: SARM FOOD EFFECT
• Status: Withdrawn
• Phase: Phase 1
• Start date: June 2015
• Est. completion date: July 2015

Study information

• Verified date: November 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PF 06260414 solid dose formulation
Single dose of 30 mg PF-06260414 given under fed/fasted conditions
• PF-06260414 nanosuspension
Single dose of 30 mg PF-06260414 given under fasted conditions

Locations

Country	Name	City	State
United States	Pfizer New Haven Clinical Research Unit	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	AUCinf of PF-06260414		Hour 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose
Secondary	t½ of PF-06260414		Hour 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose
Secondary	Tmax of PF-06260414		Hour 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36 and 48 hours postdose