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

Phase 1

Withdrawn

• Conditions: Healthy
• Interventions: Drug: PF 06260414 solid dose formulation; Drug: PF-06260414 nanosuspension

• Registration Number: NCT02393807
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-09
• Study First Submitted QC: 2015-03-13
• Study First Posted: 2015-03-19
• Study Start: 2015-06
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-12
• Last Update Posted: 2018-11-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Open label single dose crossover study of PF-06260414	PF 06260414 solid dose formulation	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
Open label single dose crossover study of PF-06260414	PF-06260414 nanosuspension	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer New Haven Clinical Research Unit; 🇺🇸 New Haven, Connecticut, United States