Study Of The PF-04958242 Blood Concentrations Of A Capsule Formulation Of PF-04958242 Compared To A Solution Formulation

• Sponsor: Biogen (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01646840
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 2
• Duration (Months): 2
• Patients Per Site Per Month: 5.9

Study Details

Study Description

Brief Summary

This study will assess the relative bioavailability of a capsule formulation of PF-04958242, relative to a oral solution formulation of PF-04958242 in healthy adult subjects.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: PF-04958242 capsule; Drug: PF-04958242 oral solution	Phase 1

Detailed Description

This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: a Phase 1, Open-Label, Single Dose, Relative Bioavailability Study In Healthy Volunteers Comparing PF-04958242 Capsule Formulation To PF-04958242 Oral Solution In The Fasted State
• Study Start Date: Jul 1, 2012
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PF-04958242 capsule	Drug: PF-04958242 capsule; Single dose of PF-04958242 0.35 mg oral capsule
Active Comparator: PF-04958242 oral solution	Drug: PF-04958242 oral solution; Single dose of PF-04958242 0.35 mg oral solution

Outcome Measures

Primary Outcome Measures

1. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 120, and 192 hours post-dose]

2. Maximum Observed Plasma Concentration (Cmax) [0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 120, and 192 hours post-dose]

3. Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04958242 [0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 120, and 192 hours post-dose]

4. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] [0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 120, and 192 hours post-dose]

5. Plasma Decay Half-Life (t1/2) [0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 120, and 192 hours post-dose]

6. Apparent Oral Clearance (CL/F) [0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 120, and 192 hours post-dose]

7. Apparent Volume of Distribution (Vz/F) [0.25, 0.5, 0.75, 1, 1.5, 2, 4, 8, 12, 24, 48, 72, 120, and 192 hours post-dose]

8. Number of Participants with categorical scores on the Columbia Suicide Severity Rating Scale (C-SSRS) [4 and 192 hours post-dose]

Secondary Outcome Measures

1. no secondary endpoints [no secondary endpoints]

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 (of non childbearing potential) subjects between the ages of 18 and 55 years

• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

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 Investigational Site	New Haven	Connecticut	United States	06511

Sponsors and Collaborators

• Biogen

Investigators

• Study Director: Medical Director, Biogen

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Biogen
• ClinicalTrials.gov Identifier: NCT01646840
• Other Study ID Numbers: B1701010
• First Posted: Jul 20, 2012
• Last Update Posted: Nov 21, 2019
• Last Verified: Nov 1, 2019

• Keywords provided by Biogen: PF-04958242; bioequivalence; pharmacokinetics; Schizophrenia

Study Results

No Results Posted as of Nov 21, 2019