NCT01351129

Brief Summary

The primary purpose of this study is to evaluate the pharmacokinetics, safety and tolerability three different formulations of PF-04991532 in healthy adult subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started May 2011

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 10, 2011

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

July 6, 2011

Status Verified

July 1, 2011

Enrollment Period

1 month

First QC Date

May 9, 2011

Last Update Submit

July 5, 2011

Conditions

Healthy

Keywords

formulation comparison

Outcome Measures

Primary Outcomes (1)

  • Area under the plasma concentration versus time profile (AUC)

    predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12,24,36,48 hrs postdose

Secondary Outcomes (3)

  • Max observed plasma concentration (Cmax)

    predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12,24,36,48 hrs postdose

  • Time of Cmax (Tmax)

    predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12,24,36,48 hrs postdose

  • Concentration at 24 hours postdose (C24hr)

    24 hrs postdose

Study Arms (3)

Formulation 1

EXPERIMENTAL
Drug: Formulation 1

Formulation 2

EXPERIMENTAL
Drug: Formulation 2

Formulation 3

EXPERIMENTAL
Drug: Formulation 3

Interventions

Formulation 1DRUG

150-mg immediate release tablet (single dose)

Formulation 1
Formulation 2DRUG

150-mg modified release capsule, short duration (single dose)

Formulation 2
Formulation 3DRUG

150-mg modified release capsule, long duration (single dose)

Formulation 3

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and/or female (non-childbearing potential) subjects between the ages of 21 and 55 years, inclusive.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
  • An informed consent document signed and dated by the subject.

You may not qualify if:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • A positive urine drug screen.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Singapore, 188770, Singapore

Location

Related Links

MeSH Terms

Interventions

Akacid-medical-formulation

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 9, 2011

First Posted

May 10, 2011

Study Start

May 1, 2011

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

July 6, 2011

Record last verified: 2011-07

Locations

SG(1)