A Comparison Of The Pharmacokinetics Of PF-04191834 Following Single Dose Administration Of A Dispersion Formulation And A Suspension Formulation In Healthy Volunteers

NCT01265732 | Withdrawn Phase 1

• 1 other identifier: B0041012
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study investigates the safety, tolerability and pharmacokinetics of PF-04191834 when respectively given orally as a single dispersion dose and a single dose of a suspension. The suspension is the test formulation and the dispersion is the formulation with which the novel preparation will be compared.

Conditions

Healthy

Keywords

Phase 1; relative bioavailability; healthy volunteers; pharmacokinetics; suspension; dispersion

Outcome Measures

Primary Outcomes (3)

• Time of maximum concentration(Tmax) of PF-04191834 in plasma.

  3 days

• Area under the curve (AUClast) from the time of dosing to the last data point taken for PF-04191834.

  3 days

• Area under the curve from the time of dosing extrapolated to infinity(AUCinf) of PF-04191834.

  3 days

Secondary Outcomes (4)

• Maximum concentration (Cmax) for PF-04191834 in plasma.

  3 days

• Elimination half-life (t1/2) of PF-04191834

  3 days

• Sheehan suicidality tracking scale (SSTS)

  Screening and last Day of Period 3

• Number of adverse events in patients as a measure of safety and tolerability.

  Throughout the study.

Study Arms (3)

oral single dose dispersion 100mg

ACTIVE COMPARATOR

Subjects receive a single dose of PF-04191834 as a dispersion

Drug: PF-04191834

oral wet milled suspension 100mg

ACTIVE COMPARATOR

Subjects receive a single dose of PF-04191834 as a suspension

Drug: PF-04191834

oral wet milled suspension 300mg

ACTIVE COMPARATOR

Subjects receive a single dose of PF-04191834 as a suspension

Drug: PF-04191834

Interventions

PF-04191834 DRUG

single dose, 100mg, dispersion

oral single dose dispersion 100mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG or clinical laboratory tests.
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg(110 lbs).

You may not qualify if:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
• Clinical evidence of existing hepatic disease or a medical history of such a condition in the last year. Subjects with AST or ALT \>ULN. Subjects with total bilirubin \>ULN (except those with a documented history of Gilbert's Syndrome). Subjects with AST/ALT/total bilirubin \>ULN and \<1.5X ULN may be retested once.
• Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication;
• Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day;
• Females of childbearing potential.
• Subjects with positive responses (score 1) for suicidality on the Sheehan Suicidality Tracking Scale (S-STS) (specifically items 1a, 1b, 3, 4, 5, 6, 7, or 9).

Sponsors & Collaborators

• Pfizer: lead

Related Links

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

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: November 30, 2010
• First Posted: December 23, 2010
• Study Start: December 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: October 16, 2015

Record last verified: 2015-10