A Study In Healthy People To Investigate The Safety, Toleration And Time Course Of Blood Concentrations Of Multiple Doses Of PF-03654764, Given By Mouth

NCT00989391 | Completed Phase 1

• 1 other identifier: B0711002
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study in heathy people is to investigate the safety, toleration and time course of PF-03654764 in the blood, following multiple doses given once or twice daily by mouth for 10 days.

Conditions

Healthy

Keywords

Phase 1 multiple dose safety toleration pharmacokinetic

Outcome Measures

Primary Outcomes (1)

• safety & toleration: Adverse events, vital signs, 12 lead ECG, blood and urine safety tests, suicidality assessment using the Suicidality Tracking Scale (STS) and physical examination.

  10 days

Secondary Outcomes (2)

• Plasma pharmacokinetics: Cmax, Tmax, AUCtau, t½, AUCtau (Day 10)/AUCtau (Day 1), CL/F

  10 days

• Urine pharmacokinetics: Ae24 & Ae24% (for once daily doses) or Ae12 & Ae12% (for twice daily dose) on Day 10, CLR

  10 days

Study Arms (3)

Cohort 1

EXPERIMENTAL

Subjects will be assigned to receive either PF-03654764 or placebo.

Drug: PF-03654764; Drug: placebo

Cohort 2

EXPERIMENTAL

Subjects will be assigned to receive either PF-03654764 or placebo.

Drug: PF-03654764; Drug: placebo

Cohort 3

EXPERIMENTAL

Subjects will be assigned to receive either PF-03654764 or placebo.

Drug: PF-03654764; Drug: placebo

Interventions

PF-03654764 DRUG

5mg orally once daily for 10 days. After satisfactory review of the available safety, toleration and PK data, progression to the next dose will occur if the last dose was well tolerated. If the previous dose was not well tolerated, after review of the safety data, and discussion between the Pfizer Study Team and the Investigator, the same dose may be given again, a lower dose within the tolerated dose range may be given, or the study may be stopped. The dose increments will be based on emerging safety and toleration data, as well as plasma exposure estimates and forward predictions of PK. Nominal administered doses will not exceed 24 mg per day.

Cohort 1

placebo DRUG

orally once daily for 10 days. After satisfactory review of the available safety, toleration and PK data, progression to the next dose will occur if the last dose was well tolerated. If the previous dose was not well tolerated, after review of the safety data, and discussion between the Pfizer Study Team and the Investigator, the same dose may be given again, a lower dose within the tolerated dose range may be given, or the study may be stopped. The dose increments will be based on emerging safety and toleration data, as well as plasma exposure estimates and forward predictions of PK. Nominal administered doses will not exceed 24 mg per day.

Cohort 1

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects. (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 and clinical laboratory tests).

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 time of dosing).
• A positive urine drug screen.
• Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Singapore, 188770, Singapore

Location

MeSH Terms

Interventions

3-fluoro-3-(3-fluoro-4-(pyrrolidin-1-ylmethyl)phenyl)-N-(2-methylpropyl)cyclobutanecarboxamide

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 2, 2009
• First Posted: October 5, 2009
• Study Start: October 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 16, 2009

Record last verified: 2009-12

Locations

SG (1)