A Multiple Dose Study To Determine Safety, Tolerability, and Pharmacokinetics Of PF-04634817 In Healthy Adult Subjects

June 7, 2011 updated by: Pfizer

A Double Blind, 3rd Party Open, Placebo Controlled, Dose Escalating, Parallel Study To Investigate The Safety, Toleration And Pharmacokinetics Of Multiple Oral Doses Of PF-04634817 In Healthy Volunteers

The goals of this study are to evaluate the safety and tolerability of multiple ascending doses of PF-04634817 administered orally to healthy adult subjects. In additional, the plasma and urinary pharmacokinetics of multiple ascending doses of PF-04634817 administered orally to healthy adult subjects will be evaluated. Finally, the effect of multiple doses of PF-04634817 on circulating monocytes will be explored.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy male and female (of non-childbearing potential) subjects between the ages of 18 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).

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease;
  • 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;
  • Nursing females;
  • Females of childbearing potential.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cohort 1 (N=10)
Placebo-controlled, multiple doses of PF-04634817 at 3 mg per day for 14 days. (2 placebo: 8 active)
Drug: PF-04634817
Oral solution of PF-04634817 at 3 mg will be given once daily for 14 days.
Drug: PF-04634817
Oral solution of PF-04634817 at 30 mg will be given once daily for 14 days.
Drug: PF-04634817
Oral solution of PF-04634817 at 100 mg will be given once daily for 14 days.
Drug: PF-04634817
Oral solution of PF-04634817 at 300 mg will be given once daily for 14 days.
Drug: PF-04634817
Cohort will only be dosed if necessary. Dose selected for this cohort may be a repeat of a previous cohort or intermediate dose not to exceed 300 mg.
EXPERIMENTAL: Cohort 2 (N=10)
Placebo-controlled, multiple doses of PF-04634817 at 3 mg per day for 14 days. (2 placebo: 8 active)
Drug: PF-04634817
Oral solution of PF-04634817 at 3 mg will be given once daily for 14 days.
Drug: PF-04634817
Oral solution of PF-04634817 at 30 mg will be given once daily for 14 days.
Drug: PF-04634817
Oral solution of PF-04634817 at 100 mg will be given once daily for 14 days.
Drug: PF-04634817
Oral solution of PF-04634817 at 300 mg will be given once daily for 14 days.
Drug: PF-04634817
Cohort will only be dosed if necessary. Dose selected for this cohort may be a repeat of a previous cohort or intermediate dose not to exceed 300 mg.
EXPERIMENTAL: Cohort 3 (N=10)
Placebo-controlled, multiple doses of PF-04634817 at 30 mg per day for 14 days. (2 placebo: 8 active)
Drug: PF-04634817
Oral solution of PF-04634817 at 3 mg will be given once daily for 14 days.
Drug: PF-04634817
Oral solution of PF-04634817 at 30 mg will be given once daily for 14 days.
Drug: PF-04634817
Oral solution of PF-04634817 at 100 mg will be given once daily for 14 days.
Drug: PF-04634817
Oral solution of PF-04634817 at 300 mg will be given once daily for 14 days.
Drug: PF-04634817
Cohort will only be dosed if necessary. Dose selected for this cohort may be a repeat of a previous cohort or intermediate dose not to exceed 300 mg.
EXPERIMENTAL: Cohort 4 (N=10)
Placebo-controlled, multiple doses of PF-04634817 at 100 mg per day for 14 days. (2 placebo: 8 active)
Drug: PF-04634817
Oral solution of PF-04634817 at 3 mg will be given once daily for 14 days.
Drug: PF-04634817
Oral solution of PF-04634817 at 30 mg will be given once daily for 14 days.
Drug: PF-04634817
Oral solution of PF-04634817 at 100 mg will be given once daily for 14 days.
Drug: PF-04634817
Oral solution of PF-04634817 at 300 mg will be given once daily for 14 days.
Drug: PF-04634817
Cohort will only be dosed if necessary. Dose selected for this cohort may be a repeat of a previous cohort or intermediate dose not to exceed 300 mg.
EXPERIMENTAL: Cohort 5 (N=10)
Placebo-controlled, multiple doses of PF-04634817 at 300 mg per day for 14 days. (2 placebo: 8 active)
Drug: PF-04634817
Oral solution of PF-04634817 at 3 mg will be given once daily for 14 days.
Drug: PF-04634817
Oral solution of PF-04634817 at 30 mg will be given once daily for 14 days.
Drug: PF-04634817
Oral solution of PF-04634817 at 100 mg will be given once daily for 14 days.
Drug: PF-04634817
Oral solution of PF-04634817 at 300 mg will be given once daily for 14 days.
Drug: PF-04634817
Cohort will only be dosed if necessary. Dose selected for this cohort may be a repeat of a previous cohort or intermediate dose not to exceed 300 mg.
EXPERIMENTAL: Cohort 6 (N=10) Optional cohort
Placebo-controlled, multiple doses of PF-04634817 up to 300 mg per day for 14 days. (2 placebo: 8 active)
Drug: PF-04634817
Oral solution of PF-04634817 at 3 mg will be given once daily for 14 days.
Drug: PF-04634817
Oral solution of PF-04634817 at 30 mg will be given once daily for 14 days.
Drug: PF-04634817
Oral solution of PF-04634817 at 100 mg will be given once daily for 14 days.
Drug: PF-04634817
Oral solution of PF-04634817 at 300 mg will be given once daily for 14 days.
Drug: PF-04634817
Cohort will only be dosed if necessary. Dose selected for this cohort may be a repeat of a previous cohort or intermediate dose not to exceed 300 mg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events, supine and standing vital sign measurements, 12-lead ECGs, blood and urine safety tests.
Time Frame: 14 days
14 days
Plasma PK Day 1: Cmax, Tmax, AUClast, AUCtau at all dose levels. Plasma PK Day 14: Cmax, Tmax, AUClast, AUCtau, AUCinf, t½, CL/F and Vss/F at all dose levels.
Time Frame: 14 days
14 days
AUCtau (Day 14) vs. AUCtau (Day 1) - estimate of accumulation ratio; Cmax (Day 14) vs. Cmax (Day 1); Tmax (Day 14) vs. Tmax (Day 1).
Time Frame: 14 days
14 days
Urinary PK: Aet (amount excreted in urine); Aet% at all doses of PF-04634817 where t = 24 hours on Day 1 and 14; CLr at all doses on Day 14.
Time Frame: 14 days
14 days
Pharmacodynamic: MCP-1 change from baseline.
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacodynamic: p-ERK Inhibition in human monocytes: percent inhibition of monocyte p-ERK activity relative to the pre-dose baseline value
Time Frame: 14 days
14 days
MIP-1β stimulated CCR5 receptor internalization: percent inhibition of internalization relative to the pre-dose baseline value
Time Frame: 14 days
14 days
Absolute and percent change in circulating monocytes; Absolute and percent change in CD14+CD16+ monocytes.
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ACTUAL)

October 1, 2010

Study Completion (ACTUAL)

October 1, 2010

Study Registration Dates

First Submitted

June 8, 2010

First Submitted That Met QC Criteria

June 8, 2010

First Posted (ESTIMATE)

June 9, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 8, 2011

Last Update Submitted That Met QC Criteria

June 7, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • B1261003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on PF-04634817

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe