NCT01140672

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jun 2010

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

June 1, 2010

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 9, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

June 8, 2011

Status Verified

June 1, 2011

Enrollment Period

4 months

First QC Date

June 8, 2010

Last Update Submit

June 7, 2011

Conditions

Healthy

Keywords

Healthy volunteerspharmacokineticssafetytolerabilitymultiple dosingDiabetic Nephropathies

Outcome Measures

Primary Outcomes (5)

  • Adverse events, supine and standing vital sign measurements, 12-lead ECGs, blood and urine safety tests.

    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.

    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).

    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.

    14 days

  • Pharmacodynamic: MCP-1 change from baseline.

    14 days

Secondary Outcomes (3)

  • Pharmacodynamic: p-ERK Inhibition in human monocytes: percent inhibition of monocyte p-ERK activity relative to the pre-dose baseline value

    14 days

  • MIP-1β stimulated CCR5 receptor internalization: percent inhibition of internalization relative to the pre-dose baseline value

    14 days

  • Absolute and percent change in circulating monocytes; Absolute and percent change in CD14+CD16+ monocytes.

    14 days

Study Arms (6)

Cohort 1 (N=10)

EXPERIMENTAL

Placebo-controlled, multiple doses of PF-04634817 at 3 mg per day for 14 days. (2 placebo: 8 active)

Drug: PF-04634817

Cohort 2 (N=10)

EXPERIMENTAL

Placebo-controlled, multiple doses of PF-04634817 at 3 mg per day for 14 days. (2 placebo: 8 active)

Drug: PF-04634817

Cohort 3 (N=10)

EXPERIMENTAL

Placebo-controlled, multiple doses of PF-04634817 at 30 mg per day for 14 days. (2 placebo: 8 active)

Drug: PF-04634817

Cohort 4 (N=10)

EXPERIMENTAL

Placebo-controlled, multiple doses of PF-04634817 at 100 mg per day for 14 days. (2 placebo: 8 active)

Drug: PF-04634817

Cohort 5 (N=10)

EXPERIMENTAL

Placebo-controlled, multiple doses of PF-04634817 at 300 mg per day for 14 days. (2 placebo: 8 active)

Drug: PF-04634817

Cohort 6 (N=10) Optional cohort

EXPERIMENTAL

Placebo-controlled, multiple doses of PF-04634817 up to 300 mg per day for 14 days. (2 placebo: 8 active)

Drug: PF-04634817

Interventions

PF-04634817DRUG

Oral solution of PF-04634817 at 3 mg will be given once daily for 14 days.

Cohort 1 (N=10)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Related Links

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

PF-04634817

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

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

June 8, 2010

First Posted

June 9, 2010

Study Start

June 1, 2010

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

June 8, 2011

Record last verified: 2011-06

Locations

US(1)