NCT01626976

Brief Summary

This is the first-in-human study for an oral investigational compound, PF-06282999, in order to assess its safety, tolerability and pharmacokinetics in humans across a wide range of dose levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jun 2012

Typical duration 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

First Submitted

Initial submission to the registry

May 30, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 25, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

March 13, 2013

Status Verified

March 1, 2013

Enrollment Period

9 months

First QC Date

May 30, 2012

Last Update Submit

March 12, 2013

Conditions

Healthy

Keywords

safetytolerabilitypharmacokineticsoralsingle ascending doseplacebo-controlledhealthy subjects

Outcome Measures

Primary Outcomes (12)

  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf]

    0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose

  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

    0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose

  • Area Under the Curve From Time Zero to 24 hour [AUC24]

    0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24 hours post-dose

  • Maximum Observed Plasma Concentration (Cmax)

    0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose

  • Time to Reach Maximum Observed Plasma Concentration (Tmax)

    0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose

  • Apparent Oral Clearance (CL/F)

    0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose

  • Plasma Decay Half-Life (t1/2)

    0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose

  • Apparent Volume of Distribution (Vz/F)

    0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose

  • Amount of Unchanged Drug Excretion in Urine from Zero to 24 hours (Ae24)

    0 to 24 hours post-dose

  • Percent of Dose Excreted in Urine as Unchanged Drug from Zero to 24 hours (Ae24%)

    0 to 24 hours post-dose

  • Renal Clearance (CLr)

    0 to 24 hours post-dose

  • Oral temperature

    0, 1, 2, 4, 8, 12,16, 24, 48 hours post-dose

Study Arms (5)

Cohort 1

EXPERIMENTAL
Drug: PF-06282999Drug: Placebo

Cohort 2

EXPERIMENTAL
Drug: PF-06282999Drug: Placebo

Cohort 3

EXPERIMENTAL
Drug: PF-06282999Drug: Placebo

Cohort 4

EXPERIMENTAL
Drug: PF-06282999Drug: Placebo

Cohort 5

EXPERIMENTAL
Drug: PF-06282999Drug: Placebo

Interventions

PF-06282999DRUG

Solution, doses range from 20 to 200 mg, single dose

Cohort 1
PlaceboDRUG

Solution, single dose

Cohort 1

Eligibility Criteria

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

You may qualify if:

  • Healthy male and/or female subjects 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 and clinical laboratory tests).
  • Women must be of non-childbearing potential.
  • 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 clinically significant drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. Herbal supplements and hormone replacement therapy must be discontinued 28 days prior to the first dose of study medication. As an exception, acetaminophen/paracetamol may be used at doses of ≤1 g/day. Limited use of non-prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Brussels, B-1070, Belgium

Location

Related Links

MeSH Terms

Interventions

2-(6-(5-chloro-2-methoxyphenyl)-4-oxo-2-thioxo-3,4-dihydropyrimidin-1(2H)-yl)acetamide

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
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2012

First Posted

June 25, 2012

Study Start

June 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

March 13, 2013

Record last verified: 2013-03

Locations

BE(1)