NCT00790049

Brief Summary

This is a Phase 1 study, involving both 1-day and 8-day dosing periods, designed to test the safety of investigational study drug ARRY-371797 in healthy subjects. Approximately 48 healthy subjects from the US will be enrolled in this study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Oct 2008

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

October 31, 2008

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 13, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2009

Completed
Last Updated

May 5, 2022

Status Verified

April 1, 2022

Enrollment Period

3 months

First QC Date

November 10, 2008

Last Update Submit

April 29, 2022

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms.

    Duration of study

  • Characterize the pharmacokinetics (PK) of the study drug and a metabolite in terms of plasma concentrations.

    Duration of study

Study Arms (2)

ARRY-371797

EXPERIMENTAL
Drug: ARRY-371797, p38 inhibitor; oral

Placebo

PLACEBO COMPARATOR
Drug: Placebo; oral

Interventions

ARRY-371797, p38 inhibitor; oralDRUG

single dose and multiple dose, escalating

ARRY-371797
Placebo; oralDRUG

matching placebo

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male or female between the ages of 18 and 60 years.
  • Females must be of nonchildbearing potential.
  • Body weight \> 50 kg (110 lbs) and \< 113 kg (250 lbs).
  • Additional criteria exist.

You may not qualify if:

  • A positive test for drugs or alcohol.
  • Use of prescription or nonprescription drugs, herbal or dietary supplements, vitamins, or grapefruit juice within 14 days prior to first dose of study drug.
  • Additional criteria exist.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PPD Phase I Clinic

Austin, Texas, 78744, United States

Location

MeSH Terms

Interventions

ARRY-371797

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2008

First Posted

November 13, 2008

Study Start

October 31, 2008

Primary Completion

January 21, 2009

Study Completion

January 21, 2009

Last Updated

May 5, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Locations

US(1)