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Completed

NCT Number: NCT00790049

A Safety Study of ARRY-371797 in Healthy Subjects

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.

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PPD Phase I Clinic

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

  • 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.

Treatment and study plan

ARRY-371797, p38 inhibitor; oral

Drug

single dose and multiple dose, escalating

Placebo; oral

Drug

matching placebo

Primary outcomes

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

    Time frame: Duration of study

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

    Time frame: Duration of study

Sponsors and collaborators

Lead sponsor

Array Biopharma, now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Single Day And Multiple Day Ascending Dose Study To Evaluate The Safety And Pharmacokinetics Of Orally Administered ARRY-371797 In Healthy Volunteers

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 13, 2008
Registry last updated
May 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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