A Safety Study of ARRY-300 in Healthy Subjects

Sponsor

Array Biopharma, now a wholly owned subsidiary of Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00828165

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Phase 1 study, involving a 1-day dosing period (up to 3 dosing periods per subject), designed to test the safety of investigational study drug ARRY-300 in healthy subjects. Approximately 12 healthy subjects from the US will be enrolled in this study.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: ARRY-300, MEK inhibitor; oral Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Other

Study Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Apr 1, 2009

Actual Study Completion Date :

Apr 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ARRY-300	Drug: ARRY-300, MEK inhibitor; oral single dose, escalating
Placebo Comparator: Placebo Placebo	Drug: Placebo matching placebo

Arm

Intervention/Treatment

Experimental: ARRY-300

Drug: ARRY-300, MEK inhibitor; oral

single dose, escalating

Placebo Comparator: Placebo

Placebo

Drug: Placebo

matching placebo

Outcome Measures

Primary Outcome Measures

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 metabolites in terms of plasma concentrations. [Following a single dose]

Secondary Outcome Measures

Characterize the pharmacodynamic (PD) activity of the study drug on biomarkers. [Duration of study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Key Inclusion Criteria:

Healthy male or female (females must be of non-childbearing potential) between the ages of 18 and 50 years, inclusive.
Body mass index (BMI) of 18 kg/m2 to 35 kg/m2; and a total body weight > 50 kg (110 lbs) and < 113 kg (280 lbs).
Additional criteria exist.

Key Exclusion Criteria:

Evidence or history of clinically significant hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, dermatologic, or allergic disease (including drug allergies that are clinically significant and not remote, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
A condition possibly affecting drug absorption (e.g., gastrectomy).
Women who are pregnant or breastfeeding.
A positive test for drugs or alcohol.
Use of tobacco- or nicotine-containing products in excess of 5 cigarettes per day, or daily use of pipe, cigar, chewing tobacco or nicotine gum or patches.
Treatment with an investigational drug within 30 days prior to first dose of study drug.
Use of prescription or nonprescription drugs, vitamins, grapefruit juice, and dietary or herbal supplements within 14 days prior to the first dose of study drug. As exceptions, acetaminophen may be used at doses of ≤ 1 g/day or ibuprofen may be used at doses of ≤ 800 mg/day until 24 hours prior to first dose of study drug.
Blood donation of ≥ 1 pint within 30 days prior to first dose of study drug.
Evidence of hepatitis B or C, or human immunodeficiency virus (HIV) infection upon serological testing.
Additional criteria exist.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PPD Development, LP	Austin	Texas	United States	78744

Sponsors and Collaborators

Array Biopharma, now a wholly owned subsidiary of Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Array Biopharma, now a wholly owned subsidiary of Pfizer

ClinicalTrials.gov Identifier:

NCT00828165

Other Study ID Numbers:

ARRAY-300-101

First Posted:

Jan 23, 2009

Last Update Posted:

Oct 6, 2020

Last Verified:

Oct 1, 2020

Study Results

No Results Posted as of Oct 6, 2020