Single Day and Multiple Day Ascending Dose Study of ARRY-371797 in Healthy Volunteers - Full Text View

Sponsored by:	Array BioPharma
Information provided by:	Array BioPharma
ClinicalTrials.gov Identifier:	NCT00790049

Purpose

Randomized, double-blind, placebo-controlled study to evaluate safety and pharmacokinetics of ARRY-371797 given to healthy volunteers

Condition	Intervention	Phase
Healthy	Drug: ARRY-371797 Drug: Placebo	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study
Official 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

Further study details as provided by Array BioPharma:

Primary Outcome Measures:

Assess safety through close monitoring of adverse events, vital signs, and ECGs. [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
Assess the pharmacokinetics (PK) of ARRY-371797 in plasma in healthy volunteers [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Possible identification of additional metabolites of ARRY-371797 [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	October 2008
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
ARRY-371797: Experimental ARRY-371797	Drug: ARRY-371797 Drug in capsule
Placebo: Placebo Comparator Placebo	Drug: Placebo Capsule

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

A personally signed and dated informed consent document
Healthy male or female subject of non-childbearing potential between the ages of 18 and 60 years, inclusive. Healthy is defined as no clinically significant abnormalities identified by a detailed medical history, complete physical examination including vital signs and temperature, 12-lead ECG, and clinical laboratory tests. Non-childbearing potential is defined as amenorrheic for at least 2 years and a serum follicle stimulating hormone (FSH) level > 30 IU/L, or documented bilateral oophorectomy and/or hysterectomy
Body mass index (BMI) of 18 to 35 kg/m2 and a total body weight > 50 kg (110 lbs) and < 113 kg (250 lbs)
Subject who is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

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)
A positive test for drugs or alcohol
Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day
Treatment with an investigational drug within 30 days preceding the first dose of study medication
12-lead ECG , demonstrating QTcB or QTcF > 450 msec at screening and prior to randomization on Day 1, or history/evidence of long QT syndrome
Use of prescription or nonprescription drugs, vitamins, grapefruit juice, and dietary or herbal supplements within 14 days prior to a dose of study drug. As an exception, acetaminophen may be used at doses < 1 g/day until 24 hours prior to dosing on Day 1
Blood donation of > 1 pint (500 mL) within 30 days prior to dosing
Screening and Day -1 liver function tests (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] > 1.5 x upper limit of normal (ULN) or creatinine phosphokinase (CPK) > 1.5 x ULN
Evidence of hepatitis B or C, or human immunodeficiency virus (HIV) infection upon serological testing
Evidence of active infection or febrile illness within 7 days of dosing (e.g., bronchopulmonary, urinary, or gastrointestinal)
Subjects who have previously received ARRY-371797

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00790049

Locations

United States, Texas
PPD Phase I Clinic	Recruiting
Austin, Texas, United States, 78744
Contact: Sarah Adams 512-447-2985 sarah.adams@austin.ppdi.com
Principal Investigator: Matthew Medlock, MD

Sponsors and Collaborators

Array BioPharma

More Information

Responsible Party:	Array BioPharma Inc. ( Lisa Anderson, Clinical Study Manager )
Study ID Numbers:	ARRAY-797-107
Study First Received:	November 10, 2008
Last Updated:	November 11, 2008
ClinicalTrials.gov Identifier:	NCT00790049
Health Authority:	United States: Food and Drug Administration

Keywords provided by Array BioPharma:

Safety

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 16, 2009