A Safety and Tolerability Study of 42037788 (Referred to as CNTO 0007) Compared With Placebo in Patients Who Have Experienced Ischemic Cerebral Infarction (Also Known as Stroke)

NCT01273467 | Completed Phase 1 DMC

• 2 other identifiers: CR01651042037788
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of 42037788 (CNTO 0007) in patients who have suffered a stroke. The study is not designed to establish efficacy, although preliminary explorations will be conducted.

Conditions

Stroke; Ischemia; Infarction

Keywords

Ischemic Cerebral Infarction; Stroke; CNTO0007; 42037788

Outcome Measures

Primary Outcomes (4)

• The number and type of adverse events reported

  Up to 90 days following study drug administration

• Changes in clinical laboratory test values

  Up to 90 days following study drug administration

• Changes in vital signs measurements

  Up to 90 days following study drug administration

• Changes in electrocardiograms

  Up to 90 days following study drug administration

Secondary Outcomes (1)

• Blood concentration of CNTO 0007

  At protocol-specified time points on Day 1

Study Arms (2)

001

EXPERIMENTAL

CNTO 0007 or placebo (Stage A) a single IV infusion of a selected dose of CNTO 0007 or placebo administered IV within 1-5 days (depending on cohort) after stroke (first cohort of patients will receive the lowest dose of CNTO 0007 or placebo and each subsequent group will be administered a higher dose (to be determined)

Drug: CNTO 0007 or placebo (Stage A)

002

EXPERIMENTAL

CNTO 0007 or placebo (Stage B) a single IV infusion of the MTD of CNTO 0007 or placebo administered IV within a specified number of days after stroke

Drug: CNTO 0007 or placebo (Stage B)

Interventions

CNTO 0007 or placebo (Stage A) DRUG

a single IV infusion of a selected dose of CNTO 0007 or placebo administered IV within 1-5 days (depending on cohort) after stroke (first cohort of patients will receive the lowest dose of CNTO 0007 or placebo and each subsequent group will be administered a higher dose (to be determined)

001

CNTO 0007 or placebo (Stage B) DRUG

a single IV infusion of the MTD of CNTO 0007 or placebo administered IV within a specified number of days after stroke

002

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients who have suffered an ischemic stroke, as defined by the protocol (If a woman, must be postmenopausal, defined as having no menses for the 18 months before study start. Premenopausal, surgically-sterilized women must have a negative serum beta human chorionic gonadotropin pregnancy test at screening before CNTO 0007 or placebo administration)
• Patients must be able to remain as inpatients for at least 3 days post-infusion for intensive safety monitoring
• Patients must receive standard post-stroke care before the infusion begins and after treatment with experimental product, including but not limited to appropriate secondary prevention measure such as blood pressure and cholesterol control and antiplatelet agents, unless contraindicated
• Patient must have no clinical evidence of worsening stroke in the last 24 hours prior to the start of the infusion of study treatment
• Patients must have general medical condition consistent with expected survival for at least 1 year.

You may not qualify if:

• Presence or history of any clinically significant disease, medical condition, or treatment intervention as determined by the Investigator
• Presence or history of alcohol or drug abuse as defined by the 4th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) within 1 year before the screening phase.

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (2)

Unknown Facility

Portland, Oregon, United States

Location

Unknown Facility

Houston, Texas, United States

Location

MeSH Terms

Conditions

Stroke; Ischemia; Infarction

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Janssen Research & Development, LLC C. Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2011
• First Posted: January 10, 2011
• Study Start: December 1, 2010
• Study Completion: July 1, 2013
• Last Updated: March 18, 2014

Record last verified: 2014-03

Locations

US (2)