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Evaluate the Safety of MN-221 in Subjects With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

MN-221 (Dose Group 1)

MN-221 (Dose Group 2)

MN-221 (Dose Group 3)

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female 40-65 years of age, inclusive;
History of physician-diagnosed COPD treated for ≥ 3 months ;
FEV1 ≥ 30% < 80% and FEV1/FVC ratio < 0.7 at screening;
An increase in FEV1 of at least 12%, over the pre-albuterol FEV1 within 30 minutes after inhalation of albuterol;
Negative urine pregnancy test for all females unless the subject is post-menopausal (≥ 24 months of spontaneous amenorrhea) or surgically sterile (hysterectomy, bilateral ovariectomy or bilateral tubal ligation);
Negative urine drug screen for cocaine, PCP, methamphetamine;
ECG with no evidence of ischemic heart disease or dysrhythmias and otherwise normal or with findings considered not clinically significant at screening;
QTcB and QTcF < 450 msec;
No clinical evidence of active ischemic heart disease as determined by the Investigator; and
Legally effective written informed consent obtained prior to starting any study procedures.

Exclusion Criteria:

Beta agonist and/or anticholinergic via inhaler or intravenously ≤ 6 hours of screening;
Sustained release methylxanthine (e.g. Theophylline) or long acting beta agonists ≤ 24 hours prior to screening;
A diagnosis of clinically significant myocardial or valvular disease; including cardiomyopathy, congestive heart failure, or pulmonary edema;
Acute exacerbation of COPD requiring emergency treatment ≤ 30 days of screening or hospitalization ≤ 90 days of screening;
Antibiotic therapy for respiratory infection ≤ 30 days of screening;
Presence of active respiratory disease such as pneumonia, or acute bronchitis;
History or presence of tachyarrhythmias, with the exception of sinus tachycardia;
Hypokalemia defined as a potassium level ≤ 3.0 mmol/L at screening;
Significant renal, hepatic, endocrine, metabolic, neurologic or other systemic disease;
Uncontrolled hypertension defined as a blood pressure ≥ 170/100 mm Hg at screening;
Pregnant or lactating females;
Participation in another clinical study with an investigational drug within 30 days of screening;
A known allergy to excipients of the MN-221 drug product;
A known allergy to other beta agonists;
Previous exposure to MN-221; or
Use of beta blockers, MAO inhibitors, or tricyclic antidepressants ≤ 2 weeks prior to screening.

Sites / Locations

Dedicated Phase I
California Research Medical Group, INC
Vita Research Solutions & Medical Center, Inc.
Florida Pulmonary Research Institue, LLC
Vince and Associates Clinical Research
Gulf Coast Research, LLC
SNBL CLinical Pharmacology Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MN-221

MN-221 Placebo

Arm Description

Outcomes

Primary Outcome Measures

Adverse events, cardiac and ECG parameters, vital signs, physical exam and clinical laboratory assessments.

Secondary Outcome Measures

Pharmacokinetic parameters of MN-221.

Forced expiratory volume in one second (FEV1).

Full Information

NCT ID

NCT01013142

First Posted

November 10, 2009

Last Updated

May 12, 2015

Sponsor

MediciNova

1. Study Identification

Unique Protocol Identification Number

NCT01013142

Brief Title

Evaluate the Safety of MN-221 in Subjects With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Official Title

A Phase I Randomized, Double-blind, Placebo-controlled Dose Escalation Study to Evaluate the Safety and Efficacy of MN-221 When Administered Intravenously to Subjects With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

November 2009 (undefined)

Primary Completion Date

March 2010 (Actual)

Study Completion Date

March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

MediciNova

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The objective of this clinical study is to determine the safety of intravenous MN-221 compared to placebo when administered in subjects diagnosed with stable moderate to severe COPD.

Detailed Description

This is a randomized, double-blind, placebo-controlled, multi-center dose escalation study in subjects diagnosed with stable moderate to severe COPD. The study will be conducted in approximately 6 Clinical Research Units (CRUs). Subjects with a diagnosis of stable moderate to severe COPD will be screened and must demonstrate an improvement in FEV1 after bronchodilator treatment of at least 12% at Screen Visit 1. The subject's degree of dyspnea will be captured on the British Medical Research Council (MRC) questionnaire, and severity will be determined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) spirometric criteria. Subjects meeting entry criteria at Screen Visit 1 will be asked to return to the CRU for Screen Visit 2 within 14 days of Visit 1. Subjects confirming entry criteria including degree of COPD severity by spirometry at Screen Visit 2 will be randomized to receive either MN-221 or placebo. Serial spirometry will be performed over the 8 hour treatment period after initiation of study drug administration. Subjects will be discharged from the CRU after completing the Hour 8 study procedures and asked to return approximately 24 hours after initiation of study drug for follow up safety assessments including spirometry. A study diary will be provided to each subject upon discharge from the CRU to complete as instructed and return it to the site at the 24 hour Follow-up Visit. There will be three dose levels and each will include approximately 16 subjects randomized to receive either MN-221 or placebo in 3:1 ratio (12 subjects receive MN-221:4 subjects receive placebo). A risk/benefit evaluation will be performed by the study's Safety Review Committee at completion of each dose level prior to escalating to the next dose level. Safety and efficacy will be monitored throughout the treatment period. Blood samples for PK parameters and metabolite identification will be obtained.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

Keywords

COPD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MN-221

Arm Type

Experimental

Arm Title

MN-221 Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

MN-221 (Dose Group 1)

Intervention Description

i.v. infusion of MN-221 (300 mcg) or placebo over 1 hour

Intervention Type

Drug

Intervention Name(s)

MN-221 (Dose Group 2)

Intervention Description

i.v. infusion of MN-221 (600 mcg) or placebo over 1 hour

Intervention Type

Drug

Intervention Name(s)

MN-221 (Dose Group 3)

Intervention Description

i.v. infusion of MN-221 (1,200 mcg) or placebo over 1 hour

Primary Outcome Measure Information:

Title

Adverse events, cardiac and ECG parameters, vital signs, physical exam and clinical laboratory assessments.

Time Frame

Hour 0 (treatment) through Hour 24 (follow-up)

Secondary Outcome Measure Information:

Title

Pharmacokinetic parameters of MN-221.

Time Frame

Pre-dose to Hour 24 post-dose

Title

Forced expiratory volume in one second (FEV1).

Time Frame

Pre-dose to Hour 24 post-dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female 40-65 years of age, inclusive; History of physician-diagnosed COPD treated for ≥ 3 months ; FEV1 ≥ 30% < 80% and FEV1/FVC ratio < 0.7 at screening; An increase in FEV1 of at least 12%, over the pre-albuterol FEV1 within 30 minutes after inhalation of albuterol; Negative urine pregnancy test for all females unless the subject is post-menopausal (≥ 24 months of spontaneous amenorrhea) or surgically sterile (hysterectomy, bilateral ovariectomy or bilateral tubal ligation); Negative urine drug screen for cocaine, PCP, methamphetamine; ECG with no evidence of ischemic heart disease or dysrhythmias and otherwise normal or with findings considered not clinically significant at screening; QTcB and QTcF < 450 msec; No clinical evidence of active ischemic heart disease as determined by the Investigator; and Legally effective written informed consent obtained prior to starting any study procedures. Exclusion Criteria: Beta agonist and/or anticholinergic via inhaler or intravenously ≤ 6 hours of screening; Sustained release methylxanthine (e.g. Theophylline) or long acting beta agonists ≤ 24 hours prior to screening; A diagnosis of clinically significant myocardial or valvular disease; including cardiomyopathy, congestive heart failure, or pulmonary edema; Acute exacerbation of COPD requiring emergency treatment ≤ 30 days of screening or hospitalization ≤ 90 days of screening; Antibiotic therapy for respiratory infection ≤ 30 days of screening; Presence of active respiratory disease such as pneumonia, or acute bronchitis; History or presence of tachyarrhythmias, with the exception of sinus tachycardia; Hypokalemia defined as a potassium level ≤ 3.0 mmol/L at screening; Significant renal, hepatic, endocrine, metabolic, neurologic or other systemic disease; Uncontrolled hypertension defined as a blood pressure ≥ 170/100 mm Hg at screening; Pregnant or lactating females; Participation in another clinical study with an investigational drug within 30 days of screening; A known allergy to excipients of the MN-221 drug product; A known allergy to other beta agonists; Previous exposure to MN-221; or Use of beta blockers, MAO inhibitors, or tricyclic antidepressants ≤ 2 weeks prior to screening.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alan W Dunton, MD

Organizational Affiliation

MediciNova

Official's Role

Study Director

Facility Information:

Facility Name

Dedicated Phase I

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85013

Country

United States

Facility Name

California Research Medical Group, INC

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Facility Name

Vita Research Solutions & Medical Center, Inc.

City

Tamarac

State/Province

Florida

ZIP/Postal Code

33319

Country

United States

Facility Name

Florida Pulmonary Research Institue, LLC

City

Winter Park

State/Province

Florida

ZIP/Postal Code

32789

Country

United States

Facility Name

Vince and Associates Clinical Research

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66211

Country

United States

Facility Name

Gulf Coast Research, LLC

City

Lafayette

State/Province

Louisiana

ZIP/Postal Code

70503

Country

United States

Facility Name

SNBL CLinical Pharmacology Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Evaluate the Safety of MN-221 in Subjects With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

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