NCT01339897

Brief Summary

This Phase 1 study will evaluate multiple doses across a range that has been found to be effective in mouse models of asthma and safe in one Phase 1 clinical trial. It is intended to provide evidence of the tolerability of multiple doses as well as provide information on the Pharmacokinetic (PK) and metabolism of N6022 in humans.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

April 19, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 21, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

January 19, 2015

Completed
Last Updated

January 19, 2015

Status Verified

January 1, 2015

Enrollment Period

4 months

First QC Date

April 19, 2011

Results QC Date

November 26, 2013

Last Update Submit

January 15, 2015

Conditions

Healthy

Keywords

N6022, GSNORi

Outcome Measures

Primary Outcomes (1)

  • Safety of Escalating Multiple Doses of N6022 in Healthy Subjects

    Safety variables (adverse events, vital signs, physical examination, telemetry, 12-lead ECG, infusion site reactions, O2 saturation, and clinical laboratory assessments)

    Over 7 days

Secondary Outcomes (4)

  • Pharmacokinetics of N6022

    Day 1, 24 hours

  • Pharmacokinetics of N6022 Over 7 Days

    Day 7, 24 hours

  • Pharmacokinetics of N6022 on Study Day 1

    Day 1, 24 hours

  • Pharmacokinetics of N6022 Cmax Values on Study Day 7

    Day 7, 24 hours

Study Arms (4)

5 mg/N6022

ACTIVE COMPARATOR

Injectable formulation, given at doses per cohort of 5 mg given QD each day over 7 days.

Drug: 5 mg/N6022

Placebo

PLACEBO COMPARATOR

Injectable formulation normal saline

Drug: Placebo

10mg/N6022

ACTIVE COMPARATOR

Injectable formulation, given at doses of 10 mg given QD each day over 7 days.

Drug: 10mg/N6022

20mg/N6022

ACTIVE COMPARATOR

Injectable formulation, given at doses per cohort of 20 mg given QD each day over 7 days.

Drug: 20mg/N6022

Interventions

5 mg/N6022DRUG

Intravenous formulation, given at doses of 5 mg once each day over 7 days.

Also known as: N6022, GSNOR Inhibitor
5 mg/N6022
PlaceboDRUG

Same administration procedures as active

Also known as: Normal Saline
Placebo
10mg/N6022DRUG

Intravenous formulation given at doses of 10 mg once each day over 7 days.

Also known as: N6022, GSNOR Inhibitor
10mg/N6022
20mg/N6022DRUG

Intravenous formulation given at doses of 20 mg once each day over 7 days.

Also known as: N6022, GSNOR Inhibitor
20mg/N6022

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subject is healthy, determined by pre-study medical evaluation (medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations
  • Subject is a non-smoker (or other nicotine user) as determined by history (no nicotine use over the past year) and a negative urine cotinine test at screening and Day 1.
  • Subject has a body weight \> 50 kg and BMI between 19.5 and 29.5 kg/m2, inclusive, at screening.
  • Subject has systolic BP \> 90 mmHg and diastolic BP \> 50 mmHg at screening or Day-1.

You may not qualify if:

  • Subject has clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s) as determined by the investigator or designee.
  • Subject is a current alcohol abuser and/or has a history of illicit drug abuse within six months of entry.
  • Subject has donated blood (\> 500 mL) or blood products within 56 days prior to Day -1.
  • Subject has a history of bleeding disorders (i.e., severe hemorrhage, melena, rectal bleeding, nosebleeds, bruising, etc.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parexel International

Baltimore, Maryland, 21225, United States

Location

MeSH Terms

Interventions

N6022Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
Janice M Troha
Organization
N30 Pharmaceuticals Inc.
janice.troha@n30pharma.com
720-945-7714

Study Officials

  • Ronald Goldwater, MDCM, MSc(A)

    Parexel

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

April 19, 2011

First Posted

April 21, 2011

Study Start

April 1, 2011

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

January 19, 2015

Results First Posted

January 19, 2015

Record last verified: 2015-01

Locations

US(1)