NCT01147406

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of N6022 in healthy subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Aug 2010

Longer than P75 for phase_1 healthy

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

First Submitted

Initial submission to the registry

June 14, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 22, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

March 7, 2014

Completed
Last Updated

March 7, 2014

Status Verified

January 1, 2014

Enrollment Period

10 months

First QC Date

June 14, 2010

Results QC Date

November 26, 2013

Last Update Submit

January 21, 2014

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Safety and Tolerability of a Single Ascending Doses of Intravenous N6022 in Healthy Volunteers

    Safety variables - number of adverse events reported during study, changes in vital signs, physical examination findings, telemetry alerts, 12-lead ECG changes, infusion site reactions, O2 saturation changes, and clinical laboratory assessment changes between subjects receiving N6022 versus placebo.

    7 Days

Secondary Outcomes (1)

  • Maximum N6022 and Metabolite Concentrations in Plasma Within 24 Hours of End of Administration

    24 hours

Study Arms (2)

Active

EXPERIMENTAL

N6022

Drug: N6022

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

N6022DRUG

This is an injectible formulation which will be given at 5, 15 \& 45 mg over 1, 3 and 9 minutes respectively, in single ascending doses.

Active
PlaceboDRUG

This will be 0.9% normal saline given over 1, 3, or 9 minutes IV bolus.

Also known as: N6022
Placebo

Eligibility Criteria

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

You may qualify if:

  • Subject is healthy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parexel Early Phase Unit

Baltimore, Maryland, 21225, United States

Location

MeSH Terms

Interventions

N6022

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

June 14, 2010

First Posted

June 22, 2010

Study Start

August 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

March 7, 2014

Results First Posted

March 7, 2014

Record last verified: 2014-01

Locations

US(1)