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Safety and Tolerability Study of N6022 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01147406
Recruitment Status : Completed
First Posted : June 22, 2010
Results First Posted : March 7, 2014
Last Update Posted : March 7, 2014
Sponsor:
Information provided by (Responsible Party):
Nivalis Therapeutics, Inc.

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety and tolerability of N6022 in healthy subjects.

Condition or disease Intervention/treatment Phase
Healthy Drug: N6022 Drug: Placebo Phase 1

Detailed Description:
This is a single dose escalation, first-time-in-human study with three ascending cohorts. Eligible subjects will receive a single dose of investigational medicinal product or placebo on Day 1 and will be followed for safety, PK, and PD for 72 hours post dose. Follow-up visits on Day 4 and Day 7 for the end-of-study safety. Participation of an individual subject may last up to 36 days from the time of screening until the end-of-study follow-up visit. Each cohort will enroll a sentinel pair (1:1 randomized to active: placebo). These subjects will be followed for 48 hours postdose and safety data reviewed before the remaining subjects in the cohort receive IMP. A Safety Monitoring Committee will review the seven-day safety data in each cohort before proceeding to the next ascending dose cohort, according to the stopping rules outlined in the protocol.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effect of N6022 in Healthy Subjects
Study Start Date : August 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011
Arms and Interventions
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Arm Intervention/treatment
Experimental: Active
N6022
 Drug: N6022
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.
Placebo Comparator: Placebo
Placebo
 Drug: Placebo
This will be 0.9% normal saline given over 1, 3, or 9 minutes IV bolus.
Other Name: N6022


Outcome Measures
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Primary Outcome Measures :
  1. Safety and Tolerability of a Single Ascending Doses of Intravenous N6022 in Healthy Volunteers [ Time Frame: 7 Days ]
    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.


Secondary Outcome Measures :
  1. Maximum N6022 and Metabolite Concentrations in Plasma Within 24 Hours of End of Administration [ Time Frame: 24 hours ]
    Concentrations of N6022 and metabolite [N61149)], collected on Days 1 and 7; predose, end of infusion, and at 10 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 16, and 24 hours post-dose (the 24 hour postdose collected prior to the start of infusion on Day 2).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion:

  • Subject is healthy

Exclusion:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01147406


Locations
United States, Maryland
Parexel Early Phase Unit
Baltimore, Maryland, United States, 21225
Sponsors and Collaborators
Nivalis Therapeutics, Inc.
Investigators
Principal Investigator: Ronald Goldwater, MDCM, MSc(A) Parexel
More Information
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Responsible Party: Nivalis Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01147406     History of Changes
Other Study ID Numbers: N6022-1H1-01
First Posted: June 22, 2010    Key Record Dates
Results First Posted: March 7, 2014
Last Update Posted: March 7, 2014
Last Verified: January 2014