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Completed

NCT Number: NCT01147406

Safety and Tolerability Study of N6022 in Healthy Subjects

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

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Parexel Early Phase Unit

Baltimore, Maryland, 21225, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

N6022

Drug

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

Drug

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

Other names: N6022

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Nivalis Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 22, 2010
Registry last updated
Mar 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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