ClinicalTrials.gg
Sign In
CompletedNCT01339897Updated Jan 19, 2015Results posted

A Safety Study Evaluating N6022 in Multiple-Ascending Doses in Healthy Subjects

A Phase 1 interventional study of 5 mg/N6022 and Placebo in Healthy, sponsored by Nivalis Therapeutics, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-01-19.

Sponsored by Nivalis Therapeutics, Inc. (part of Vertex Pharmaceuticals Incorporated) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

Read the detailed description

This is a double-blind, randomized, placebo-controlled, multiple ascending dose study, in at least three ascending cohorts. Twenty-four subjects will be enrolled initially in the first three cohorts, with up to 40 subjects to be enrolled overall if additional cohorts are required to reach the maximum tolerated dose (MTD). The cohorts will be enrolled in two groups of 4 each with approximately 7 days between groups to conduct safety monitoring committee review for approval to proceed to the second group in the cohort. Eight subjects will be enrolled per cohort, randomized 3:1 to N6022: placebo. Each subject will undergo screening (Day -28 to Day -2) and, if eligible, they will be instructed to begin a low-nitrate diet on Day -4. Subjects will return to the clinical site on Day -1, and eligibility will be reconfirmed. Eligible subjects will receive a dose of investigational medicinal product ([IMP], N6022 or placebo) by intravenous (IV) infusion on study Days 1 through 7 and will be followed for safety, PK, and PD until discharge on the morning of Day 8. Subjects will return to the clinic for a follow-up visit on Day 15 (± 1 day) and will be contacted via telephone on Day 28 (± 1 day) for the end-of-study safety follow-up visit. Participation of an individual subject may last approximately 56 days from the time of screening until the end-of-study follow-up visit.

A Safety Monitoring Committee (SMC) will review the safety data in each cohort after the Day 15 Follow-up visit, before proceeding to the next ascending dose cohort, modifying the dose, repeating a dose, or stopping the study according to the stopping rules outlined in the protocol.

02

Conditions studied

  • Healthy

Keywords

  • N6022, GSNORi
03

In context

Lead sponsor

Nivalis Therapeutics, Inc. is the lead sponsor of 11 studies on the registry; none are open to participants now.

First submitted before Nivalis Therapeutics, Inc. became part of Vertex Pharmaceuticals Incorporated.

Browse Nivalis Therapeutics, Inc. studies →All Vertex Pharmaceuticals Incorporated studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Subject is healthy, determined by pre-study medical evaluation (medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations
  2. 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.
  3. Subject has a body weight > 50 kg and BMI between 19.5 and 29.5 kg/m2, inclusive, at screening.
  4. Subject has systolic BP > 90 mmHg and diastolic BP > 50 mmHg at screening or Day-1.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. Subject is a current alcohol abuser and/or has a history of illicit drug abuse within six months of entry.
  3. Subject has donated blood (> 500 mL) or blood products within 56 days prior to Day -1.
  4. Subject has a history of bleeding disorders (i.e., severe hemorrhage, melena, rectal bleeding, nosebleeds, bruising, etc.).
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
25 participants (actual)

Study arms

  • Active comparator
    5 mg/N6022

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

    Drug: 5 mg/N6022

  • Placebo comparator
    Placebo

    Injectable formulation normal saline

    Drug: Placebo

  • Active comparator
    10mg/N6022

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

    Drug: 10mg/N6022

  • Active comparator
    20mg/N6022

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

    Drug: 20mg/N6022

Interventions

  • Drug5 mg/N6022

    Drug page: N6022

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

    Also known as: N6022, GSNOR Inhibitor

  • DrugPlacebo

    Same administration procedures as active

    Also known as: Normal Saline

  • Drug10mg/N6022

    Drug page: N6022

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

    Also known as: N6022, GSNOR Inhibitor

  • Drug20mg/N6022

    Drug page: N6022

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

    Also known as: N6022, GSNOR Inhibitor

06

What researchers measure

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)

    Time frame: Over 7 days

Secondary outcomes

  1. Pharmacokinetics of N6022

    N6022 AUC0-tau measurements from Day 1

    Time frame: Day 1, 24 hours

  2. Pharmacokinetics of N6022 Over 7 Days

    Analysis of N6022 AUC0-tau values from Study Day 7

    Time frame: Day 7, 24 hours

  3. Pharmacokinetics of N6022 on Study Day 1

    Analysis of N6022 Cmax values on Study Day 1

    Time frame: Day 1, 24 hours

  4. Pharmacokinetics of N6022 Cmax Values on Study Day 7

    Pharmacokinetic Analysis of N6022 Cmax values on Study Day 7

    Time frame: Day 7, 24 hours

07

Results

Posted Jan 19, 2015

Participant flow

Recruitment occurred between 06April2011 and 09August2011. This study was done at a single Phase 1 site.

Participant flow — Overall Study
Milestone5 mg/N6022Placebo10 mg/N602220 mg/N6022
Started7666
Completed6665
Not completed1001
Withdrew: Adverse event1001

Outcome measures

PrimarySafety 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)

Time frame:
Over 7 days
Reported as:
Number · participants
Safety of Escalating Multiple Doses of N6022 in Healthy Subjects
participantsCohort 1Cohort 2Cohort 3Placebo
Number of subjects on study7666
Early Termination1010
Treatment related AE0010
SecondaryPharmacokinetics of N6022

N6022 AUC0-tau measurements from Day 1

Time frame:
Day 1, 24 hours
Reported as:
Geometric mean · h*ng/mL
Pharmacokinetics of N6022
h*ng/mLCohort 1Cohort 2Cohort 3Placebo
Pharmacokinetics of N6022138 ± 13.0334 ± 21.1669 ± 16.90 ± 0
SecondaryPharmacokinetics of N6022 Over 7 Days

Analysis of N6022 AUC0-tau values from Study Day 7

Time frame:
Day 7, 24 hours
Reported as:
Geometric mean · h*ng/mL
Pharmacokinetics of N6022 Over 7 Days
h*ng/mLCohort 1Cohort 2Cohort 3Placebo
Pharmacokinetics of N6022 Over 7 Days149 ± 24.6367 ± 14.2811 ± 11.30 ± 0
SecondaryPharmacokinetics of N6022 on Study Day 1

Analysis of N6022 Cmax values on Study Day 1

Time frame:
Day 1, 24 hours
Reported as:
Geometric mean · ng/mL
Pharmacokinetics of N6022 on Study Day 1
ng/mLCohort 1Cohort 2Cohort 3Placebo
Pharmacokinetics of N6022 on Study Day 1465 ± 69.81270 ± 95.61400 ± 86.20 ± 0
SecondaryPharmacokinetics of N6022 Cmax Values on Study Day 7

Pharmacokinetic Analysis of N6022 Cmax values on Study Day 7

Time frame:
Day 7, 24 hours
Reported as:
Geometric mean · ng/mL
Pharmacokinetics of N6022 Cmax Values on Study Day 7
ng/mLCohort 1Cohort 2Cohort 3Placebo
Pharmacokinetics of N6022 Cmax Values on Study Day 7287 ± 89.81110 ± 34.12320 ± 13.50 ± 0

Adverse events

Collected over 7 Days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cohort 1—0/7 (0%)7/7 (100%)
Cohort 2—0/6 (0%)2/6 (33.3%)
Cohort 3—0/6 (0%)4/6 (66.7%)
Placebo—0/6 (0%)5/6 (83.3%)
Most frequent other events
Showing 10 of 26
Most frequent other events
EventCohort 1Cohort 2Cohort 3Placebo
Contact DermatitisSkin and subcutaneous tissue disorders0/70/60/62/6
Ventricular ArrythmiaCardiac disorders1/70/61/60/6
DizzinessNervous system disorders1/70/61/60/6
Vessel Puncture Site HematomaGeneral disorders0/71/60/60/6
Upper Respiratory tract InfectionInfections and infestations0/71/60/60/6
Traumatic HematomaInjury, poisoning and procedural complications0/71/60/60/6
Abdominal DiscomfortGastrointestinal disorders0/70/61/60/6
DiarrheaGastrointestinal disorders0/70/61/60/6
NauseaGastrointestinal disorders0/70/61/60/6
Blood Magnesium AbnormalInvestigations0/70/61/60/6

Baseline characteristics

All randomized subjects who received any amount of IMP

Age, Categorical
Age, Categorical(Participants)Cohort 1Cohort 2Cohort 3PlaceboTotal
<=18 years00000
Between 18 and 65 years766625
>=65 years00000
Age, Continuous
Age, Continuous(years)Cohort 1Cohort 2Cohort 3PlaceboTotal
Median32 (25 to 39)31 (22 to 45)35 (22 to 45)35 (25 to 45)33 (22 to 45)
Sex: Female, Male
Sex: Female, Male(Participants)Cohort 1Cohort 2Cohort 3PlaceboTotal
Female00000
Male766625
Region of Enrollment
Region of Enrollment(participants)Cohort 1Cohort 2Cohort 3PlaceboTotal
United States766625
08

Study locations

1 site
  • Parexel International
    Baltimore, Maryland 21225, United States
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2011, a primary completion of Aug 2011 and a completion of Aug 2011. It does not say whether these dates are actual or estimated.

Results were first posted in Jan 2015, 3 years 5 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 19, 2011
First posted
Apr 21, 2011
Start
Apr 2011
Primary completionActual
Aug 2011
CompletionActual
Aug 2011
Results first posted
Jan 19, 2015
Last update
Jan 19, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 19, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01339897
Lead sponsor
Nivalis Therapeutics, Inc.
Responsible party
Sponsor
First posted
Apr 21, 2011
Start date
Apr 2011
Primary completion
Aug 2011
Completion
Aug 2011
Results posted
Jan 19, 2015
Last update
Jan 19, 2015

Study contacts

Ronald Goldwater, MDCM, MSc(A)
principal investigator · Parexel

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Nivalis Therapeutics, Inc. →

Start the discussion