HealthyPhase 1NCT01339897
A Safety Study Evaluating N6022 in Multiple-Ascending Doses in Healthy Subjects
A Phase 1 study testing 5 mg/N6022, 10mg/N6022 and 20mg/N6022 in people with Healthy, run by Nivalis Therapeutics, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 5 mg/N6022, 10mg/N6022 and 20mg/N6022
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Aug 2011
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study Evaluating the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of N6022 in Healthy Subjects
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.
- Conditions
- Healthy
- Being tested
- 5 mg/N6022, Placebo, 10mg/N6022, 20mg/N6022
- Keywords
- N6022, GSNORi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 mg/N6022Drug
Also called N6022, GSNOR Inhibitor
Intravenous formulation, given at doses of 5 mg once each day over 7 days.
PlaceboDrug
Also called Normal Saline
Same administration procedures as active
10mg/N6022Drug
Also called N6022, GSNOR Inhibitor
Intravenous formulation given at doses of 10 mg once each day over 7 days.
20mg/N6022Drug
Also called N6022, GSNOR Inhibitor
Intravenous formulation given at doses of 20 mg once each day over 7 days.
| Study group | Role | What they receive |
|---|---|---|
| 5 mg/N6022 | Active comparator | Injectable formulation, given at doses per cohort of 5 mg given QD each day over 7 days. Receives: Drug: 5 mg/N6022 |
| Placebo | Placebo comparator | Injectable formulation normal saline Receives: Drug: Placebo |
| 10mg/N6022 | Active comparator | Injectable formulation, given at doses of 10 mg given QD each day over 7 days. Receives: Drug: 10mg/N6022 |
| 20mg/N6022 | Active comparator | Injectable formulation, given at doses per cohort of 20 mg given QD each day over 7 days. Receives: Drug: 20mg/N6022 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Over 7 days
Secondary outcomes (4)
Pharmacokinetics of N6022
N6022 AUC0-tau measurements from Day 1
Measured: Day 1, 24 hours
Pharmacokinetics of N6022 Over 7 Days
Analysis of N6022 AUC0-tau values from Study Day 7
Measured: Day 7, 24 hours
Pharmacokinetics of N6022 on Study Day 1
Analysis of N6022 Cmax values on Study Day 1
Measured: Day 1, 24 hours
Pharmacokinetics of N6022 Cmax Values on Study Day 7
Pharmacokinetic Analysis of N6022 Cmax values on Study Day 7
Measured: Day 7, 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nivalis Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ronald Goldwater, MDCM, MSc(A), Principal investigator, Parexel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01339897
- Sponsor's protocol ID
- N6022-1H1-03
- Status last verified
- Jan 2015
- First submitted
- 19 Apr 2011
- Last updated
- 19 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study Evaluating the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of N6022 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01339897
- Acronym / sponsor ID
- N6022-1H1-03
- Conditions
- Healthy
- Keywords
- N6022, GSNORi
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Nivalis Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 21 Apr 2011 (estimated)
- Results
- Posted 19 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 5 mg/N6022 | Active comparator | Drug: 5 mg/N6022Injectable formulation, given at doses per cohort of 5 mg given QD each day over 7 days. |
| Placebo | Placebo comparator | Drug: PlaceboInjectable formulation normal saline |
| 10mg/N6022 | Active comparator | Drug: 10mg/N6022Injectable formulation, given at doses of 10 mg given QD each day over 7 days. |
| 20mg/N6022 | Active comparator | Drug: 20mg/N6022Injectable formulation, given at doses per cohort of 20 mg given QD each day over 7 days. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5 mg/N6022Also: N6022, GSNOR InhibitorIntravenous formulation, given at doses of 5 mg once each day over 7 days. | Drug | 5 mg/N6022 |
| PlaceboAlso: Normal SalineSame administration procedures as active | Drug | Placebo |
| 10mg/N6022Also: N6022, GSNOR InhibitorIntravenous formulation given at doses of 10 mg once each day over 7 days. | Drug | 10mg/N6022 |
| 20mg/N6022Also: N6022, GSNOR InhibitorIntravenous formulation given at doses of 20 mg once each day over 7 days. | Drug | 20mg/N6022 |
Primary outcome
Safety of Escalating Multiple Doses of N6022 in Healthy Subjects
Time frame: Over 7 days
Safety variables (adverse events, vital signs, physical examination, telemetry, 12-lead ECG, infusion site reactions, O2 saturation, and clinical laboratory assessments)
4 secondary outcomes
Pharmacokinetics of N6022
Time frame: Day 1, 24 hours
Pharmacokinetics of N6022 Over 7 Days
Time frame: Day 7, 24 hours
Pharmacokinetics of N6022 on Study Day 1
Time frame: Day 1, 24 hours
Pharmacokinetics of N6022 Cmax Values on Study Day 7
Time frame: Day 7, 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Healthy
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
RecruitingObservational study
Collection and Analysis of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers
Healthy Volunteers
RecruitingPhase 1
Bioequivalence Study Between YHP2508A and YHR2601 in Healthy Subjects
Healthy Subjects (HS)
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingObservational study
Relationship Between Great Toe Strength And Symptoms of Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Chemotherapy-induced Peripheral Neuropathy (CIPN), Healthy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald Goldwater, MDCM, MSc(A) principal investigator
Parexel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 5 mg/N6022, 10mg/N6022 and 20mg/N6022 in people with Healthy, run by Nivalis Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Escalating Multiple Doses of N6022 in Healthy Subjects (time frame: Over 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2015.