HealthyPhase 1SNO2NCT02013388
MAD Study Evaluating the Safety, Tolerability, and Pharmacokinetic Effects of N91115 in Healthy Subjects
A Phase 1 study testing N91115 in people with Healthy, run by Nivalis Therapeutics, Inc. at 1 site in United States.
Trial summary
A study in healthy subjects to assess the safety, tolerability, and pharmacokinetics of N91115. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- N91115
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Feb 2015
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB)-approved informed consent prior to performing any of the screening procedures and in the opinion of the PI complies with all the requirements of the study.
- Subject is healthy, determined at the screening medical evaluation (including but not limited to medical history, physical examination and clinical laboratory evaluations).
- Subject is Caucasian.
- Female subject must be of non-childbearing potential (surgically sterile [hysterectomy or bilateral tubal ligation] or post-menopausal ≥ 1 year with follicle stimulating hormone [FSH] > 40 U/L). Women receiving hormone replacement therapy (HRT) are eligible to enroll.
- Male subject must agree to use condoms and refrain from sperm donation from Day 1 until 30 days post last dose or have documentation of vasectomy.
- Subject has a body weight > 50 kg and body mass index (BMI) between 19.5 and 32 kg/m2, inclusive, at screening.
- Subject has no clinically significant abnormal findings related to their systolic or diastolic blood pressure (BP), per the investigator's judgment, at screening or Day 1.
- Subject has no clinically significant abnormal findings in 12 lead ECG, per the investigator's judgment, at screening.
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 has clinically significant abnormalities on a 12 lead ECG done at screening
- Subject has clinically significant abnormalities on a 48-hour ambulatory ECG done at screening
- Subject has any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs.
- Subject has any concurrent disease or condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the clinical study.
- Subject is unlikely to comply with the protocol requirements, instructions, and study related restrictions; e.g., uncooperative attitude, unavailable for follow-up call, and/or improbability of completing the clinical study.
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, and Pharmacokinetic Effects of N91115 in Healthy Subjects
A study in healthy subjects to assess the safety, tolerability, and pharmacokinetics of N91115.
Read the detailed description
This Phase 1 study in healthy subjects is being conducted to assess the safety, tolerability, and pharmacokinetics of N91115. Also, a comparison of the fasted versus fed with a high fat meal were compared for PK.
- Conditions
- Healthy
- Being tested
- N91115, Placebo, Placebo-Day 1 only
- Keywords
- N91115, GSNORi, SNO, Cavosonstat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N91115Drug
Also called Cavosonstat
Given PO daily for 14 days
PlaceboDrug
Given PO daily for 14 days
N91115Drug
Also called Cavosonstat
Given PO only on Day 1
Placebo-Day 1 onlyDrug
Also called Placebo
Given PO- only on Day 1 (single dosed to match single dose treatments)
| Study group | Role | What they receive |
|---|---|---|
| 10 mg | Experimental | single oral daily dose of 10 mg N91115 for 14 days Receives: Drug: N91115 |
| Placebo | Placebo comparator | single oral daily dose of placebo for 14 days Receives: Drug: Placebo |
| 50 mg | Experimental | single oral daily dose of 50 mg N91115 for 14 days Receives: Drug: N91115 |
| 50 mg (single dose) | Experimental | single oral dose of 50 mg N91115 Receives: Drug: N91115 |
| 250 mg | Experimental | single oral daily dose of 250 mg N91115 for 14 days (fasted) Receives: Drug: N91115 |
| 250 mg (Fed) | Experimental | single oral daily dose of 250 mg N91115 for 1 day (fed fat meal) Receives: Drug: N91115 |
| 500 mg | Experimental | single oral daily dose of 500 mg N91115 for 14 days Receives: Drug: N91115 |
| Placebo-Day 1 only | Placebo comparator | Single oral dose of placebo (Day 1 only) Receives: Drug: Placebo-Day 1 only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of N91115
Assessments are based on numbers of subjects with abnormal clinical evaluations, abnormal laboratory assessments, and adverse events.
Measured: 21 Days
Pharmacokinetics: Day 1 AUClast
Day 1 AUClast plasma values from treatment groups completing 14 days of N91115 administration
Measured: Day 1
Pharmacokinetics: AUCtau Day 14
Plasma analysis of AUCtau values from the end of the dosing period (Day 14) with N91115
Measured: Day 14
Pharmacokinetics: Day 1 Plasma Cmax Values
All subjects who completed sample collections for Day 1 plasma N91115
Measured: Day 1
Pharmacokinetics: Plasma Cmax Values on Day 14
Plasma Cmax values from Day 14 subjects with repeat administration of N91115
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2013 (estimated)
- Study startFeb 2014
- Primary completionDec 2014
- Study completionFeb 2015
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nivalis Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Galloway, MD, Principal investigator, Davita Clinical ResearchSteven A Shoemaker, MD, Study director, Nivalis Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02013388
- Sponsor's protocol ID
- N91115-1H-01
- Acronym
- SNO2
- Status last verified
- Nov 2016
- First submitted
- 9 Dec 2013
- Last updated
- 21 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Donaldson SH, Solomon GM, Zeitlin PL, Flume PA, Casey A, McCoy K, Zemanick ET, Mandagere A, Troha JM, Shoemaker SA, Chmiel JF, Taylor-Cousar JL. Pharmacokinetics and safety of cavosonstat (N91115) in healthy and cystic fibrosis adults homozygous for F508DEL-CFTR. J Cyst Fibros. 2017 May;16(3):371-379. doi: 10.1016/j.jcf.2017.01.009. Epub 2017 Feb 13.
PubMed 28209466
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2016. 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, and Pharmacokinetic Effects of N91115 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02013388
- Acronym / sponsor ID
- SNO2 / N91115-1H-01
- Conditions
- Healthy
- Keywords
- N91115, GSNORi, SNO, Cavosonstat
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Nivalis Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 17 Dec 2013 (estimated)
- Results
- Posted 18 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study in healthy subjects to assess the safety, tolerability, and pharmacokinetics of N91115.
Detailed description
This Phase 1 study in healthy subjects is being conducted to assess the safety, tolerability, and pharmacokinetics of N91115. Also, a comparison of the fasted versus fed with a high fat meal were compared for PK.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 10 mg | Experimental | Drug: N91115single oral daily dose of 10 mg N91115 for 14 days |
| Placebo | Placebo comparator | Drug: Placebosingle oral daily dose of placebo for 14 days |
| 50 mg | Experimental | Drug: N91115single oral daily dose of 50 mg N91115 for 14 days |
| 50 mg (single dose) | Experimental | Drug: N91115single oral dose of 50 mg N91115 |
| 250 mg | Experimental | Drug: N91115single oral daily dose of 250 mg N91115 for 14 days (fasted) |
| 250 mg (Fed) | Experimental | Drug: N91115single oral daily dose of 250 mg N91115 for 1 day (fed fat meal) |
| 500 mg | Experimental | Drug: N91115single oral daily dose of 500 mg N91115 for 14 days |
| Placebo-Day 1 only | Placebo comparator | Drug: Placebo-Day 1 onlySingle oral dose of placebo (Day 1 only) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subject voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB)-approved informed consent prior to performing any of the screening procedures and in the opinion of the PI complies with all the requirements of the study.
- Subject is healthy, determined at the screening medical evaluation (including but not limited to medical history, physical examination and clinical laboratory evaluations).
- Subject is Caucasian.
- Female subject must be of non-childbearing potential (surgically sterile [hysterectomy or bilateral tubal ligation] or post-menopausal ≥ 1 year with follicle stimulating hormone [FSH] > 40 U/L). Women receiving hormone replacement therapy (HRT) are eligible to enroll.
- Male subject must agree to use condoms and refrain from sperm donation from Day 1 until 30 days post last dose or have documentation of vasectomy.
Key exclusion criteria (6 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 has clinically significant abnormalities on a 12 lead ECG done at screening
- Subject has clinically significant abnormalities on a 48-hour ambulatory ECG done at screening
- Subject has any disorder that would interfere with the absorption, distribution, metabolism, or excretion of drugs.
- Subject has any concurrent disease or condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the clinical study.
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 |
|---|---|---|
| N91115Also: CavosonstatGiven PO daily for 14 days | Drug | 10 mg, 250 mg, 50 mg, 500 mg |
| PlaceboGiven PO daily for 14 days | Drug | Placebo |
| N91115Also: CavosonstatGiven PO only on Day 1 | Drug | 250 mg (Fed), 50 mg (single dose) |
| Placebo-Day 1 onlyAlso: PlaceboGiven PO- only on Day 1 (single dosed to match single dose treatments) | Drug | Placebo-Day 1 only |
Primary outcome
Safety and Tolerability of N91115
Time frame: 21 Days
Assessments are based on numbers of subjects with abnormal clinical evaluations, abnormal laboratory assessments, and adverse events.
Pharmacokinetics: Day 1 AUClast
Time frame: Day 1
Day 1 AUClast plasma values from treatment groups completing 14 days of N91115 administration
Pharmacokinetics: AUCtau Day 14
Time frame: Day 14
Plasma analysis of AUCtau values from the end of the dosing period (Day 14) with N91115
Pharmacokinetics: Day 1 Plasma Cmax Values
Time frame: Day 1
All subjects who completed sample collections for Day 1 plasma N91115
Pharmacokinetics: Plasma Cmax Values on Day 14
Time frame: Day 14
Plasma Cmax values from Day 14 subjects with repeat administration of N91115
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28209466Donaldson SH, Solomon GM, Zeitlin PL, Flume PA, Casey A, McCoy K, Zemanick ET, Mandagere A, Troha JM, Shoemaker SA, Chmiel JF, Taylor-Cousar JL. Pharmacokinetics and safety of cavosonstat (N91115) in healthy and cystic fibrosis adults homozygous for F508DEL-CFTR. J Cyst Fibros. 2017 May;16(3):371-379. doi: 10.1016/j.jcf.2017.01.009. Epub 2017 Feb 13.
- Phase 1 UnitLink provided by the sponsor.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Christopher Galloway, MD principal investigator
Davita Clinical Research
Steven A Shoemaker, MD study director
Nivalis Therapeutics, Inc.
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 N91115 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 8 inclusion and 6 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 21 Dec 2016. 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 18 Mar 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 and Tolerability of N91115 (time frame: 21 Days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02013388, which also lists 1 linked publication.
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 21 Dec 2016.