Drug Interaction PotentiationPhase 1NCT02500667
A Drug-Drug Interaction Study of N91115 +/- Rifampin in Healthy Adult Subjects
A Phase 1 study testing N91115 and Rifampin in people with Drug Interaction Potentiation, run by Nivalis Therapeutics, Inc. at 1 site in United States.
Trial summary
The present study is designed to assess the effects of Rifampin on the pharmacokinetics of N91115 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Interaction Potentiation
- What is being tested?
- N91115 and Rifampin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Aug 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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; signs an IRB-approved informed consent
- Subject is healthy as determined by 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 or post-menopausal
- Male subject must agree to use a condom with spermicide and refrain from sperm donation from Day -1 until 30 days post last dose or have a vasectomy at least 6 months prior to screening
- Subject is a non-smoker
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- Subject has a body weight > 45 kg and BMI between 18 and 32 kg/m2
- Subject has no clinically significant vital signs finding at screening or Day -1, per the investigator's judgment
- 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)
- Subject has abnormal 12-lead ECG at screening per protocol
- 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 a current alcohol abuser and/or has a history of illicit drug abuse within 1 year prior to dosing
- Subject has a positive screening test for Hepatitis B surface antigen, Hepatitis C antibody, or human immunodeficiency virus (HIV) antibody
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- Subject is unwilling to refrain from consumption of coffee and caffeine-containing foods and beverages from Day -1 until discharge on Day 14
- Subject is unwilling to abstain from using alcohol beverages from Day -1 until discharge on Day 14
- Subject has donated blood (> 500 mL) or blood products within 56 days prior to Day -1
- Subject has used over-the-counter (OTC) medications (including vitamins) from Day -7, or prescription medications, or herbal remedies from Day -14 until end-of-study follow-up call. By exception, acetaminophen ≤ 1000 mg/day is permitted except within 48 hours prior to Day -1 and hormone replacement therapy (HRT) is allowed throughout the study
- Subject has used an investigational drug within 30 days prior to Day 1 dosing
- Subject has a history of bleeding disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Anthony's Medical Plaza 1
Lakewood, Colorado, 80228
About this study
Official title: A Phase 1, Open-label, Drug-Drug Interaction Study to Assess the Steady State Pharmacokinetics of N91115 Alone and in the Presence of Multiple Dose Administration of Rifampin in Healthy Adult Subjects (SNO-5)
The present study is designed to assess the effects of Rifampin on the pharmacokinetics of N91115 in healthy subjects.
Read the detailed description
This study will assess the effects of multiple oral dose administration of rifampin on the steady state plasma pharmacokinetics (PK) of N91115 in healthy subjects.
Eligible subjects (n=15) will receive oral doses of N91115 twice daily (approximately every 12 hours) on Study Days 1 through the morning of Day 13. On Study Days 8 through 12, rifampin administered 600 mg once daily will be added to the N91115 regimen. Study subjects will be monitored for safety while housed in the clinical research unit (CRU) until discharge on Day 14. Pharmacokinetics will be followed from Study Day 1 through Study Day 14. A follow-up phone call will be made on Day 20 (1 day). Participation of an individual subject may last up to approximately 48 days from the time of screening until the end-of-study follow-up call.
- Conditions
- Drug Interaction Potentiation
- Being tested
- N91115, Rifampin
- Keywords
- N91115, Rifampin, drug interaction, Cavosonstat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N91115Drug
Also called Cavosonstat
200 mg BID
RifampinDrug
Also called Rifadin
600 mg QD
| Study group | Role | What they receive |
|---|---|---|
| N91115 + Rifampin | Experimental | N91115 200 mg twice daily (BID) from Study Day 1- 13, Rifampin 600 mg once daily (QD) from Study Day 8 - 12 Receives: Drug: N91115; Drug: Rifampin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the Potential Effects of Rifampin on N91115 Steady State Area Under the Curve (AUC) Values
To assess the effects of multiple oral dose administration of rifampin on the steady state AUC on Day 14 of N91115 in healthy subjects.
Measured: On Study Day 14
Secondary outcomes (3)
Effects of Rifampin on the AUC vs time of Metabolites of N91115
make a preliminary non statistical assessment on the effects of multiple oral dose administration of rifampin on steady state plasma PK of N91288 and metabolites, in healthy subjects
Measured: On Study Day 14
The number of participants with adverse events
To evaluate the safety and tolerability of multiple oral doses of N91115 in the presence and absence of multiple oral doses of rifampin
Measured: Over the 21 days of the study
Effects of Rifampin on N91115 and its Metabolites on Urine 12 Hour drug concentrations
To make a preliminary non statistical assessment on the effects of multiple oral dose administration of rifampin on the 12 hour steady state urine PK of N91115 and its primary metabolites in healthy subjects
Measured: Day 14 assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drug Interaction PotentiationStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nivalis Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Davita Clinical Research
- Responsible party
- Sponsor
- Investigators
- Christopher Galloway, MD, Principal investigator, Davita Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02500667
- Sponsor's protocol ID
- N91115-1H-04 (SNO-5)
- Status last verified
- Nov 2016
- First submitted
- 10 Jul 2015
- Last updated
- 7 Nov 2016
- Results posted
- No
- 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 7 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Drug-Drug Interaction Study to Assess the Steady State Pharmacokinetics of N91115 Alone and in the Presence of Multiple Dose Administration of Rifampin in Healthy Adult Subjects (SNO-5)
- ClinicalTrials.gov ID
- NCT02500667
- Acronym / sponsor ID
- N91115-1H-04 (SNO-5)
- Conditions
- Drug Interaction Potentiation
- Keywords
- N91115, Rifampin, drug interaction, Cavosonstat
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Nivalis Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Davita Clinical Research
- Study start
- Jun 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 16 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study is designed to assess the effects of Rifampin on the pharmacokinetics of N91115 in healthy subjects.
Detailed description
This study will assess the effects of multiple oral dose administration of rifampin on the steady state plasma pharmacokinetics (PK) of N91115 in healthy subjects.
Eligible subjects (n=15) will receive oral doses of N91115 twice daily (approximately every 12 hours) on Study Days 1 through the morning of Day 13. On Study Days 8 through 12, rifampin administered 600 mg once daily will be added to the N91115 regimen. Study subjects will be monitored for safety while housed in the clinical research unit (CRU) until discharge on Day 14. Pharmacokinetics will be followed from Study Day 1 through Study Day 14. A follow-up phone call will be made on Day 20 (1 day). Participation of an individual subject may last up to approximately 48 days from the time of screening until the end-of-study follow-up call.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| N91115 + Rifampin | Experimental | Drug: N91115, Drug: RifampinN91115 200 mg twice daily (BID) from Study Day 1- 13, Rifampin 600 mg once daily (QD) from Study Day 8 - 12 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Subject voluntarily agrees to participate in this study; signs an IRB-approved informed consent
- Subject is healthy as determined by 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 or post-menopausal
- Male subject must agree to use a condom with spermicide and refrain from sperm donation from Day -1 until 30 days post last dose or have a vasectomy at least 6 months prior to screening
Key exclusion criteria (12 listed)
- Subject has clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s)
- Subject has abnormal 12-lead ECG at screening per protocol
- 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 a current alcohol abuser and/or has a history of illicit drug abuse within 1 year prior to dosing
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: Cavosonstat200 mg BID | Drug | N91115 + Rifampin |
| RifampinAlso: Rifadin600 mg QD | Drug | N91115 + Rifampin |
Primary outcome
Assess the Potential Effects of Rifampin on N91115 Steady State Area Under the Curve (AUC) Values
Time frame: On Study Day 14
To assess the effects of multiple oral dose administration of rifampin on the steady state AUC on Day 14 of N91115 in healthy subjects.
3 secondary outcomes
Effects of Rifampin on the AUC vs time of Metabolites of N91115
Time frame: On Study Day 14
The number of participants with adverse events
Time frame: Over the 21 days of the study
Effects of Rifampin on N91115 and its Metabolites on Urine 12 Hour drug concentrations
Time frame: Day 14 assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2016.
- 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.
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
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 and Rifampin in people with Drug Interaction Potentiation, 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 9 inclusion and 12 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 7 Nov 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assess the Potential Effects of Rifampin on N91115 Steady State Area Under the Curve (AUC) Values (time frame: On Study Day 14). 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 NCT02500667, 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 7 Nov 2016.