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MAD Study Evaluating the Safety, Tolerability, and Pharmacokinetic Effects of N91115 in Healthy Subjects (SNO2)

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ClinicalTrials.gov Identifier: NCT02013388
Recruitment Status : Completed
First Posted : December 17, 2013
Results First Posted : March 18, 2015
Last Update Posted : December 21, 2016
Sponsor:
Information provided by (Responsible Party):
Nivalis Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE December 9, 2013
First Posted Date  ICMJE December 17, 2013
Results First Submitted Date  ICMJE March 5, 2015
Results First Posted Date  ICMJE March 18, 2015
Last Update Posted Date December 21, 2016
Study Start Date  ICMJE February 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2015)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: December 16, 2013)
Safety and Tolerability [ Time Frame: 21 Days ]
Number of subjects with adverse events as measured by, but not limited to, ambulatory ECG monitoring, telemetry, 12-Lead ECGs, abnormal clinical labs, pulse oximetry and vital signs.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2013)
PK [ Time Frame: 14 Days ]
To assess the pharmacokinetics of N91115 after multiple doses over 14 days by measuring plasma concentrations of N91115 and its primary metabolite, N91288.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MAD Study Evaluating the Safety, Tolerability, and Pharmacokinetic Effects of N91115 in Healthy Subjects
Official Title  ICMJE A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study Evaluating the Safety, Tolerability, and Pharmacokinetic Effects of N91115 in Healthy Subjects
Brief Summary 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: N91115
    Given PO daily for 14 days
    Other Name: Cavosonstat
  • Drug: Placebo
    Given PO daily for 14 days
  • Drug: N91115
    Given PO only on Day 1
    Other Name: Cavosonstat
  • Drug: Placebo-Day 1 only
    Given PO- only on Day 1 (single dosed to match single dose treatments)
    Other Name: Placebo
Study Arms  ICMJE
  • Experimental: 10 mg
    single oral daily dose of 10 mg N91115 for 14 days
    Intervention: Drug: N91115
  • Placebo Comparator: Placebo
    single oral daily dose of placebo for 14 days
    Intervention: Drug: Placebo
  • Experimental: 50 mg
    single oral daily dose of 50 mg N91115 for 14 days
    Intervention: Drug: N91115
  • Experimental: 50 mg (single dose)
    single oral dose of 50 mg N91115
    Intervention: Drug: N91115
  • Experimental: 250 mg
    single oral daily dose of 250 mg N91115 for 14 days (fasted)
    Intervention: Drug: N91115
  • Experimental: 250 mg (Fed)
    single oral daily dose of 250 mg N91115 for 1 day (fed fat meal)
    Intervention: Drug: N91115
  • Experimental: 500 mg
    single oral daily dose of 500 mg N91115 for 14 days
    Intervention: Drug: N91115
  • Placebo Comparator: Placebo-Day 1 only
    Single oral dose of placebo (Day 1 only)
    Intervention: Drug: Placebo-Day 1 only
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 9, 2015)
49
Original Estimated Enrollment  ICMJE
 (submitted: December 16, 2013)
24
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02013388
Other Study ID Numbers  ICMJE N91115-1H-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nivalis Therapeutics, Inc.
Study Sponsor  ICMJE Nivalis Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christopher Galloway, MD Davita Clinical Research
Study Director: Steven A Shoemaker, MD Nivalis Therapeutics, Inc.
PRS Account Nivalis Therapeutics, Inc.
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP