MAD Study Evaluating the Safety, Tolerability, and Pharmacokinetic Effects of N91115 in Healthy Subjects
NCT ID: NCT02013388
Last Updated: 2016-12-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
49 participants
INTERVENTIONAL
2014-02-28
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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10 mg
single oral daily dose of 10 mg N91115 for 14 days
N91115
Given PO daily for 14 days
Placebo
single oral daily dose of placebo for 14 days
Placebo
Given PO daily for 14 days
50 mg
single oral daily dose of 50 mg N91115 for 14 days
N91115
Given PO daily for 14 days
50 mg (single dose)
single oral dose of 50 mg N91115
N91115
Given PO only on Day 1
250 mg
single oral daily dose of 250 mg N91115 for 14 days (fasted)
N91115
Given PO daily for 14 days
250 mg (Fed)
single oral daily dose of 250 mg N91115 for 1 day (fed fat meal)
N91115
Given PO only on Day 1
500 mg
single oral daily dose of 500 mg N91115 for 14 days
N91115
Given PO daily for 14 days
Placebo-Day 1 only
Single oral dose of placebo (Day 1 only)
Placebo-Day 1 only
Given PO- only on Day 1 (single dosed to match single dose treatments)
Interventions
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N91115
Given PO daily for 14 days
Placebo
Given PO daily for 14 days
N91115
Given PO only on Day 1
Placebo-Day 1 only
Given PO- only on Day 1 (single dosed to match single dose treatments)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
55 Years
ALL
Yes
Sponsors
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Nivalis Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Christopher Galloway, MD
Role: PRINCIPAL_INVESTIGATOR
Davita Clinical Research
Steven A Shoemaker, MD
Role: STUDY_DIRECTOR
Nivalis Therapeutics, Inc.
Locations
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DaVita Clinical Research
Lakewood, Colorado, United States
Countries
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References
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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.
Related Links
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Home Page
Phase 1 Unit
Other Identifiers
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N91115-1H-01
Identifier Type: -
Identifier Source: org_study_id