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

Sponsor
Nivalis Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02013388
Collaborator
(none)
49
Enrollment
1
Location
8
Arms
12
Duration (Months)
4.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A study in healthy subjects to assess the safety, tolerability, and pharmacokinetics of N91115.

Condition or Disease Intervention/Treatment Phase
Phase 1

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

Study Type:
Interventional
Actual Enrollment :
49 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Study Start Date :
Feb 1, 2014
Actual Primary Completion Date :
Dec 1, 2014
Actual Study Completion Date :
Feb 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: 10 mg

single oral daily dose of 10 mg N91115 for 14 days

Drug: N91115
Given PO daily for 14 days
Other Names:
  • Cavosonstat

    		•
    Placebo Comparator: Placebo

    single oral daily dose of placebo for 14 days

    Drug: Placebo
    Given PO daily for 14 days
    Experimental: 50 mg

    single oral daily dose of 50 mg N91115 for 14 days

    Drug: N91115
    Given PO daily for 14 days
    Other Names:
  • Cavosonstat

    		•
    Experimental: 50 mg (single dose)

    single oral dose of 50 mg N91115

    Drug: N91115
    Given PO only on Day 1
    Other Names:
  • Cavosonstat

    		•
    Experimental: 250 mg

    single oral daily dose of 250 mg N91115 for 14 days (fasted)

    Drug: N91115
    Given PO daily for 14 days
    Other Names:
  • Cavosonstat

    		•
    Experimental: 250 mg (Fed)

    single oral daily dose of 250 mg N91115 for 1 day (fed fat meal)

    Drug: N91115
    Given PO only on Day 1
    Other Names:
  • Cavosonstat

    		•
    Experimental: 500 mg

    single oral daily dose of 500 mg N91115 for 14 days

    Drug: N91115
    Given PO daily for 14 days
    Other Names:
  • Cavosonstat

    		•
    Placebo Comparator: Placebo-Day 1 only

    Single oral dose of placebo (Day 1 only)

    Drug: Placebo-Day 1 only
    Given PO- only on Day 1 (single dosed to match single dose treatments)
    Other Names:
  • Placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety and Tolerability of N91115 [21 Days]

      Assessments are based on numbers of subjects with abnormal clinical evaluations, abnormal laboratory assessments, and adverse events.

    2. Pharmacokinetics: Day 1 AUClast [Day 1]

      Day 1 AUClast plasma values from treatment groups completing 14 days of N91115 administration

    3. Pharmacokinetics: AUCtau Day 14 [Day 14]

      Plasma analysis of AUCtau values from the end of the dosing period (Day 14) with N91115

    4. Pharmacokinetics: Day 1 Plasma Cmax Values [Day 1]

      All subjects who completed sample collections for Day 1 plasma N91115

    5. Pharmacokinetics: Plasma Cmax Values on Day 14 [Day 14]

      Plasma Cmax values from Day 14 subjects with repeat administration of N91115

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 DaVita Clinical Research Lakewood Colorado United States 80228

    Sponsors and Collaborators

    • Nivalis Therapeutics, Inc.

    Investigators

    • Principal Investigator: Christopher Galloway, MD, Davita Clinical Research
    • Study Director: Steven A Shoemaker, MD, Nivalis Therapeutics, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Nivalis Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT02013388
    Other Study ID Numbers:
    • N91115-1H-01
    First Posted:
    Dec 17, 2013
    Last Update Posted:
    Dec 21, 2016
    Last Verified:
    Nov 1, 2016
    Keywords provided by Nivalis Therapeutics, Inc.
    N91115
    GSNORi
    SNO
    Cavosonstat

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Placebo 10 mg 50 mg 250 mg 500 mg 50 mg (Single Dose) 250 mg (Fed) Placebo-single Dose
    Arm/Group Description single oral daily dose of placebo for 14 days Placebo: Given PO daily for 14 days single oral daily dose of 10 mg N91115 for 14 days N91115: Given PO daily for 14 days single oral daily dose of 50 mg N91115 for 14 days N91115: Given PO daily for 14 days single oral daily dose of 250 mg N91115 for 14 days (fasted) N91115: Given PO daily for 14 days single oral daily dose of 500 mg N91115 for 14 days N91115: Given PO daily for 14 days single oral dose of 50 mg N91115 N91115: Given PO only on Day 1 single oral daily dose of 250 mg N91115 for 1 day (fed fat meal) N91115: Given PO only on Day 1 Placebo: Given PO daily for 1 day
    Period Title: Overall Study
    STARTED 9 6 6 6 6 6 6 4
    COMPLETED 8 6 6 6 5 6 6 4
    NOT COMPLETED 1 0 0 0 1 0 0 0

    Baseline Characteristics

    Arm/Group Title Placebo 10 mg 50 mg 250 mg 500 mg 50 mg (Single Dose) 250 mg (Fed) Placebo- Single Dose Total
    Arm/Group Description single oral daily dose of placebo for 14 days Placebo: Given PO daily for 14 days single oral daily dose of 10 mg N91115 for 14 days N91115: Given PO daily for 14 days single oral daily dose of 50 mg N91115 for 14 days N91115: Given PO daily for 14 days single oral daily dose of 250 mg N91115 for 14 days (fasted) N91115: Given PO daily for 14 days single oral daily dose of 500 mg N91115 for 14 days N91115: Given PO daily for 14 days single oral dose of 50 mg N91115 N91115: Given PO only on Day 1 single oral daily dose of 250 mg N91115 for 1 day (fed fat meal) N91115: Given PO only on Day 1 single oral dose Placebo: Given PO daily for 1day Total of all reporting groups
    Overall Participants 9 6 6 6 6 6 6 4 49
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    35.6
    (12.32)
    41.3
    (14.90)
    40.2
    (14.25)
    39.7
    (10.03)
    37.3
    (10.91)
    42.3
    (9.40)
    37.8
    (11.84)
    41.3
    (11.59)
    39.1
    (11.40)
    Gender (Count of Participants)
    Female
    1
    11.1%
    2
    33.3%
    2
    33.3%
    2
    33.3%
    5
    83.3%
    0
    0%
    2
    33.3%
    2
    50%
    16
    32.7%
    Male
    8
    88.9%
    4
    66.7%
    4
    66.7%
    4
    66.7%
    1
    16.7%
    6
    100%
    4
    66.7%
    2
    50%
    33
    67.3%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    1
    11.1%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    2%
    Not Hispanic or Latino
    8
    88.9%
    6
    100%
    6
    100%
    6
    100%
    6
    100%
    6
    100%
    6
    100%
    4
    100%
    48
    98%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    White
    8
    88.9%
    6
    100%
    6
    100%
    6
    100%
    6
    100%
    6
    100%
    6
    100%
    4
    100%
    48
    98%
    More than one race
    1
    11.1%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    2%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%

    Outcome Measures

    1. Primary Outcome
    Title Safety and Tolerability of N91115
    Description Assessments are based on numbers of subjects with abnormal clinical evaluations, abnormal laboratory assessments, and adverse events.
    Time Frame 21 Days

    Outcome Measure Data

    Analysis Population Description
    All patients enrolled in the study were evaluated for safety endpoints
    Arm/Group Title Placebo 10 mg 50 mg 250 mg 500 mg 50 mg (Single Dose) 250 mg (Fed) Placebo- Single Dose
    Arm/Group Description single oral daily dose of placebo for 14 days Placebo: Given PO daily for 14 days single oral daily dose of 10 mg N91115 for 14 days N91115: Given PO daily for 14 days single oral daily dose of 50 mg N91115 for 14 days N91115: Given PO daily for 14 days single oral daily dose of 250 mg N91115 for 14 days (fasted) N91115: Given PO daily for 14 days single oral daily dose of 500 mg N91115 for 14 days N91115: Given PO daily for 14 days single oral dose of 50 mg N91115 N91115: Given PO only on Day 1 single oral daily dose of 250 mg N91115 for 1 day (fed fat meal) N91115: Given PO only on Day 1 single oral dose Placebo: Given PO daily for 1day
    Measure Participants 9 6 6 6 6 6 6 4
    Subjects with at least one TEAE
    9
    100%
    6
    100%
    6
    100%
    6
    100%
    6
    100%
    1
    16.7%
    4
    66.7%
    2
    50%
    Subjects with at least one study treatment TEAE
    5
    55.6%
    4
    66.7%
    4
    66.7%
    2
    33.3%
    2
    33.3%
    1
    16.7%
    0
    0%
    1
    25%
    2. Primary Outcome
    Title Pharmacokinetics: Day 1 AUClast
    Description Day 1 AUClast plasma values from treatment groups completing 14 days of N91115 administration
    Time Frame Day 1

    Outcome Measure Data

    Analysis Population Description
    All patients that had plasma samples collected were included in the analysis
    Arm/Group Title 10 mg 50 mg 250 mg 500 mg
    Arm/Group Description single oral daily dose of 10 mg N91115 for 14 days N91115: Given PO daily for 14 days single oral daily dose of 50 mg N91115 for 14 days N91115: Given PO daily for 14 days single oral daily dose of 250 mg N91115 for 14 days (fasted) N91115: Given PO daily for 14 days single oral daily dose of 500 mg N91115 for 14 days N91115: Given PO daily for 14 days
    Measure Participants 6 6 6 5
    Geometric Mean (Geometric Coefficient of Variation) [h*ng/mL]
    327
    (24.0)
    1530
    (23.5)
    12000
    (20.6)
    32400
    (44.4)
    3. Primary Outcome
    Title Pharmacokinetics: AUCtau Day 14
    Description Plasma analysis of AUCtau values from the end of the dosing period (Day 14) with N91115
    Time Frame Day 14

    Outcome Measure Data

    Analysis Population Description
    All patients that completed the required days of dosing to study end
    Arm/Group Title 10 mg 50 mg 250 mg 500 mg
    Arm/Group Description single oral daily dose of 10 mg N91115 for 14 days N91115: Given PO daily for 14 days single oral daily dose of 50 mg N91115 for 14 days N91115: Given PO daily for 14 days single oral daily dose of 250 mg N91115 for 14 days (fasted) N91115: Given PO daily for 14 days single oral daily dose of 500 mg N91115 for 14 days N91115: Given PO daily for 14 days
    Measure Participants 6 6 6 5
    Geometric Mean (Geometric Coefficient of Variation) [h*ng/mL]
    423
    (17.1)
    2240
    (23.4)
    14500
    (17.9)
    36000
    (41.7)
    4. Primary Outcome
    Title Pharmacokinetics: Day 1 Plasma Cmax Values
    Description All subjects who completed sample collections for Day 1 plasma N91115
    Time Frame Day 1

    Outcome Measure Data

    Analysis Population Description
    All subjects that completed the plasma collection sampling were included in the analysis
    Arm/Group Title 10 mg 50 mg 250 mg 500 mg
    Arm/Group Description single oral daily dose of 10 mg N91115 for 14 days N91115: Given PO daily for 14 days single oral daily dose of 50 mg N91115 for 14 days N91115: Given PO daily for 14 days single oral daily dose of 250 mg N91115 for 14 days (fasted) N91115: Given PO daily for 14 days single oral daily dose of 500 mg N91115 for 14 days N91115: Given PO daily for 14 days
    Measure Participants 6 6 6 5
    Geometric Mean (Geometric Coefficient of Variation) [ng/mL]
    33.0
    (32.2)
    245
    (55.4)
    1810
    (50.2)
    3840
    (39.6)
    5. Primary Outcome
    Title Pharmacokinetics: Plasma Cmax Values on Day 14
    Description Plasma Cmax values from Day 14 subjects with repeat administration of N91115
    Time Frame Day 14

    Outcome Measure Data

    Analysis Population Description
    All subjects completing plasma collection sampling for N91115
    Arm/Group Title 10 mg 50 mg 250 mg 500 mg
    Arm/Group Description single oral daily dose of 10 mg N91115 for 14 days N91115: Given PO daily for 14 days single oral daily dose of 50 mg N91115 for 14 days N91115: Given PO daily for 14 days single oral daily dose of 250 mg N91115 for 14 days (fasted) N91115: Given PO daily for 14 days single oral daily dose of 500 mg N91115 for 14 days N91115: Given PO daily for 14 days
    Measure Participants 6 6 6 5
    Geometric Mean (Geometric Coefficient of Variation) [ng/mL]
    84.3
    (44.4)
    445
    (48.6)
    2410
    (30.3)
    5800
    (67.2)

    Adverse Events

    Time Frame AEs were collected from the time of informed consent for the study duration (up to 14 days) and during a non-dosing period of 7 days afterwards.
    Adverse Event Reporting Description Treatment emergent adverse event (TEAE), defined as AEs that are not present prior to the start of study medication, or present before study medication that worsened after starting study medication. TEAEs may be related to study or a procedure conducted during the study. Subject is counted only once within System organ class and preferred term.
    Arm/Group Title Placebo 10 mg 50 mg 250 mg 500 mg 50 mg (Single Dose) 250 mg (Fed) Placebo- Single Dose
    Arm/Group Description single oral daily dose of placebo for 14 days Placebo: Given PO daily for 14 days single oral daily dose of 10 mg N91115 for 14 days N91115: Given PO daily for 14 days single oral daily dose of 50 mg N91115 for 14 days N91115: Given PO daily for 14 days single oral daily dose of 250 mg N91115 for 14 days (fasted) N91115: Given PO daily for 14 days single oral daily dose of 500 mg N91115 for 14 days N91115: Given PO daily for 14 days single oral dose of 50 mg N91115 N91115: Given PO only on Day 1 single oral daily dose of 250 mg N91115 for 1 day (fed fat meal) N91115: Given PO only on Day 1 single oral dose Placebo: Given PO daily for 1day
    All Cause Mortality
    Placebo 10 mg 50 mg 250 mg 500 mg 50 mg (Single Dose) 250 mg (Fed) Placebo- Single Dose
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Placebo 10 mg 50 mg 250 mg 500 mg 50 mg (Single Dose) 250 mg (Fed) Placebo- Single Dose
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/9 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/6 (0%) 0/4 (0%)
    Other (Not Including Serious) Adverse Events
    Placebo 10 mg 50 mg 250 mg 500 mg 50 mg (Single Dose) 250 mg (Fed) Placebo- Single Dose
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 9/9 (100%) 6/6 (100%) 6/6 (100%) 6/6 (100%) 6/6 (100%) 1/6 (16.7%) 4/6 (66.7%) 2/4 (50%)
    Cardiac disorders
    Palpitation 0/9 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0
    Ventricular Extrasystoles 0/9 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0
    Eye disorders
    Conjunctivitis 0/9 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0
    Eye Pruritus 0/9 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0
    Gastrointestinal disorders
    Aphthous Stomatitis 1/9 (11.1%) 1 2/6 (33.3%) 2 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0
    Constipation 1/9 (11.1%) 1 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0
    Diarrhea 0/9 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0
    Change Of Bowel Habit 0/9 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0
    Dyspepsia 0/9 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/4 (0%) 0
    Nausea 0/9 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0
    Injury, poisoning and procedural complications
    Soft Tissue Injury 0/9 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0
    Musculoskeletal and connective tissue disorders
    Muscle Spasms 1/9 (11.1%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0
    Pain In Extremity 0/9 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0
    Nervous system disorders
    Headache 1/9 (11.1%) 1 3/6 (50%) 3 1/6 (16.7%) 1 0/6 (0%) 0 1/6 (16.7%) 1 1/6 (16.7%) 1 0/6 (0%) 0 1/4 (25%) 1
    Dizziness 2/9 (22.2%) 2 0/6 (0%) 0 2/6 (33.3%) 2 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0
    Renal and urinary disorders
    Urine Odor Abnormal 1/9 (11.1%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Cough 0/9 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 0/4 (0%) 0
    Epistaxis 0/9 (0%) 0 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0
    Skin and subcutaneous tissue disorders
    Dermatitis Contact 9/9 (100%) 9 6/6 (100%) 6 6/6 (100%) 6 6/6 (100%) 6 6/6 (100%) 6 0/6 (0%) 0 4/6 (66.7%) 4 1/4 (25%) 1
    Dermatitis 0/9 (0%) 0 0/6 (0%) 0 0/6 (0%) 0 1/6 (16.7%) 1 1/6 (16.7%) 1 0/6 (0%) 0 0/6 (0%) 0 0/4 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Nivalis Therapeutics, Inc. (Formerly N30 Pharma)
    Organization Nivalis Therapeutics, Inc.
    Phone 720-945-7700
    Email steven.shoemaker@nivalis.com
    Responsible Party:
    Nivalis Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT02013388
    Other Study ID Numbers:
    • N91115-1H-01
    First Posted:
    Dec 17, 2013
    Last Update Posted:
    Dec 21, 2016
    Last Verified:
    Nov 1, 2016