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Trial record 7 of 9 for:    N91115
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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.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Healthy
Interventions Drug: N91115
Drug: Placebo
Drug: Placebo-Day 1 only
Enrollment 49
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo 10 mg 50 mg 250 mg 500 mg 50 mg (Single Dose) 250 mg (Fed) Placebo-single Dose
Hide 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
Reason Not Completed
work emergency             1             0             0             0             1             0             0             0
Arm/Group Title Placebo 10 mg 50 mg 250 mg 500 mg 50 mg (Single Dose) 250 mg (Fed) Placebo- Single Dose Total
Hide 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 Number of Baseline Participants 9 6 6 6 6 6 6 4 49
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 4 participants 49 participants
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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 4 participants 49 participants
Female
1
  11.1%
2
  33.3%
2
  33.3%
2
  33.3%
5
  83.3%
0
   0.0%
2
  33.3%
2
  50.0%
16
  32.7%
Male
8
  88.9%
4
  66.7%
4
  66.7%
4
  66.7%
1
  16.7%
6
 100.0%
4
  66.7%
2
  50.0%
33
  67.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 4 participants 49 participants
Hispanic or Latino
1
  11.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.0%
Not Hispanic or Latino
8
  88.9%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
4
 100.0%
48
  98.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 6 participants 6 participants 6 participants 6 participants 6 participants 6 participants 4 participants 49 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
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%
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%
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%
0
   0.0%
0
   0.0%
0
   0.0%
White
8
  88.9%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
4
 100.0%
48
  98.0%
More than one race
1
  11.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Safety and Tolerability of N91115
Hide Description Assessments are based on numbers of subjects with abnormal clinical evaluations, abnormal laboratory assessments, and adverse events.
Time Frame 21 Days
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 9 6 6 6 6 6 6 4
Measure Type: Number
Unit of Measure: participants
Subjects with at least one TEAE 9 6 6 6 6 1 4 2
Subjects with at least one study treatment TEAE 5 4 4 2 2 1 0 1
2.Primary Outcome
Title Pharmacokinetics: Day 1 AUClast
Hide Description Day 1 AUClast plasma values from treatment groups completing 14 days of N91115 administration
Time Frame Day 1
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 6 6 6 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*ng/mL
327
(24.0%)
1530
(23.5%)
12000
(20.6%)
32400
(44.4%)
3.Primary Outcome
Title Pharmacokinetics: AUCtau Day 14
Hide Description Plasma analysis of AUCtau values from the end of the dosing period (Day 14) with N91115
Time Frame Day 14
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 6 6 6 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: 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
Hide Description All subjects who completed sample collections for Day 1 plasma N91115
Time Frame Day 1
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 6 6 6 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: 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
Hide Description Plasma Cmax values from Day 14 subjects with repeat administration of N91115
Time Frame Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects completing plasma collection sampling for N91115
Arm/Group Title 10 mg 50 mg 250 mg 500 mg
Hide 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
Overall Number of Participants Analyzed 6 6 6 5
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
84.3
(44.4%)
445
(48.6%)
2410
(30.3%)
5800
(67.2%)
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
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Hide 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 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/4 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
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 (100.00%)      6/6 (100.00%)      6/6 (100.00%)      6/6 (100.00%)      6/6 (100.00%)      1/6 (16.67%)      4/6 (66.67%)      2/4 (50.00%)    
Cardiac disorders                 
Palpitation † 1  0/9 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0
Ventricular Extrasystoles † 1  0/9 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0
Eye disorders                 
Conjunctivitis † 1  0/9 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0
Eye Pruritus † 1  0/9 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0
Gastrointestinal disorders                 
Aphthous Stomatitis † 1  1/9 (11.11%)  1 2/6 (33.33%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0
Constipation † 1  1/9 (11.11%)  1 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0
Diarrhea † 1  0/9 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0
Change Of Bowel Habit † 1  0/9 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0
Dyspepsia † 1  0/9 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/4 (0.00%)  0
Nausea † 1  0/9 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0
Injury, poisoning and procedural complications                 
Soft Tissue Injury † 1  0/9 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0
Musculoskeletal and connective tissue disorders                 
Muscle Spasms † 1  1/9 (11.11%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0
Pain In Extremity † 1  0/9 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0
Nervous system disorders                 
Headache † 1  1/9 (11.11%)  1 3/6 (50.00%)  3 1/6 (16.67%)  1 0/6 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0 1/4 (25.00%)  1
Dizziness † 1  2/9 (22.22%)  2 0/6 (0.00%)  0 2/6 (33.33%)  2 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0
Renal and urinary disorders                 
Urine Odor Abnormal † 1  1/9 (11.11%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                 
Cough † 1  0/9 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/4 (0.00%)  0
Epistaxis † 1  0/9 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0
Skin and subcutaneous tissue disorders                 
Dermatitis Contact † 1  9/9 (100.00%)  9 6/6 (100.00%)  6 6/6 (100.00%)  6 6/6 (100.00%)  6 6/6 (100.00%)  6 0/6 (0.00%)  0 4/6 (66.67%)  4 1/4 (25.00%)  1
Dermatitis † 1  0/9 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/4 (0.00%)  0
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA, Version 16.1
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Nivalis Therapeutics, Inc. (Formerly N30 Pharma)
Organization: Nivalis Therapeutics, Inc.
Phone: 720-945-7700
EMail: steven.shoemaker@nivalis.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Nivalis Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02013388    
Other Study ID Numbers: N91115-1H-01
First Submitted: December 9, 2013
First Posted: December 17, 2013
Results First Submitted: March 5, 2015
Results First Posted: March 18, 2015
Last Update Posted: December 21, 2016