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

NCT02013388 | Completed Phase 1 Results DMC

• 1 other identifier: N91115-1H-01
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

N91115; GSNORi; SNO; Cavosonstat

Outcome Measures

Primary Outcomes (5)

• Safety and Tolerability of N91115

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

  21 Days

• Pharmacokinetics: Day 1 AUClast

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

  Day 1

• Pharmacokinetics: AUCtau Day 14

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

  Day 14

• Pharmacokinetics: Day 1 Plasma Cmax Values

  All subjects who completed sample collections for Day 1 plasma N91115

  Day 1

• Pharmacokinetics: Plasma Cmax Values on Day 14

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

  Day 14

Study Arms (8)

10 mg

EXPERIMENTAL

single oral daily dose of 10 mg N91115 for 14 days

Drug: N91115

Placebo

PLACEBO COMPARATOR

single oral daily dose of placebo for 14 days

Drug: Placebo

50 mg

EXPERIMENTAL

single oral daily dose of 50 mg N91115 for 14 days

Drug: N91115

50 mg (single dose)

EXPERIMENTAL

single oral dose of 50 mg N91115

Drug: N91115

250 mg

EXPERIMENTAL

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

Drug: N91115

250 mg (Fed)

EXPERIMENTAL

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

Drug: N91115

500 mg

EXPERIMENTAL

single oral daily dose of 500 mg N91115 for 14 days

Drug: N91115

Placebo-Day 1 only

PLACEBO COMPARATOR

Single oral dose of placebo (Day 1 only)

Drug: Placebo-Day 1 only

Interventions

N91115 DRUG

Given PO daily for 14 days

Also known as: Cavosonstat

10 mg; 250 mg; 50 mg; 500 mg

Placebo DRUG

Given PO daily for 14 days

Placebo

Placebo-Day 1 only DRUG

Given PO- only on Day 1 (single dosed to match single dose treatments)

Also known as: Placebo

Placebo-Day 1 only

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nivalis Therapeutics, Inc.: lead

Study Sites (1)

DaVita Clinical Research

Lakewood, Colorado, 80228, United States

Location

Related Publications (1)

• 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.

  PMID: 28209466 DERIVED

Related Links

• Home Page
• Phase 1 Unit

MeSH Terms

Interventions

cavosonstat

Results Point of Contact

• Title: Nivalis Therapeutics, Inc. (Formerly N30 Pharma)
• Organization: Nivalis Therapeutics, Inc.

steven.shoemaker@nivalis.com

720-945-7700

Study Officials

• Christopher Galloway, MD

  Davita Clinical Research

  PRINCIPAL INVESTIGATOR

• Steven A Shoemaker, MD

  Nivalis Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: December 17, 2013
• Study Start: February 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: February 1, 2015
• Last Updated: December 21, 2016
• Results First Posted: March 18, 2015

Record last verified: 2016-11

Locations

US (1)