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

Nivalis Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: N91115; Drug: Placebo-Day 1 only

Study type: Interventional

Funder types: Industry

Identifiers

NCT02013388

N91115-1H-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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49 participants in 8 patient groups, including a placebo group

10 mg

Experimental group

Description:

single oral daily dose of 10 mg N91115 for 14 days

Treatment:

Drug: N91115

Drug: N91115

Placebo

Placebo Comparator group

Description:

single oral daily dose of placebo for 14 days

Treatment:

Drug: Placebo

50 mg

Experimental group

Description:

single oral daily dose of 50 mg N91115 for 14 days

Treatment:

Drug: N91115

Drug: N91115

50 mg (single dose)

Experimental group

Description:

single oral dose of 50 mg N91115

Treatment:

Drug: N91115

Drug: N91115

250 mg

Experimental group

Description:

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

Treatment:

Drug: N91115

Drug: N91115

250 mg (Fed)

Experimental group

Description:

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

Treatment:

Drug: N91115

Drug: N91115

500 mg

Experimental group

Description:

single oral daily dose of 500 mg N91115 for 14 days

Treatment:

Drug: N91115

Drug: N91115

Placebo-Day 1 only

Placebo Comparator group

Description:

Single oral dose of placebo (Day 1 only)

Treatment:

Drug: Placebo-Day 1 only