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

NCT02013388 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2016-12-21

Study results available
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Summary

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

Conditions

  • Healthy

Interventions

DRUG

N91115

Given PO daily for 14 days

DRUG

Placebo

Given PO daily for 14 days

DRUG

N91115

Given PO only on Day 1

DRUG

Placebo-Day 1 only

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

Sponsors & Collaborators

  • Nivalis Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Christopher Galloway, MD · Davita Clinical Research

  • Steven A Shoemaker, MD · Nivalis Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2014-12-31
Completion
2015-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02013388 on ClinicalTrials.gov