NCT02013388

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

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study Evaluating the Safety, Tolerability, and Pharmacokinetic Effects of N91115 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Nivalis Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Healthy

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-12-01
• Completion: 2015-02-01
• First posted: 2013-12-17
• Last updated: 2016-12-21
• Results posted: 2015-03-18

Locations

1 site across 1 country: United States