CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 49 enrolled
Drug / intervention
N91115 +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02013388
NCT02013388Phase 1Completed

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

Nivalis Therapeutics, Inc.·interventional·Posted Dec 17, 2013·Updated Dec 21, 2016

In Brief

A Phase 1 clinical trial evaluating N91115, Placebo, and 1 other intervention for Healthy. Completed, enrolled 49 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 17, 2013
Enrollment StartFeb 1, 2014
Primary CompletionDec 1, 2014
Study CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 12.5 years ago

Interventions

N91115drug

Given PO daily for 14 days

Placebodrug

Given PO daily for 14 days

N91115drug

Given PO only on Day 1

Placebo-Day 1 onlydrug

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