Safety and Pharmacokinetic Study of N6022 in Subjects With Cystic Fibrosis Homozygous for the F508del-CFTR Mutation

PHASE1CompletedINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

February 28, 2014

Primary Completion Date

April 30, 2014

Study Completion Date

May 31, 2014

Conditions
Cystic Fibrosis
Interventions
DRUG

N6022

Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes depending on the dose

DRUG

Normal saline

Intravenous solution of 0.9% (weight/volume) NaCl administered by infusion pump over 1-8 minutes depending on dose of active drug used in same cohort

Trial Locations (17)

15224

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

19104

Children's Hospital of Philadelphia, Philadelphia

21287

Johns Hopkins Hospital, Baltimore

27599

University of North Carolina, Chapel Hill

35294

University of Alabama, Birmingham

43205

Nationwide Children's Hospital, Columbus

44106

Rainbow Babies and Children's Hospital - Case Medical Center, Cleveland

45229

Cincinnati Children's Hospital, Cincinnati

52242

University of Iowa Children's Hospital, Iowa City

55455

University of Minnesota, Minneapolis

60611

Northwestern University, Chicago

63110

Washington University, St Louis

80045

Children's Hospital Colorado, Aurora

80206

National Jewish Health, Denver

94304

Stanford University, Palo Alto

99508

Providence Alaska Medical Center, Anchorage

02115

Boston Children's Hospital, Boston

Sponsors
All Listed Sponsors
lead

Nivalis Therapeutics, Inc.

INDUSTRY

NCT01746784 - Safety and Pharmacokinetic Study of N6022 in Subjects With Cystic Fibrosis Homozygous for the F508del-CFTR Mutation | Biotech Hunter | Biotech Hunter