Study Assessing the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interactions of PTI-801 in Healthy Volunteers, and Safety, Tolerability, and Pharmacokinetics of PTI-801 in Subjects With Cystic Fibrosis

PHASE1CompletedINTERVENTIONAL
Enrollment

171

Participants

Timeline

Start Date

April 10, 2017

Primary Completion Date

February 27, 2020

Study Completion Date

February 27, 2020

Conditions
Healthy VolunteerCystic Fibrosis
Interventions
DRUG

PTI-801

Active

DRUG

Placebo

Placebo

DRUG

PTI-808

Active

DRUG

Placebo

Placebo

Trial Locations (38)

2100

University of Copenhagen Rigshospitalet, Copenhagen

10001

Columbia University Medical Center, New York

10003

Mount Sinai Beth Israel, New York

10117

Charite - Campus Virchow-Klinikum, Berlin

10595

New York Medical College, Valhalla

15244

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

19104

Children's Hospital of Philadelphia, Philadelphia

23298

Virginia Commonwealth University, Richmond

27710

Duke University Health System, Durham

29425

Medical University of South Carolina, Charleston

32610

University of Florida College of Medicine, Gainesville

32803

Central Florida Pulmonary Group, Altamonte Springs

33136

University of Miami Health System, Miami

35233

University of Alabama at Birmingham, Birmingham

43205

Nationwide Children's Hospital, Columbus

43606

Toledo Children's Hospital, Toledo

44308

Akron Children's Hospital, Akron

48109

University of Michigan Health System, Ann Arbor

52242

University of Iowa, Iowa City

60611

Northwestern University Memorial Hospital, Chicago

61637

OSF Saint Francis Medical Center, Peoria

64108

Children's Mercy Kansas City, Kansas City

68198

University of Nebraska Medical Center, Omaha

73112

Santiago Reyes, M.D. P.C., Oklahoma City

75708

University of Texas Health Science Center at Tyler, Tyler

78209

ICON Early Phase Services, San Antonio

80206

National Jewish Health, Denver

83712

St. Luke's CF Center of Idaho, Boise

84132

University of Utah, Salt Lake City

89107

Children's Lung Specialists, Las Vegas

94305

Stanford University Medical Center, Stanford

99508

Providence Alaska Medical Center, Anchorage

04102

Maine Medical Center, Portland

02114

Massachusetts General Hospital, Boston

02115

Boston Children's Hospital, Boston

V6Z1Y6

St. Paul's Hospital, Vancouver

G1V 4G5

Institut Universitaire de Cardiologie et de Pneumologie de Quebec, Québec

141 86

Stockholm CF Center, Stockholm

All Listed Sponsors
lead

Proteostasis Therapeutics, Inc.

INDUSTRY

NCT03140527 - Study Assessing the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interactions of PTI-801 in Healthy Volunteers, and Safety, Tolerability, and Pharmacokinetics of PTI-801 in Subjects With Cystic Fibrosis | Biotech Hunter | Biotech Hunter