Study to Assess the Blood Concentrations and Actions of Recombinant Human Parathyroid Hormone (rhPTH [1-84]) When Given Once and Twice Daily to Participants With Hypoparathyroidism

PHASE1CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

April 3, 2017

Primary Completion Date

March 8, 2019

Study Completion Date

March 8, 2019

Conditions
Hypoparathyroidism
Interventions
DRUG

25mcg rhPTH(1-84)

Participants will receive rhPTH(1-84) as twice-daily regimen (12 hours apart) of two 25mcg doses without calcium in cohort 1 and with calcium in cohort 3.

DRUG

50mcg rhPTH(1-84)

Participants will receive rhPTH(1-84) as twice daily regimen (12 hours apart) of two 50mcg doses without calcium in cohort 2 and with calcium in cohort 4

DRUG

100mcg rhPTH(1-84)

Participants will receive rhPTH(1-84) as once-daily regimen of one 100 mcg dose without calcium in cohort 1 and 2 and with calcium in cohort 3 and 4 in the morning.

Trial Locations (15)

1083

Semmelweis Egyetem, Budapest

6720

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, Szeged

7624

Pécsi Tudományegyetem, Pécs

8200

Aarhus Universitetshospital, Aarhus N

10032

Columbia University Medical Center, New York

19107

Thomas Jefferson University, Philadelphia

37920

New Orleans Center for Clinical Research (NOCCR) - Knoxville, Knoxville

43201

Ohio State University Wexner Medical Center, Columbus

46202

Indiana University, Indianapolis

55905

Mayo Clinic - PPDS, Rochester

70006

Crescent City Clinical Research Center, LLC, Metairie

91606

Providence Clinical Research, North Hollywood

40536-0298

University Of Kentucky School of Medicine, Lexington

02114

Massachusetts General Hospital, Boston

G1V 4G2

CHU de Quebec-Universite Laval, Québec

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY