NCT03150108 is a Phase 1 clinical trial of rhPTH(1-84) in Hypoparathyroidism, sponsored by Shire.

Who is sponsoring NCT03150108?

NCT03150108 is sponsored by Shire.

What drugs are being tested in NCT03150108?

Interventions in NCT03150108: rhPTH(1-84), rhPTH(1-84), rhPTH(1-84).

What condition does NCT03150108 study?

NCT03150108 studies Hypoparathyroidism.

Is NCT03150108 still recruiting?

NCT03150108 is currently completed. Last updated 8 June 2021.

Are results published for NCT03150108?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-06-08 · How we verify

NCT03150108

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of rhPTH(1-84) in Japanese Healthy Subjects Compared With Matched Caucasian Healthy Adult Subjects

Completed Phase 1 Results posted Last updated 8 June 2021

What this trial tests

Phase 1 trial testing rhPTH(1-84) in Hypoparathyroidism in 24 participants. Completed in 26 June 2017.

Timeline

16 May 2017

Primary endpoint
26 June 2017

26 June 2017

Quick facts

Lead sponsor	Shire
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	16 May 2017
Primary completion	26 June 2017
Estimated completion	26 June 2017
Sites	1 location across United States

Drugs / interventions tested

rhPTH(1-84)
rhPTH(1-84)
rhPTH(1-84)

Conditions studied

Hypoparathyroidism — all drugs for Hypoparathyroidism →

Sponsor

Shire — full company profile →

Who can join

Adults 18 to 65, any sex, with Hypoparathyroidism. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Baseline-adjusted Cmax of PTH(1-84) Primary · 30 and 90 minutes (min) Pre-dose, 10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours (h) Post-dose

Baseline-adjusted maximum observed drug concentration (Cmax) of PTH(1-84) in plasma was reported. The dispersion measure Geometric Coefficient of Variation was reported in percent (%).

Group	Value	95% CI
Non-Hispanic Caucasians: 100 mcg rhPTH(1-84)	295.662	± 41.66
Participants of Japanese Descent: 100 mcg rhPTH(1-84)	330.820	± 29.44
Participants of Japanese Descent: 50 mcg rhPTH(1-84)	175.468	± 35.29
Participants of Japanese Descent: 25 mcg rhPTH(1-84)	99.708	± 22.02

Baseline-adjusted Tmax of PTH(1-84) Primary · 30 and 90 min Pre-dose,10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h Post-dose

Baseline-adjusted time to reach maximum observed drug concentration (Tmax) of PTH(1-84) in plasma was reported.

Group	Value	95% CI
Non-Hispanic Caucasians: 100 mcg rhPTH(1-84)	0.415	0.17 – 3.00
Participants of Japanese Descent: 100 mcg rhPTH(1-84)	1.000	0.17 – 4.00
Participants of Japanese Descent: 50 mcg rhPTH(1-84)	1.385	0.50 – 2.50
Participants of Japanese Descent: 25 mcg rhPTH(1-84)	1.240	0.17 – 2.00

Baseline-adjusted AUC(Last) of PTH(1-84) in Plasma Primary · 30 and 90 min Pre-dose,10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h Post-dose

Baseline-adjusted area under the curve from the time of dosing to the last measurable concentration (AUC(last)) of PTH(1-84) was reported. The dispersion measure Geometric Coefficient of Variation was reported in percent (%).

Group	Value	95% CI
Non-Hispanic Caucasians: 100 mcg rhPTH(1-84)	1037.63	± 31.0
Participants of Japanese Descent: 100 mcg rhPTH(1-84)	1027.81	± 32.6
Participants of Japanese Descent: 50 mcg rhPTH(1-84)	602.06	± 30.6
Participants of Japanese Descent: 25 mcg rhPTH(1-84)	255.67	± 28.7

Baseline-adjusted AUC(0-8) of PTH(1-84) in Plasma Primary · 30 and 90 min Pre-dose,10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h Post-dose

Baseline-adjusted area under the concentration versus time curve from the time of dosing to 8 hours post dose (AUC(0-8)) of PTH(1-84) was reported. The dispersion measure Geometric Coefficient of Variation was reported in percent (%).

Group	Value	95% CI
Non-Hispanic Caucasians:100 mcg rhPTH(1-84)	956.63	± 32.8
Participants of Japanese Descent: 100 mcg rhPTH(1-84)	1033.62	± 31.4
Participants of Japanese Descent: 50 mcg rhPTH(1-84)	554.23	± 30.8
Participants of Japanese Descent: 25 mcg rhPTH(1-84)	248.38	± 19.7

Baseline-adjusted AUC(0-inf) of PTH(1-84) in Plasma Primary · 30 and 90 min Pre-dose,10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h Post-dose

Baseline-adjusted area under the concentration versus time curve extrapolated to infinity (AUC(0-inf)) of PTH(1-84) was reported. The dispersion measure Geometric Coefficient of Variation was reported in percent (%).

Group	Value	95% CI
Non-Hispanic Caucasians: 100 mcg rhPTH(1-84)	1028.29	± 37.0
Participants of Japanese Descent: 100 mcg rhPTH(1-84)	1039.34	± 29.8
Participants of Japanese Descent: 50 mcg rhPTH(1-84)	589.25	± 31.6
Participants of Japanese Descent: 25 mcg rhPTH(1-84)	249.51	± 21.9

Baseline- Adjusted % of AUC(0-Inf) Extra of PTH(1-84) in Plasma Primary · 30 and 90 min Pre-dose,10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h Post-dose

Baseline-adjusted % of AUC extrapolated from the last measurable concentration to infinity over (AUC(0-Inf)) of PTH(1-84) in plasma was reported. The dispersion measure Geometric Coefficient of Variation was reported in percent (%).

Group	Value	95% CI
Non-Hispanic Caucasians:100 mcg rhPTH(1-84)	1.416	± 198.59
Participants of Japanese Descent: 100 mcg rhPTH(1-84)	0.932	± 330.55
Participants of Japanese Descent: 50 mcg rhPTH(1-84)	1.555	± 173.86
Participants of Japanese Descent: 25 mcg rhPTH(1-84)	3.015	± 135.99

Baseline-adjusted Lambda_z of PTH(1-84) in Plasma Primary · 30 and 90 min Pre-dose,10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h Post-dose

Baseline-adjusted Lambda z associated with the terminal (log-linear) portion of the curve for PTH(1-84) in plasma was reported. The dispersion measure Geometric Coefficient of Variation was reported in percent (%).

Group	Value	95% CI
Non-Hispanic Caucasians:100 mcg rhPTH(1-84)	0.4496	± 67.730
Participants of Japanese Descent: 100 mcg rhPTH(1-84)	0.6672	± 35.835
Participants of Japanese Descent: 50 mcg rhPTH(1-84)	0.5714	± 65.437
Participants of Japanese Descent: 25 mcg rhPTH(1-84)	0.8277	± 57.118

Baseline-adjusted t1/2 of PTH(1-84) in Plasma Primary · 30 and 90 min Pre-dose,10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h Post-dose

Baseline-adjusted Terminal Half-life (t1/2) of PTH(1-84) in plasma was reported.

Group	Value	95% CI
Non-Hispanic Caucasians:100 mcg rhPTH(1-84)	1.390	0.68 – 4.74
Participants of Japanese Descent: 100 mcg rhPTH(1-84)	1.060	0.65 – 1.71
Participants of Japanese Descent: 50 mcg rhPTH(1-84)	1.020	0.69 – 3.57
Participants of Japanese Descent: 25 mcg rhPTH(1-84)	0.950	0.30 – 1.88

Baseline-adjusted CL/F of PTH(1-84) in Plasma Primary · 30 and 90 min Pre-dose,10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h Post-dose

Baseline-adjusted apparent clearance (CL/F) of PTH(1-84) in plasma was reported. The dispersion measure Geometric Coefficient of Variation was reported in percent (%).

Group	Value	95% CI
Non-Hispanic Caucasians:100 mcg rhPTH(1-84)	97.25	± 37.0
Participants of Japanese Descent: 100 mcg rhPTH(1-84)	96.22	± 29.8
Participants of Japanese Descent: 50 mcg rhPTH(1-84)	84.84	± 31.6
Participants of Japanese Descent: 25 mcg rhPTH(1-84)	100.18	± 21.9

Baseline-adjusted Vdz/F of PTH(1-84) in Plasma Primary · 30 and 90 min Pre-dose,10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h Post-dose

Baseline-adjusted apparent volume of distribution (Vdz/F) of PTH(1-84) in plasma was reported. The dispersion measure Geometric Coefficient of Variation was reported in percent (%).

Group	Value	95% CI
Non-Hispanic Caucasians:100 mcg rhPTH(1-84)	216.30	± 93.9
Participants of Japanese Descent: 100 mcg rhPTH(1-84)	144.18	± 54.7
Participants of Japanese Descent: 50 mcg rhPTH(1-84)	148.50	± 71.9
Participants of Japanese Descent: 25 mcg rhPTH(1-84)	121.02	± 57.7

Original Cmax of PTH(1-84) in Plasma Secondary · 30 and 90 min Pre-dose,10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h Post-dose

Original maximum observed drug concentration (Cmax) of PTH(1-84) in plasma was reported. The dispersion measure Geometric Coefficient of Variation was reported in percent (%).

Group	Value	95% CI
Non-Hispanic Caucasians:100 mcg rhPTH(1-84)	324.43	± 36.2
Participants of Japanese Descent: 100 mcg rhPTH(1-84)	365.52	± 27.3
Participants of Japanese Descent: 50 mcg rhPTH(1-84)	206.05	± 29.6
Participants of Japanese Descent: 25 mcg rhPTH(1-84)	129.74	± 21.1

Original Tmax of PTH(1-84) Secondary · 30 and 90 min Pre-dose,10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h Post-dose

The original time to reach maximum observed drug concentration (Tmax) of PTH(1-84) in plasma was reported.

Group	Value	95% CI
Non-Hispanic Caucasians:100 mcg rhPTH(1-84)	0.415	0.17 – 3.00
Participants of Japanese Descent: 100 mcg rhPTH(1-84)	1.000	0.17 – 4.00
Participants of Japanese Descent: 50 mcg rhPTH(1-84)	1.385	0.50 – 2.50
Participants of Japanese Descent: 25 mcg rhPTH(1-84)	1.240	0.17 – 2.00

Adverse events — posted to ClinicalTrials.gov

Time frame: From start of study drug administration to follow-up (up to 40 days). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Non-Hispanic Caucasians:100 mcg rhPTH(1- 84)

Serious: 0/12 (0%)

Deaths: 0/12

Participants of Japanese Descent: 100 mcg rhPTH(1-84)

Serious: 0/12 (0%)

Deaths: 0/12

Participants of Japanese Descent: 50 mcg rhPTH(1-84)

Serious: 0/12 (0%)

Deaths: 0/12

Participants of Japanese Descent: 25 mcg rhPTH(1-84)

Serious: 0/12 (0%)

Deaths: 0/12

Other adverse events (11 terms — click to expand)

Reaction	System	Non-Hispanic Caucasians:10…	Participants of Japanese D…	Participants of Japanese D…	Participants of Japanese D…
Nausea	Gastrointestinal disorders	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Sunburn	Injury, poisoning and procedural complications	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—
Somnolence	Nervous system disorders	—	—	—	—
Fatigue	General disorders	—	—	—	—
Influenza like illness	General disorders	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—

Data from ClinicalTrials.gov NCT03150108 adverse events section.

Sponsor's own description

The purpose of this study is to compare how rhPTH(1-84) affects the body between healthy adults of Japanese descent and matched, healthy Caucasian adults.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of rhPTH(1-84)

Trials testing the same drug.

NCT03878953 — A Clinical Study of rhPTH(1-84) Treatment in Japanese Participants With Chronic Hypoparathyroidism · Phase 3 · withdrawn
NCT05137730 — A Study of Relative Bioavailability of a New Formulation Compared With the Approved Formulation of rhPTH [1-84] and to F · Phase 1 · completed
NCT03364738 — Safety and Efficacy Study of rhPTH(1-84) in Subjects With Hypoparathyroidism · Phase 3 · terminated
NCT02910466 — A Study of Extended Use of Recombinant Human Parathyroid Hormone (rhPTH(1-84)) in Hypoparathyroidism · Phase 4 · completed

Other recruiting trials for Hypoparathyroidism

Currently open trials in the same condition.

NCT06961071 — Parathyroid Allotransplant for Treatment of Hypoparathyroidism · Phase 1, PHASE2 · recruiting
NCT07083557 — Routine Validation and Reproducibility Testing of Laboratory Assays and Research Techniques Used for Endocrine, Cardiome · recruiting
NCT07530705 — Efficacy and Safety of Subcutaneous Injection of XH-02 in the Treatment of Adult Hypoparathyroidism · Phase 1, PHASE2 · recruiting
NCT07197450 — Efficacy and Safety of XH02 for the Treatment of Hypoparathyroidism · EARLY_PHASE1 · recruiting
NCT06645899 — Institution of an Italian Multicenter Database of Patients Affected by Hypoparathyroidism or Pseudohypoparathyroidism · recruiting

Other Shire trials

Trials by the same sponsor.

NCT05067868 — A Study of Replagal in Children and Adults With Fabry Disease in India · Phase 4 · recruiting
NCT03878953 — A Clinical Study of rhPTH(1-84) Treatment in Japanese Participants With Chronic Hypoparathyroidism · Phase 3 · withdrawn
NCT04840667 — A Study of Replagal in Treatment-naïve Adults With Fabry Disease · Phase 3 · terminated
NCT04429984 — Post Marketing Surveillance (PMS) Study for Velaglucerase Alfa (VPRIV) in India · completed
NCT04440488 — ARALAST NP Alpha-1 Lung Density Chronic Obstructive Pulmonary Disease-Emphysema (COPD-E) Study · Phase 4 · withdrawn

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03150108 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Shire
Last refreshed: 8 June 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03150108.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT03150108

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of rhPTH(1-84)

Other recruiting trials for Hypoparathyroidism

Other Shire trials

Verify against primary sources