NCT01167309

Brief Summary

The purpose of this trial is to determine the safety and tolerability of ascending single and multiple oral doses of LEO 27847 in secondary hyperparathyroidism patients.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2010

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 2, 2010

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 22, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

February 24, 2025

Status Verified

October 1, 2013

Enrollment Period

1.3 years

First QC Date

July 2, 2010

Last Update Submit

February 21, 2025

Conditions

Secondary Hyperparathyroidism

Keywords

Safety and tolerability of LEO 27847

Outcome Measures

Primary Outcomes (1)

  • Safety and Tolerability

    Adverse events, vital signs, ECG, laboratory evaluation, physical examination

    7 days after last dosing

Secondary Outcomes (1)

  • Pharmacokinetics and Pharmacodynamics

    7 days after last dosing

Study Arms (5)

Part 1 SAD

ACTIVE COMPARATOR

four diffferent doses

Drug: LEO 27847

Part 2a MAD

PLACEBO COMPARATOR

three doses

Drug: LEO 27847

Part 2b

ACTIVE COMPARATOR

0.24 mg LEO 27847

Drug: LEO 27847

Part 2c

ACTIVE COMPARATOR

0.24 mg LEO 27847

Drug: LEO 27847

Parat 2a MAD

PLACEBO COMPARATOR

one dose

Drug: LEO 27847

Interventions

LEO 27847DRUG

First in patient

Parat 2a MADPart 1 SADPart 2a MADPart 2bPart 2c

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 to 75 years (inclusive) at screening.
  • Patients with body mass index within 18 to 34 kg/m2 (inclusive).
  • Haemoglobin is stable (≥9 g/dL or 5.6 mmol/L)
  • Parathyroid hormone (PTH) is ≥200 pg/mL and \<800 pg/mL.
  • Screening serum albumin is ≥30 g/L.
  • C-reactive protein \<25 mg/L.

You may not qualify if:

  • Adjustment of vitamin D sterols within 14 days before the screening visit and patients for whom adjustment of vitamin D sterols is planned from screening until end of study.
  • Adjustment of calcium supplements within 14 days before the screening visit and patients for whom adjustment of calcium supplements is planned from screening until end of study.
  • Adjustment of phosphate binder within 14 days before the screening visit and patients or whom adjustment of phosphate binder is planned from screening until end of study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CRS Clinical Research Services Kiel GmbH

Kiel, 24105, Germany

Location

Centralny Szpital Kliniczny MON

Warsaw, 04-141, Poland

Location

MeSH Terms

Conditions

Hyperparathyroidism, Secondary

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System Diseases

Study Officials

  • Medical Expert

    LEO Pharma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2010

First Posted

July 22, 2010

Study Start

June 1, 2010

Primary Completion

October 1, 2011

Study Completion

December 1, 2011

Last Updated

February 24, 2025

Record last verified: 2013-10

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)DE(1)