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CompletedNCT01167309Updated Feb 24, 2025

LEO 27847 - Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Secondary Hyperparathyroidism Patients

A Phase 1 interventional study of LEO 27847 in Secondary Hyperparathyroidism, sponsored by LEO Pharma. Completed at 2 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-02-24.

Sponsored by LEO Pharma · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Secondary Hyperparathyroidism

Keywords

  • Safety and tolerability of LEO 27847
03

In context

Hyperparathyroidism, Secondary

190 studies on the registry are indexed under Hyperparathyroidism, Secondary; 15 are open to participants now.

This study's enrollment of 72 is above the median of 61 across 149 interventional studies indexed under Hyperparathyroidism, Secondary.

Browse Hyperparathyroidism, Secondary studies →

Lead sponsor

LEO Pharma is the lead sponsor of 225 studies on the registry; 5 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 24 (77%) have results posted.

Browse LEO Pharma studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
72 participants (actual)

Study arms

  • Active comparator
    Part 1 SAD

    four diffferent doses

    Drug: LEO 27847

  • Placebo comparator
    Part 2a MAD

    three doses

    Drug: LEO 27847

  • Active comparator
    Part 2b

    0.24 mg LEO 27847

    Drug: LEO 27847

  • Active comparator
    Part 2c

    0.24 mg LEO 27847

    Drug: LEO 27847

  • Placebo comparator
    Parat 2a MAD

    one dose

    Drug: LEO 27847

Interventions

06

What researchers measure

Primary outcomes

  1. Safety and Tolerability

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

    Time frame: 7 days after last dosing

Secondary outcomes

  1. Pharmacokinetics and Pharmacodynamics

    LEO 27847, PTH, calcium, Vitamin D and phosphate in blood. LEO 27847 in urine

    Time frame: 7 days after last dosing

07

Study locations

2 sites
  • CRS Clinical Research Services Kiel GmbH
    Kiel, 24105, Germany
  • Centralny Szpital Kliniczny MON
    Warsaw, 04-141, Poland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01167309
Lead sponsor
LEO Pharma
Responsible party
Sponsor
First posted
Jul 22, 2010
Start date
Jun 2010
Primary completion
Oct 2011
Completion
Dec 2011
Last update
Feb 24, 2025

Study contacts

Medical Expert
study director · LEO Pharma

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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