Secondary HyperparathyroidismPhase 1NCT01167309
LEO 27847 - Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Secondary Hyperparathyroidism Patients
A Phase 1 study testing LEO 27847 in people with Secondary Hyperparathyroidism, run by LEO Pharma at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Secondary Hyperparathyroidism
- What is being tested?
- LEO 27847
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2010to Dec 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: LEO 27847 - Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Secondary Hyperparathyroidism Patients With Chronic Kidney Disease
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.
- Conditions
- Secondary Hyperparathyroidism
- Being tested
- LEO 27847
- Keywords
- Safety and tolerability of LEO 27847
- Medical subject headings
- Hyperparathyroidism, Secondary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEO 27847Drug
First in patient
| Study group | Role | What they receive |
|---|---|---|
| Part 1 SAD | Active comparator | four diffferent doses Receives: Drug: LEO 27847 |
| Part 2a MAD | Placebo comparator | three doses Receives: Drug: LEO 27847 |
| Part 2b | Active comparator | 0.24 mg LEO 27847 Receives: Drug: LEO 27847 |
| Part 2c | Active comparator | 0.24 mg LEO 27847 Receives: Drug: LEO 27847 |
| Parat 2a MAD | Placebo comparator | one dose Receives: Drug: LEO 27847 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Adverse events, vital signs, ECG, laboratory evaluation, physical examination
Measured: 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
Measured: 7 days after last dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionOct 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary HyperparathyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Expert, Study director, LEO Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01167309
- Sponsor's protocol ID
- LEO 27847-S02
- Status last verified
- Oct 2013
- First submitted
- 2 Jul 2010
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LEO 27847 - Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Secondary Hyperparathyroidism Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01167309
- Acronym / sponsor ID
- LEO 27847-S02
- Conditions
- Secondary Hyperparathyroidism
- Keywords
- Safety and tolerability of LEO 27847
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 22 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1 SAD | Active comparator | Drug: LEO 27847four diffferent doses |
| Part 2a MAD | Placebo comparator | Drug: LEO 27847three doses |
| Part 2b | Active comparator | Drug: LEO 278470.24 mg LEO 27847 |
| Part 2c | Active comparator | Drug: LEO 278470.24 mg LEO 27847 |
| Parat 2a MAD | Placebo comparator | Drug: LEO 27847one dose |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LEO 27847First in patient | Drug | Parat 2a MAD, Part 1 SAD, Part 2a MAD, Part 2b, Part 2c |
Primary outcome
Safety and Tolerability
Time frame: 7 days after last dosing
Adverse events, vital signs, ECG, laboratory evaluation, physical examination
1 secondary outcome
Pharmacokinetics and Pharmacodynamics
Time frame: 7 days after last dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Expert study director
LEO Pharma
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LEO 27847 in people with Secondary Hyperparathyroidism, run by LEO Pharma at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: 7 days after last dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.