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

NCT ID: NCT01167309

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2011-12-31

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.

Conditions

Secondary Hyperparathyroidism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Part 1 SAD

four diffferent doses

Group Type: ACTIVE_COMPARATOR

LEO 27847

Intervention Type: DRUG

First in patient

Part 2a MAD

three doses

Group Type: PLACEBO_COMPARATOR

LEO 27847

Intervention Type: DRUG

First in patient

Part 2b

0.24 mg LEO 27847

Group Type: ACTIVE_COMPARATOR

LEO 27847

Intervention Type: DRUG

First in patient

Part 2c

0.24 mg LEO 27847

Group Type: ACTIVE_COMPARATOR

LEO 27847

Intervention Type: DRUG

First in patient

Parat 2a MAD

one dose

Group Type: PLACEBO_COMPARATOR

LEO 27847

Intervention Type: DRUG

First in patient

Interventions

LEO 27847

First in patient

Intervention Type: DRUG

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LEO Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Expert

Role: STUDY_DIRECTOR

LEO Pharma

Locations

CRS Clinical Research Services Kiel GmbH

Kiel, , Germany

Centralny Szpital Kliniczny MON

Warsaw, , Poland

Countries

Germany; Poland

Other Identifiers

LEO 27847-S02

Identifier Type: -

Identifier Source: org_study_id