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

LEO Pharma

Status and phase: Completed; Phase 1

Conditions: Secondary Hyperparathyroidism

Treatments: Drug: LEO 27847

Study type: Interventional

Funder types: Industry

Identifiers

NCT01167309

LEO 27847-S02

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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72 participants in 5 patient groups, including a placebo group

Part 1 SAD

Active Comparator group

Description:

four diffferent doses

Treatment:

Drug: LEO 27847

Part 2a MAD

Placebo Comparator group

Description:

three doses

Treatment:

Drug: LEO 27847

Part 2b

Active Comparator group

Description:

0.24 mg LEO 27847

Treatment:

Drug: LEO 27847

Part 2c

Active Comparator group

Description:

0.24 mg LEO 27847

Treatment:

Drug: LEO 27847

Parat 2a MAD

Placebo Comparator group

Description:

one dose

Treatment:

Drug: LEO 27847