Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study will investigate the impact of reduced renal function on the pharmacokinetic and pharmacodynamic profile of LEO 27847. Volunteers with different degrees of renal impairment will be administered one dose of the investigational drug and then followed until investigational drug is eliminated from the body.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEO 27847 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEO 27847 | Drug | 2 mL (0.1 mg) dose of oral solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters | (AUC, Cmax)in each group of renal impairment | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| PD parameters | (Calcium, phosphate, PTH), Vitamin D in each group of renal impairment | 1 week |
Not provided
Main Inclusion Criteria:
Male and/or non-childbearing potential female, 18 years of age and older, healthy or with stable renal impairment (deemed stable by the referring physician for at least the last 4 weeks and not expected to change significantly during the next 3 months)
BMI ≥18.0 and ≤ 42 kg/m2
Patients with stable concomitant medical conditions
Healthy subjects or patients with a creatinine clearance (at the time of screening) estimated using the formula of Cockcroft and Gault within the range of:
Main Exclusion Criteria:
Patients with renal transplants or currently on haemodialysis or peritoneal dialysis
Clinically significant illness or surgery within 4 weeks prior to dosing
Clinically significant ECG abnormalities or vital sign abnormalities at screening
History of stroke, cerebrovascular disorder, coronary angioplasty and coronary bypass graft
Clinically significant history or presence of any gastrointestinal pathology
Use of medications other than their stable medications within 14 days prior to administration of investigational product or over-the-counter products within 7 days prior to administration of investigational product, except for:
Hemoglobin ≤ 90 g/L
Serum total calcium (adjusted for albumin) level < 2.25 mmol/L
Clinically significant history of congestive heart failure, cardiac dysfunction or liver disease
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Richard Larouche, MD | Anapharm | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anapharm | Toronto | Ontario | M2P 1N6 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |