The Impact of Renal Impairment on the Pharmacokinetic and Pharmacodynamic of LEO 27847

NCT01141179 | Completed Phase 1

• 1 other identifier: LEO 27847-S03
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Renal Impairment

Outcome Measures

Primary Outcomes (1)

• PK parameters

  (AUC, Cmax)in each group of renal impairment

  1 week

Secondary Outcomes (1)

• PD parameters

  1 week

Study Arms (1)

LEO 27847

EXPERIMENTAL

Drug: LEO 27847

Interventions

LEO 27847 DRUG

2 mL (0.1 mg) dose of oral solution

LEO 27847

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• ≥ 50 to ≤ 80 mL/min (Mild Group: 8 subjects),
• ≥ 30 to \< 50 mL/min (Moderate Group: 8 subjects),
• \< 30 mL/min (Severe Group: 8 subjects).

You may not qualify if:

• 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:
• multivitamins or vitamin D taken on a regular basis
• topical products without systemic absorption
• 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

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

Anapharm

Toronto, Ontario, M2P 1N6, Canada

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Richard Larouche, MD

  Anapharm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2010
• First Posted: June 10, 2010
• Study Start: May 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: February 24, 2025

Record last verified: 2013-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)