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The Impact of Renal Impairment on the Pharmacokinetic and Pharmacodynamic of LEO 27847 | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT01141179•LEO Pharma

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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:
•* ≥ 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).

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:
•* 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
+1 more criteria

Locations (1)

Anapharm

Toronto, Ontario, Canada

Key Dates

Start Date

May 1, 2010

Primary Completion Date

February 1, 2011

Completion Date

February 1, 2011

Last Updated

February 24, 2025

Enrollment

ACTUAL participants

Conditions

Renal Impairment

Interventions

LEO 27847

DRUG

Investigation of the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD2373)

NCT07154901

Renal Impairment

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ACTIVE_NOT_RECRUITINGPHASE1

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NCT07165015

Renal ImpairmentHealthy+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Investigation of the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD2373)

A Study of Pharmacokinetics and Safety of LY3537031 in Participants With Normal Renal Function and Participants With Renal Impairment

A Study to Test How BI 456906 is Taken up in the Blood of People With and Without Kidney Problems

A Study of RG002C0106 Injection in Adult Participants With Normal Renal Function and Mild-to-Moderate Renal Impairment

A Study to Investigate the Pharmacokinetics, Safety and Tolerability of AZD5462 in Participants With Renal Impairment

DESIR. Evaluation of the Pre-therapeutic Activity of Dihydropyrimidine dEShydrogenase (DPD) in Patients With Cancer and/or Renal Failure