Extrait

This is a 2 parts study to determine whether LHW090 displays the clinical safety profile to support further development in patients with moderately impaired renal function. Objective of Part 1 of the study : To assess the safety and tolerability of doses of LHW090 in patients with moderate renal impairment to inform design of Part 2. An intra-patient dose escalation scheme will be employed starting at a 25 mg once daily dose for the first four day cycle, and then the dose will be escalated to 50 mg once daily for the next four days and then 100 mg once daily for four days. - Objective of Part 2 of the study : To assess the renal safety of LHW090 in patients with moderate renal impairment dosed at 100 mg once daily for 4 weeks.

Critère d'inclusion

• Moderate Renal Impairment

Liens

• euctr