Study of Oral Lasmiditan in Participants With Normal and Impaired Renal Function

Migraine Clinical Trial

Official title: A Phase I, Multicenter, Open-Label, Parallel-Group Adaptive Pharmacokinetic Single Dose Study of Oral Lasmiditan in Subjects With Normal and Impaired Renal Function

Status Completed

Clinical Trial Summary

This is a multi-center, open-label, non-randomized, parallel-group, adaptive, single dose study.

This study will enroll up to 32 participants using an adaptive design that can include up to 3 groups of 8 participants with different degree of renal impairment and one group of 8 control participants with normal renal function.

Screening data will be reviewed to determine participant eligibility. Participants who meet all inclusion criteria and none of the exclusion criteria will be entered in the study.

First, approximately 16 participants will be enrolled with severe renal impairment and matched participants with normal renal function. There will be 8 participants in each of the following groups based on renal function at screening:

• Group 1: Healthy participants with normal renal function (estimated glomerular filtration rate [eGFR] ≥ 90 milliliters per minute per 1.73 meters squared [mL/min/1.73m²])

• Group 2: Severe renal impairment participants (eGFR < 30 mL/min/1.73m²) Based on safety and pharmacokinetic (PK) results from participants with severe renal impairment (Group 2), Group 3 (Moderate Renal Impairment) and Group 4 (Mild Renal Impairment) will be enrolled if substantial change in the exposure of lasmiditan is observed in participants with severe renal impairment.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Migraine
• Renal Insufficiency

• NCT number: NCT03009162
• Study type: Interventional
• Source: Eli Lilly and Company
• Status: Completed
• Phase: Phase 1
• Start date: April 1, 2017
• Completion date: June 2, 2017