Study of Oral Lasmiditan in Participants With Normal and Impaired Renal Function
Status:
Completed
Trial end date:
2017-06-02
Target enrollment:
Participant gender:
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.