NCT04749914

A Study of Lasmiditan in Healthy Volunteers

An Open-Label, 2-Part Study to Investigate the Effect of Lasmiditan on the Pharmacokinetics of Dabigatran and Rosuvastatin in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The main purpose of the study is to investigate the blood concentrations of dabigatran etexilate and rosuvastatin when taken alone compared to when taken together with lasmiditan in healthy participants. The safety and tolerability of dabigatran etexilate or rosuvastatin in combination with lasmiditan will also be evaluated in healthy participants. The study has two parts. Each part will last up to 17 days, not including screening.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Lasmiditan	Administered orally.
DRUG	Dabigatran Etexilate	Administered orally.
DRUG	Rosuvastatin	Administered orally.

Timeline

• Start date: 2021-02-15
• Primary completion: 2021-07-06
• Completion: 2021-07-06
• First posted: 2021-02-11
• Last updated: 2024-02-01
• Results posted: 2024-02-01

Locations

1 site across 1 country: Singapore

Regulatory

• FDA-regulated drug study