NCT03988907

A Drug-drug Interaction Study With Risdiplam Multiple Dose and Midazolam in Healthy Participants

A Phase I, 2-Part, Open-Label Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Risdiplam and the Effect of Risdiplam on the Pharmacokinetics of Midazolam Following Oral Administration in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This will be a Phase I, 2-part, open-label, non-randomized study to investigate the safety, tolerability, and pharmacokinetics (PK) of a multiple-dosing regimen of risdiplam (Part 1) and the effect of risdiplam on the PK of midazolam (Part 2) following oral administration in healthy adult male and female participants.

Conditions

• Spinal Muscular Atrophy

Interventions

Type	Name	Description
DRUG	Risdiplam	Part 1: a dose of 5 milligram (mg) risdiplam QD ; Part 2: precise dose will be based on Part 1 results
DRUG	Midazolam	single dose administration of 2 mg midazolam

Timeline

• Start date: 2019-06-18
• Primary completion: 2019-09-29
• Completion: 2019-09-29
• First posted: 2019-06-18
• Last updated: 2020-10-19
• Results posted: 2020-10-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study