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

• Status: Completed
• Trial end date: 2019-09-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Midazolam; Risdiplam

Criteria

Inclusion Criteria:

• Healthy participants as defined by the Investigator

• A body mass index (BMI) of 18.0 to 32.0 kg/m2

• Use of adequate contraception methods during the treatment period and until 4 months after last study drug administration. Males must refrain from donating sperm during this same period

• Willingness and ability to complete all aspects of the study

Exclusion Criteria:

• Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study

• History or evidence of any medical condition potentially altering the absorption, metabolism, or elimination of drugs

• Surgical history of the GI tract affecting gastric motility or altering the GI tract

• History or presence of clinically significant ECG abnormalities or cardiovascular disease

• History of malignancy in the past 5 years

• Positive result on human immunodeficiency virus (HIV)-1, HIV-2, hepatitis B virus, or hepatitis C virus

• Donation of blood or blood products for transfusion

• Participation in an investigational drug medicinal product or medical device study within 90 days prior to Screening

• Any clinically significant history of hypersensitivity or allergic reactions

• History of hypersensitivity to midazolam or any other benzodiazepine or its formulation ingredients

For Part 2 participants:

• History of acute angle glaucoma