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

Completed · Phase 1

Conditions studied: Spinal Muscular Atrophy

In brief

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.

Key facts

Study ID

NCT03988907

Run by

Hoffmann-La Roche

People needed

35

Starts

2019-06-18

Expected to finish

2019-09-29

Last updated by the study team

2020-10-19

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Covance Research Unit - Dallas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.