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

CompletedPhase 1

Sponsor: Hoffmann-La Roche

Conditions: Spinal Muscular Atrophy

Interventions: Risdiplam, Midazolam

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 55 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility 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

Locations (1)

Dallas, Texas, United States