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

Study Identifier:
BP41361
ClinicalTrials.gov Identifier:
NCT03988907
EudraCT Identifier:
N/A
EU CT Number:
N/A
Sponsor:
Hoffmann-La Roche
Study Complete

Trial Results

Study Protocol
Available Languages: English
View PDF
Statistical Analysis Plan
Available Languages: English
View PDF

Study Details

Medical Condition
  • All Spinal Muscular Atrophies
Study Drug
  • Drug: Risdiplam
  • Drug: Midazolam
Date
Jun 2019 - Sep 2019
Phase 1
Phase 2
Phase 3
Phase 4
Patient Requirements
Sex: Female & Male
Age: 18 - 55 Years
Requirements Information
Inclusion and Exclusion 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

Protocol 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.

Trial Locations

Location
Status
Location
Covance Research Unit - Dallas
Dallas, Texas, United States, 75247
Status
N/A

Contact Cure SMA

User Information

If you have general questions regarding clinical trials or would like to be added to the Cure SMA mailing list to receive communications regarding future registries, studies, or clinical trials in SMA, please fill out the form below. Fields marked with an asterisk (*) are mandatory.

  • Disability Advocate who does not have SMA
  • I am a healthcare provider
  • I am a researcher
  • I have no direct connection to SMA
  • I have SMA
  • I lost a child to SMA
  • My child has SMA
  • Someone close to me has/had SMA
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Chile
  • China
  • Colombia
  • Croatia
  • Czech Republic
  • Denmark
  • Estonia
  • France
  • Germany
  • Greece
  • Hong Kong
  • Hungary
  • India
  • Ireland
  • Israel
  • Italy
  • Japan
  • Lebanon
  • Malaysia
  • Mexico
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Puerto Rico
  • Qatar
  • Republic of Korea
  • Romania
  • Russian Federation
  • Saudi Arabia
  • Serbia
  • Singapore
  • South Africa
  • Spain
  • Sweden
  • Switzerland
  • Taiwan, Province of China
  • Thailand
  • Ukraine
  • United Kingdom
  • United States
  • Vietnam
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.