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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-18

Study Completion Date

2019-09-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Spinal Muscular Atrophy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1

Participants will receive a dose of 5 milligram (mg) risdiplam once daily (QD) for 14 consecutive days

Group Type EXPERIMENTAL

Risdiplam

Intervention Type DRUG

Part 1: a dose of 5 milligram (mg) risdiplam QD ; Part 2: precise dose will be based on Part 1 results

Part 2

All study participants will receive a single oral dose of 2 mg midazolam on Day 1. On Day 3, the 14-day QD treatment period with risdiplam will begin. The precise dose will be based on the results of Part 1, with single dose administration of 2 mg midazolam again on Day 15 (1 hour after the thirteenth dose of risdiplam)

Group Type EXPERIMENTAL

Risdiplam

Intervention Type DRUG

Part 1: a dose of 5 milligram (mg) risdiplam QD ; Part 2: precise dose will be based on Part 1 results

Midazolam

Intervention Type DRUG

single dose administration of 2 mg midazolam

Interventions

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Risdiplam

Part 1: a dose of 5 milligram (mg) risdiplam QD ; Part 2: precise dose will be based on Part 1 results

Intervention Type DRUG

Midazolam

single dose administration of 2 mg midazolam

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes