Status:
COMPLETED
Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants
Lead Sponsor:
Principia Biopharma, a Sanofi Company
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
Primary Objective: * To evaluate the impact of food on the pharmacokinetics (PK) of rilzabrutinib following single oral doses to healthy subjects. * To evaluate the impact of formulation on the PK of...
Detailed Description
The total study duration is approximately 43 days for each participant, including a screening period of 2 to 28 days, treatment period of 12 days, and follow-up of 3 days
Eligibility Criteria
Inclusion
- Inclusion criteria :
- \- Participants who are overtly healthy as determined by medical evaluation
- Body mass index (BMI) within the range ≥18 and ≤31 kg/m2 (inclusive) and a minimum body weight of 45 kg.
- Female participant is eligible to participate if she is not pregnant or breastfeeding
- Male participants are eligible to participate if they agree to refrain from donating sperm and use contraception/barrier or be abstinent from intercourse
- Exclusion criteria:
- COVID-19 infection, positive test result for human immunodeficiency virus (HIV), hepatitis B virus or hepatitis C virus antibody
- Use of any prescription or over-the-counter (OTC) medication, herbal products, or dietary supplements within 7 days
- Participation in another clinical trial of a drug or device whereby the last investigational drug/device administration is within 30 days or 5 half-lives, whichever is longer, prior to the first dose of study drug.
- Clinically significant abnormal in vital signs. - Any specific situation during study implementation/course that may rise ethics considerations.
- The above information is not intended to contain all considerations relevant to a subject's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
April 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 21 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04748926
Start Date
April 7 2021
End Date
May 21 2021
Last Update
September 23 2025
Active Locations (1)
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1
Investigational Site
Adelaide, Australia, 5000