Healthy Volunteers
Conditions
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 rilzabrutinib following single oral doses to healthy subjects Secondary Objective: \- To assess the safety and tolerability of single oral doses of rilzabrutinib administered under fasted and fed conditions
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
Interventions
Pharmaceutical form: caplet Route of administration: oral
Sponsors
Principia Biopharma, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: half-life | From Day 11 to Day 12 | terminal elimination phase half-life |
| Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: Cmax | From Day 1 to Day 7 | maximun plasma concentration |
| Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: Tmax | From Day 1 to Day 7 | time to maximum plasma concentration |
| Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: AUC0-last | From Day 1 to Day 7 | area under the plasma concentration-time curve from zero to the last measurable concentration |
| Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: AUC0-inf | From Day 1 to Day 7 | area under the plasma concentration-time curve from zero to infinity |
| Rilzabrutinib plasma PK parameters following administration of the reference formulation in the fed and fasted states: half-life | From Day 1 to Day 7 | terminal elimination phase half-life |
| Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: Cmax | From Day 11 to Day 12 | maximun plasma concentration |
| Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: Tmax | From Day 11 to Day 12 | time to maximum plasma concentration |
| Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: AUC0-last | From Day 11 to Day 12 | area under the plasma concentration-time curve from zero to the last measurable concentration |
| Rilzabrutinib plasma PK parameters following administration of two test formulations in the fasted state: AUC0-inf | From Day 11 to Day 12 | area under the plasma concentration-time curve from zero to infinity |
Secondary
| Measure | Time frame |
|---|---|
| Treatment-emergent AE and treatment-emergent SAE | Until Day 15 |
Countries
Australia
Outcome results
None listed