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An Open-label DDI Study to Investigate the Effect of Rilzabrutinib on P-gp, BCRP, OATP1B1 and OATP1B3 Inhibition

ConditionHealthy Volunteer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorSanofi

About this trial

The study is a single-center, Phase-1, open-label, one-sequence, two-treatment period, cross-over, DDI study designed to investigate the effects of rilzabrutinib on the PK of digoxin (as P-gp substrate) and of rosuvastatin (as substrate of BCRP, OATP1B1, and OATP1B3) in healthy male and female participants. For this study a cocktail of digoxin and rosuvastatin will be used.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Participant must be 18 to 55 years of age inclusive.

Body weight between 50.0 and 100.0 kg for males, 40.0 and 90.0 kg for females.

Contraceptive use by male and female participants should be consistent with local regulations

Disqualifiers

History of serious infections requiring intravenous therapy.

Frequent headaches, migraine, nausea or vomiting.

Blood donation within 1 month before inclusion.

History of drug hypersensitivity or allergic disease.

Trial design

Design model

Single group

Treatments tested in this trial

  • Rilzabrutinib

    Drug

    From Day 1 to Day 12 of Period 2

  • Rosuvastatin

    Drug

    Single dose on Day 1 of Period 1 and on Day 8 of Period 2

  • Digoxin

    Drug

    Single dose on Day 1 of Period 1 and on Day 8 of Period 2

Treatment groups

14 Participants
are divided into 1 treatment group
Group A: Treatment A then Treatment BExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

AUC for digoxin and rosuvastatin

area under curve

Time frame
Up to Day 13 in Period 2
2

AUClast for digoxin and rosuvastatin

area under the curve from time zero to the last measurable concentration

Time frame
Up to Day 13 in Period 2
3

Cmax for digoxin and rosuvastatin

maximum (peak) plasma concentration

Time frame
Up to Day 13 in Period 2

Secondary outcomes

1

tmax for digoxin and for rosuvastatin

time to reach maximum plasma concentration

Time frame
Up to Day 13 in Period 2
2

tmax for rilzabrutinib

time to reach maximum plasma concentration

Time frame
Up to Day 11 in Period 2
3

Cmax for rilzabrutinib

maximum (peak) plasma concentration

Time frame
Up to Day 11 in Period 2
4

AUC0-tau for rilzabrutinib

area under the plasma concentration-time curve from time 0 to tau

Time frame
Up to Day 11 in Period 2

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sanofi

Lead sponsor

Source ClinicalTrials.gov
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