Recruiting
Phase 1

Rilzabrutinib, Digoxin, Rosuvastatin

Sponsor:

Sanofi

Code:

NCT07855250

Conditions

Healthy Volunteer

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Rilzabrutinib

Rosuvastatin

Digoxin

Study Details

Brief summary:

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.

Conditions

Healthy Volunteer

Study ID

NCT07855250

Start date

Oct 1, 2026

Status verified date

Sep, 2026

Completion date

Nov 3, 2026

Anticipated

Primary completion date

Nov 3, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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.
  • History of drug or alcohol abuse.
  • Smoking regularly more than 5 cigarettes or equivalent in nicotine per week
  • Excessive consumption of beverages containing xanthine bases.
  • Pregnancy or breastfeeding.
  • Recent vaccinations.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Study Design

Enrollment

14 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Treatment A then Treatment B

Treatment A in Period 1: digoxin + rosuvastatin cocktail alone on Day 1 of Period 1 Treatment B in Period 2: rilzabrutinib (SAR444671) BID from Day 1 to Day 12 of Period 2, plus digoxin + rosuvastatin cocktail on Day 8 of Period 2

Interventions

Rilzabrutinib

From Day 1 to Day 12 of Period 2

Rosuvastatin

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

Digoxin

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

Primary outcome measure

  • AUC for digoxin and rosuvastatin [ Time Frame: Up to Day 13 in Period 2 ]
  • AUClast for digoxin and rosuvastatin [ Time Frame: Up to Day 13 in Period 2 ]
  • Cmax for digoxin and rosuvastatin [ Time Frame: Up to Day 13 in Period 2 ]

Central Contacts and Locations

Central contacts

Trial Transparency email recommended (Toll free for US & Canada)

800-633-1610Contact-US@sanofi.com

Locations

Investigational Site Number : 1240001

Recruiting

Québec, Quebec, Canada, G1P 0A2

More Information

Sponsor

Sanofi

Last update posted

Oct 2, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by Sanofi on 2026-10-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.