A Study to Assess the Effects of Savolitinib on the Pharmacokinetics of Digoxin, Rosuvastatin, Metformin, and Furosemide in Healthy Male Subjects

Conditions

• Healthy Male Subjects

Eligibility Criteria

Sex

MALE

Age

18 Years - 55 Years

Healthy Volunteers

Accepted

Interventions

• Savolitinib — DRUG
  The subjects will receive single dose of oral film-coated tablet of Savolitinib A dose on Day 1 of Period 2 within 25 minutes \[+ 5 minutes\] from the start of meal.
• Digoxin — DRUG
  The subjects will receive single dose of oral uncoated tablet of Digoxin Dose B on Day 1 of Period 1 and Period 2 within 25 minutes \[+ 5 minutes\] from the start of meal.
• Metformin Hydrochloride — DRUG
  The subjects will receive single dose of oral film-coated tablet of Metformin Hydrochloride Dose D on Day 1 of Period 1 and Period 2 within 25 minutes \[+ 5 minutes\] from the start of meal.
• Rosuvastatin — DRUG
  The subjects will receive single dose of oral film-coated tablet of Rosuvastatin Dose E on Day 1 of Period 1 and Period 2 within 25 minutes \[+ 5 minutes\] from the start of meal.
• Furosemide — DRUG
  The subjects will receive single dose of oral solution of Furosemide Dose C on Day 1 of Period 1 and Period 2 within 25 minutes \[+ 5 minutes\] from the start of meal.

Study Details

This study will assess the effects of savolitinib on the pharmacokinetics (PK) of substrates of human transporters digoxin (P-gp), rosuvastatin (OATP1B1/3), metformin (OCT2, MATE1/2K), and furosemide (OAT1/3) in healthy male subjects, performed at a single clinical unit.

Key Dates

Start date

Apr 25, 2023

Status verified

Jul 2023

Primary completion

Jun 24, 2023

Completion

Jun 24, 2023

Study Design

Enrollment

6 participants (actual)

Allocation

NA

Intervention model

SEQUENTIAL

Primary purpose

OTHER

Arms

• Experimental: Drug cocktail/Savolitinib + Drug cocktail
  Subjects will receive two different interventions in two periods (Periods 1 and 2). In Period 1, the subjects will receive a single-dose of Drug cocktail components (digoxin Dose B, furosemide Dose C, metformin hydrochloride Dose D, and rosuvastatin Dose E). During Period 2, the subjects will receive savolitinib dose A in combination with the Drug cocktail components.

Primary Outcome Measure

Plasma Area Under Concentration-time Curve from zero to infinity (AUCinf) of the drug cocktail components [ Time Frame: Day 1 to Day 5 in Periods 1 (Week 1) and 2 (Week 4) ]