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

First listed

Mar 14, 2023

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) ]