A Study to Assess the Effects of Fluvoxamine on Savolitinib Exposure in Healthy Male Subjects

Conditions

• Healthy Male Subjects

Eligibility Criteria

Sex

MALE

Age

18 Years - 55 Years

Healthy Volunteers

Accepted

Interventions

• Savolitinib — DRUG
  Savolitinib will be administered as a single oral dose on Day 1 of Period 1 and on Day 5 of Period 2.
• Fluvoxamine — DRUG
  Only fluvoxamine will be administered as a twice daily oral dose from Days 1 to 4 of Period 2. On Day 5 of Period 2, subject will receive a twice daily oral dose of fluvoxamine along with savolitinib. On Day 6 of Period 2, subject will receive a twice daily oral dose of fluvoxamine alone.

Study Details

This study will assess the effects of strong CYP1A2 (Cytochrome P450 1A2) inhibitor (fluvoxamine) on savolitinib exposure in healthy male subjects, performed at a single clinical unit.

Key Dates

Start date

Jun 2, 2023

Status verified

Aug 2023

Primary completion

Aug 17, 2023

Completion

Aug 17, 2023

Study Design

Enrollment

16 participants (actual)

Allocation

NA

Intervention model

SEQUENTIAL

Primary purpose

OTHER

Arms

• Experimental: Savolitinib/Savolitinib+Fluvoxamine
  In period 1, subjects will receive a single oral dose of savolitinib on Day 1 after overnight fasting. Following minimum 10 days of washout after the last dose of savolitinib, in period 2 subjects will take oral doses of fluvoxamine alone, twice daily from Days 1 to 4. On Day 5 subject will receive a single oral dose of savolitinib and a twice daily oral dose of fluvoxamine. On Day 6, subjects will receive a twice daily oral dose of fluvoxamine alone.

Primary Outcome Measure

Maximum observed plasma (peak) drug concentration (Cmax) for savolitinib [ Time Frame: Period 1: Day 1 to Day 3 and Period 2: Day 5 to Day 7 ]

Locations (1)

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