A Study in Healthy Male Subjects to Understand How Savolitinib Behaves Inside the Body (Pharmacokinetics) When Administered Alone and in Combination With Famotidine

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
AstraZeneca
Study ID
NCT04179071
Phase
PHASE1
Status
Completed

Conditions

  • Solid Tumours

Eligibility Criteria

Sex
MALE
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Savolitinib — DRUG
    Subject will receive savolitinib tablet 600mg orally after a high-fat, high-calorie meal.
  • Famotidine — DRUG
    Subjects will receive famotidine tablet 40mg orally after an overnight (minimum 8hours) of fasting.

Study Details

This will be an open-label, randomised, 2 part (Part A and Part B), 2 treatment (savolitinib alone or in combination with famotidine), crossover study in healthy, non Japanese, male subjects, performed at a single study centre.

Key Dates

Start date
Dec 13, 2019
Status verified
Jun 2020
Primary completion
Mar 11, 2020
Completion
Mar 11, 2020

Study Design

Enrollment
16 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Savolitinib
    Subjects will receive single dose of 600mg savolitinib after a high-fat, high-calorie meal.
  • Experimental: Savolitinib + Famotidine
    Subjects will receive savolitinib 600mg single dose after high-fat, high-calorie meal and after 1.5 hours (Part A) or 5.5 hours (Part B) of famotidine 40mg dose. Famotidine will be administered after an overnight fast of at least 8 hours with approximately 240 mL of water.

Primary Outcome Measure

Maximum observed plasma concentration (Cmax) ratio [ Time Frame: At pre-dose, and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36, and 48 hours post-dose on Day 1-3 and Day 16-18 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Research SiteBaltimoreMaryland21225-

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Research Site· Baltimore, MD

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