A Study in Healthy Male Subjects to Understand How Savolitinib When Taken With Midazolam Behaves Inside the Body

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
AstraZeneca
Study ID
NCT04187456
Phase
PHASE1
Status
Completed

Conditions

  • Solid Tumors

Eligibility Criteria

Sex
MALE
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Savolitinib — DRUG
    Single dose (together with midazolam) on Study Day 5 after a high fat, high calorie breakfast.
  • Midazolam — DRUG
    Single dose (alone) on Study Day 1 and single dose (together with savolitinib) on Study Day 5, both after a high fat, high calorie breakfast.

Study Details

This study will be an open label, 2 period, fixed sequence study in healthy male subjects, performed at a single study center in the Unites States of America. The purpose of this study is to evaluate the effect of savolitinib on the PK of midazolam, a known cytochrome P450 (CYP) 3A substrate.

Key Dates

Start date
Dec 27, 2019
Status verified
Aug 2020
Primary completion
Mar 6, 2020
Completion
Mar 6, 2020

Study Design

Enrollment
14 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Midazolam + Savolitinib
    * Treatment Period 1: Single administration of midazolam (1 mg) will occur on Study Day 1, after a high fat, high calorie breakfast, followed by PK sampling for 24 hours. * Treatment Period 2: Single administration of midazolam 1 mg in combination with a single administration of savolitinib (600 mg), after a high fat, high calorie breakfast will occur on Study Day 5 and PK sampling will occur for 24 hours.

Primary Outcome Measure

Midazolam: Area under the plasma concentration-time curve from time zero to infinity (AUC) ratio of geometric means of test treatment (midazolam + savolitinib), relative to reference treatment (midazolam alone). [ Time Frame: Treatment period 1 and 2 (Study Days 1,2, 5 and 6). Midazolam- pre dose, and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 16 and 24 hours post dose on Study Days 1 and 5. Savolitinib- pre-dose and 1,2, 4, 6, 8, 12 and 24 hours post dose. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Research SiteBaltimoreMaryland21225-

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Research Site· Baltimore, MD

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