A Study to Evaluate the Amount of Drug That Becomes Available in the Blood Circulation When Savolitinib is Administered Alone and in Combination With Itraconazole

Conditions

• Solid Tumour

Eligibility Criteria

Sex

MALE

Age

18 Years - 65 Years

Healthy Volunteers

Accepted

Interventions

• Savolitinib — DRUG
  On Study Day 1 and Study Day 18, savolitinib will be administered as single dose after a high-fat, high-calorie breakfast
• Itraconazole — DRUG
  Twice daily on first day of dosing (Study Day 15) followed by once daily for 4 days (Study Day 16 - Study Day 19) administered 1 hour before any breakfast (and 1 hour before dinner on Study Day 15)

Study Details

This study will be conducted to quantify the magnitude of the effect of itraconazole co-administration on the PK of savolitinib. The exposure to savolitinib is predicted to increase when co-administered with the potent cytochrome P (CYP) 3A4 inhibitor itraconazole since CYP3A4 (via CYP450) is involved in the metabolism and elimination of savolitinib.

Key Dates

Start date

Nov 7, 2019

Status verified

Jan 2020

Primary completion

Jan 12, 2020

Completion

Jan 12, 2020

Study Design

Enrollment

16 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Savolitinib and/or Itraconazole
  Treatment Period 1: Single administration of savolitinib (200 mg) will occur on Study Day 1 after a high-fat, high-calorie breakfast followed by PK sampling for 48 hours Treatment Period 2: Itraconazole will be administered (200 mg BID) on Study Day 15, and (200 mg QD) on Study Days 16 and 17, 1 hour before breakfast (and before dinner, when applicable) Treatment Period 3: A single combination of itraconazole (200 mg) 1 hour before breakfast + savolitinib (200 mg) after a high-fat, high-calorie breakfast on Study Day 18, and a single dose of itraconazole (200 mg) on Study Day 19, 1 hour before breakfast

Primary Outcome Measure

Savolitinib area under plasma concentration-time curve from time zero to infinity (AUC) ratios of geometric means of test treatment (savolitinib+itraconazole), relative to reference treatment (savolitinib alone) [ Time Frame: Savolitinib,M2andM3:Treatment Periods1and3 (Study Days 1 and 18)pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 18, 24, 36 and 48 hours post-dose. Itraconazole:Treatment Period 3 (Study day 18)pre-dose, and 1 and 2 hours post-dose. ]

Locations (1)

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