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

Completed · Phase 1

Conditions studied: Solid Tumours

In brief

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 facts

Study ID

NCT04179071

Run by

AstraZeneca

People needed

16

Starts

2019-12-13

Expected to finish

2020-03-11

Last updated by the study team

2020-07-07

Who can join

Age: 18 and older, up to 65. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Provision of signed and dated written informed consent prior to any study specific procedures.
• Healthy, non-Japanese male subjects with suitable veins for cannulation or repeated venipuncture: male subjects aged 18 to 65 years (inclusive).
• Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive; and weigh at least 50 kg and no more than 100 kg inclusive.
• Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and total bilirubin (TBL) less than or equal to the upper limit of normal for the institution.
• Have a calculated creatinine clearance greater than 80 mL/min using the Cockcroft-Gault formula at screening.
• Provision of signed, written and dated informed consent for optional genetic/biomarker research. If a subject declines to participate in the genetic component of the study, there will be no penalty or loss of benefit to the subject. The subject will not be excluded from other aspects of the study described in this protocol.

You may not qualify if…

• Subject that has at least 1 parent or grandparent (maternal or paternal) of Japanese ethnicity.
• Subjects who screen positive for Helicobacter pylori bacteria.
• History of any clinically significant disease or disorder which, in the opinion of the Principal Investigator (PI), may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study.
• History or presence of gastrointestinal (GI), hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
• Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of either study drug (savolitinib or famotidine).
• Planned in-patient surgery, dental procedure, or hospitalisation during the study.
• Any clinically important abnormalities in clinical chemistry, haematology, or urinalysis results, as judged by the PI.
• Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.
• Abnormal vital signs, after 5 minutes supine rest, defined as any of the following:
• Systolic BP <90 mmHg or ≥140 mmHg
• Diastolic BP <50 mmHg or ≥90 mmHg
• Heart rate <45 or >85 beats per minute.
• Any clinically important abnormalities in rhythm, conduction or morphology of the 12 lead resting electrocardiogram (ECG) that may interfere with the interpretation of QTc interval changes. These include healthy subjects with any of the following:
• Abnormal ST-T-wave morphology, particularly in the protocol-defined primary lead (V2) or left ventricular hypertrophy.
• PR interval shortening <120 ms (PR >110 ms but <120 ms is acceptable if there is no evidence of ventricular pre-excitation).
• PR interval prolongation (>200 ms). Intermittent second (Type 1 second degree block [Wenckebach Phenomenon] while asleep is not exclusive]) or third degree atrioventricular (AV) block, or AV dissociation.
• Persistent or intermittent complete bundle branch block, incomplete bundle branch block, or intraventricular conduction delay with QRS >110 ms. Subjects with QRS >110 ms but <115 ms are acceptable if there is no evidence of eg, ventricular hypertrophy or pre-excitation.
• Mean resting prolonged QTcF >450 ms or shortened QTcF <340 ms obtained from 3 ECGs.
• A history of additional risk factors for torsades de pointes (TdP) (eg, heart failure, chronic hypokalaemia not correctable with supplements, congenital or familial long QT syndrome, or family history of unexplained sudden death under 40 years of age in first-degree relatives).
• Use of any medications known to prolong the QT/QTc interval and cause TdP.
• Use of any prescribed or non prescribed medication including antacids, analgesics (other than ibuprofen up to 72 hours before dosing day), herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to the first administration of either study drug or longer if the medication has a long half life.
• Known or suspected history of drug abuse, as judged by the PI.
• Current smokers or those who have smoked or used nicotine products within the previous 30 days.
• History of alcohol abuse or excessive intake of alcohol as judged by the PI.
• Excessive intake of caffeine-containing drinks or food (eg, coffee, tea, chocolate) as judged by the PI.

Where it is running

• Research Site — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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