CancerPhase 1NCT04675021

Absolute Bioavailability and ADME Study of Savolitinib in Healthy Male Subjects

A Phase 1 study testing AZD6094 (Savolitinib) film coated tablets 600 mg, [14C]-AZD6094 (Savolitinib) Solution for Infusion, 20 μg/mL (NMT 37.0 kBq/5 mL) and [14C] AZD6094 (Savolitinib) Oral Solution, 300 mg (NMT 4.1 MBq) in people with Cancer, run by AstraZeneca at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 30 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for: Cancer
What is being tested?: AZD6094 (Savolitinib) film coated tablets 600 mg, [14C]-AZD6094 (Savolitinib) Solution for Infusion, 20 μg/mL (NMT 37.0 kBq/5 mL) and [14C] AZD6094 (Savolitinib) Oral Solution, 300 mg (NMT 4.1 MBq)
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteUnited Kingdom
Study dates: 13 Nov 2020to 11 Jan 2021
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 65 years
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Provision of signed and dated, written informed consent prior to any study specific procedures.
Healthy male subjects aged 30 to 65 years at the time of signing informed consent with suitable veins for cannulation or repeated venepuncture.
Body mass index (BMI) of 18.0 to 32.0 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive, as measured at screening.
Must be willing and able to communicate and participate in the whole study
Must have regular bowel movements (i.e., average stool production of ≥1 and
≤3 stools per day).
Adequate coagulation parameters, defined as: International Normalisation Ratio (INR) <1.5 x ULN and activated partial thromboplastin time (aPTT) <1.5 x ULN.
Must agree to adhere to the contraception requirements defined in Section 9.4. Subjects aged under 45 years must have had a vasectomy. Subjects must be willing to agree to not father children for a further 6 months after the study follow-up visit.

Who cannot join

History of any clinically significant disease or disorder which, in the opinion of the investigator, 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 GI, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
Acute diarrhoea or constipation in the 7 days before administration of IMP in the study. If screening occurs >7 days before the first study day, this criterion will be determined on first study day.
Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP.
Any clinically significant abnormalities in clinical chemistry, haematology, or urinalysis results, as judged by the investigator. Subjects with Gilbert's Syndrome are not allowed.
Any clinically significant abnormal findings in vital signs, as judged by the investigator.

Show all 38Show fewer

Any clinically significant abnormalities on 12-lead ECG, as judged by the investigator. Mean resting corrected QT interval (QTcF) >450 msec on screening or pre-dose (Part 1 only) obtained from 3 ECGs or factors that may increase the risk of QTcF prolongation or any clinically important abnormalities in rhythm, conduction or morphology of resting electrocardiograms (ECGs), e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval >250 msec.
Any factors that may increase the risk of QTcF prolongation such as 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 or any concomitant medication known to prolong the QT interval and cause Torsade de Pointes.
Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.
Known or suspected history of drug abuse, as judged by the investigator.
Has received another new chemical entity (defined as a compound which has not been approved for marketing; including radiolabelled chemical entity) within 90 days or five elimination half-lives, whichever is longer, of the first dosing date in this study. The period of exclusion lasts for 90 days or five elimination halflives after the final dose or 1 month after the last visit, whichever is the longest. Note: subjects consented and screened, but not administered IMP in this study or a previous Phase I study, are not excluded
Plasma donation within 1 month of screening or any blood donation/loss more than 500 mL during the 3 months prior to screening.
History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to savolitinib. Hay fever is allowed unless it is active
Evidence of current SARS-CoV-2 infection.
History of any alcohol abuse in the past 2 years.
Regular alcohol consumption in males >21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type).
Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the 6 months prior to screening. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission.
Subjects with pregnant or lactating partners.
Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017 [9], shall participate in the study.
Subjects who have been administered IMP in an 14C ADME study in the last 12 months.
Subjects with a history of cholecystectomy or gall stones.
Positive screen for drugs of abuse or alcohol at screening or on each admission to the study centre.
Subjects with estimated glomerular filtration rate [eGFR] of <60 mL/min/1.73m2, as measured at screening, using the chronic kidney disease epidemiology collaboration (CKD-EPI) equation, or evidence of renal impairment in subjects with eGFR between 60 and 90 mL/min/1.73m2.
Subjects with a presence of any of the following at screening:
<LLN for haemoglobin value, WBC, neutrophil count, lymphocytes and platelet count
Total bilirubin, ALT/AST>ULN at screening.
Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks prior to the first administration of IMP.
Use of any prescribed or nonprescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, megadose vitamins (intake of 20 to 600 times the recommended daily dose) and minerals during the two weeks prior to the first administration of IMP or longer if the medication has a long half-life.
Excessive intake of caffeine-containing drinks or food (e.g., coffee, tea, chocolate) as judged by the investigator. Excessive intake of caffeine defined as the regular consumption of more than 600 mg of caffeine per day (e.g., >5 cups of coffee) or would likely be unable to refrain from the use of caffeine-containing beverages during confinement at the investigational site.
Involvement of any AstraZeneca, Quotient or study site employee or their close relatives.
Subjects who report to have previously received savolitinib.
Judgment by the investigator that the volunteer should not participate in the study if they have any ongoing or recent (i.e., during the screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements.
Subjects who cannot communicate reliably with the investigator.
Vulnerable subjects, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.
Non-leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection or previous bone marrow transplant.
History of latent or chronic infections (e.g., tuberculosis, recurrent sinusitis, genital herpes, recurrent urinary tract infections) or at risk of infection (surgery, trauma or significant infection within previous 90 days, history of skin abscesses within previous 90 days prior to first IMP dose).
Planned in-patient surgery, dental procedure or hospitalisation during the study.
Failure to satisfy the investigator of fitness to participate for any other reason.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Research Site
Ruddington, NG11 6JS

Other trials in United Kingdom

About this study

Official title: A Phase I Open-label Study to Assess the Absolute Bioavailability of Savolitinib and Absorption, Distribution, Metabolism, Excretion of [14C]Savolitinib in Healthy Male Subjects

The Sponsor is developing the test medicine, AZD6094 (Savolitinib) for the potential treatment of cancer. Cancer is a condition where cells in a specific part of the body grow and reproduce uncontrollably, causing a growth called a tumour. The test medicine works to inhibit a pathway within the body which promotes tumours to grow and spread. The study involves radiolabelling (labelling the molecule with radioactive 14C) which is used to locate the molecule within the body.

The study will evaluate the absolute bioavailability of the test medicine (amount of the oral test medicine that enters the blood stream relative to the dose given into the vein), along with the mass balance (how much radioactivity can be recovered from the urine and faeces) and the rates and routes of elimination of [14C]savolitinib. It will also look to identify the breakdown products (metabolites) of the test medicine. The safety and tolerability of the test medicine will be assessed.

The study will consist of two parts, involving a minimum of eight healthy male volunteers. In Part one, following a high fat breakfast, volunteers will receive a single oral dose of the test medicine, followed by an intravenous infusion (solution into the vein) of radiolabelled test medicine. Volunteers will remain resident in the clinical unit until 72 hours post-oral dose.

There will then be a washout period of at least 14 days, after which the volunteers will return to the clinical unit for Part two. Volunteers will receive a single oral dose of radiolabelled test medicine as an oral solution. Blood, urine and faecal samples will be collected from volunteers whilst they are resident in the clinical unit for up to 168 hours postdose (Day 8). Volunteers will return for a follow-up visit at least 14 days after their last dose for safety assessments.

Conditions: Cancer
Being tested: AZD6094 (Savolitinib) film coated tablets 600 mg, [14C]-AZD6094 (Savolitinib) Solution for Infusion, 20 μg/mL (NMT 37.0 kBq/5 mL), [14C] AZD6094 (Savolitinib) Oral Solution, 300 mg (NMT 4.1 MBq)
Keywords: Cancer
Medical subject headings: Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AZD6094 (Savolitinib) film coated tablets 600 mgDrug
Also called AZD6094 (Savolitinib) Film Coated Tablet 200 mg x 3
AZD6094 (Savolitinib) ilm Coated Tablet 200 mg x 3
[14C]-AZD6094 (Savolitinib) Solution for Infusion, 20 μg/mL (NMT 37.0 kBq/5 mL)Drug
Also called 14C AZD6094 (Savolitinib) Solution for Infusion (20 μg/mL (NMT 37.0 kBq/5 mL)
14C AZD6094 (Savolitinib) Solution for Infusion (20 μg/mL (NMT 37.0 kBq/5 mL)
[14C] AZD6094 (Savolitinib) Oral Solution, 300 mg (NMT 4.1 MBq)Drug
Also called 14CAZD6094 (Savolitinib) Oral Solution (300 mg NMT 4.1MBq)
14CAZD6094 (Savolitinib) Oral Solution (300 mg NMT 4.1MBq)

Study groups in NCT04675021
Study group	Role	What they receive
AZD6094 (Savolitinib) D5084C00010	Experimental	All volunteers will receive either a single dose or two doses of AZD6094 (Savolitinib) D5084C00010 Receives: Drug: AZD6094 (Savolitinib) film coated tablets 600 mg; Drug: [14C]-AZD6094 (Savolitinib) Solution for Infusion, 20 μg/mL (NMT 37.0 kBq/5 mL); Drug: [14C] AZD6094 (Savolitinib) Oral Solution, 300 mg (NMT 4.1 MBq)

What is being measured

The primary outcome is the main question the study is designed to answer.

Absolute Bioavailability (F) of savolitinib
Absolute bioavailability based on AUC0-inf of oral formulation compared to IV adjusted for dose
Measured: Collection of plasma samples from pre-dose to 72 hours post-dose
The cumulative amount of AZD6094 (savolitinib) excreted (CumAe)
Assessment of the total radioactivity by measuring the cumulative amount of AZD6094 (savolitinib) excreted (CumAe)
Measured: Urine and faecal samples collected from pre-dose until 168 hours post-dose
The cumulative amount of AZD6094 (savolitinib) excreted and expressed as a percentage of the administered dose (CumFe)
Assessment of the total radioactivity by measuring the cumulative amount of AZD6094 (savolitinib) excreted and expressed as a percentage of the administered dose (CumFe)
Measured: Urine and faecal samples collected from pre-dose until 168 hours post-dose
Assessment of metabolites in plasma by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Assessment of metabolites in plasma by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Measured: Plasma samples collected until 168 hours post-dose
Assessment of metabolites in urine by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Assessment of metabolites in urine by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Measured: Urine samples collected until 168 hours post-dose
Assessment of metabolites in faeces by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Assessment of metabolites in faeces by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Measured: Faeces samples collected until 168 hours post-dose

Secondary outcomes (11)

Number of AE's experienced by subjects
Safety and tolerability assessed through the incidence of AEs
Measured: AEs recorded from the time of informed consent until the follow up visit (approx 10 weeks)
Time to maximum concentration (tmax) for AZD6094 (savolitinib) and total radioactivity
Assessment of pharmacokinetics of AZD6094 (savolitinib) and total radioactivity by measuring the time to maximum concentration (tmax)
Measured: Collection of plasma samples from pre-dose to 168 hours post-dose
Maximum observed concentration for AZD6094 and total radioactivity
Assessment of pharmacokinetics of AZD6094 and total radioactivity by measuring the maximum observed concentration (cmax)
Measured: Collection of plasma samples from pre-dose to 168 hours post-dose
Area under the curve from time 0 to the time of last measurable concentration for AZD6094 (savolitinib) and total radioactivity
Assessment of pharmacokinetics of AZD6094 (savolitinib) and total radioactivity by measuring the area under the curve from time 0 to the time of last measurable concentration
Measured: Collection of plasma samples from pre-dose to 168 hours post-dose
Area under the curve from time 0 extrapolated to infinity for AZD6094 (savolitinib) and total radtioactivity
Assessment of pharmacokinetics of AZD6094 (savolitinib) and total radioactivity by measuring the area under the curve from time 0 extrapolated to infinity
Measured: Collection of plasma samples from pre-dose to 168 hours post-dose
Terminal elimination half-life for AZD6094 (savolitinib) and total radioactivity
Assessment of pharmacokinetics of AZD6094 (savolitinib) and total radioactivity by measuring the terminal elimination half-life
Measured: Collection of plasma samples from pre-dose to 168 hours post-dose
First order rate constant associated with the terminal (log-linear) portion of the curve for AZD6094 (savolitinib) and total radioactivity
Assessment of pharmacokinetics of AZD6049 (savolitinib) and total radioactivity by measuring the First order rate constant associated with the terminal (log-linear) portion of the curve
Measured: Collection of plasma samples from pre-dose to 168 hours post-dose
Total body clearance calculated after a single extravascular administration for AZD6094 (savolitinib) and total radioactivity
Assessment of pharmacokinetics of AZD6049 (savolitinib) and total radioactivity by measuring the total body clearance calculated after a single extravascular administration
Measured: Collection of plasma samples from pre-dose to 168 hours post-dose
Apparent volume of distribution based on the terminal phase for AZD6094 (savolitinib) and total radioactivity
Assessment of pharmacokinetics of AZD6049 (savolitinib) and total radioactivity by measuring the apparent volume of distribution based on the terminal phase
Measured: Collection of plasma samples from pre-dose to 168 hours post-dose
Renal clearance for AZD6094 (savolitinib) and total radioactivity
Assessment of pharmacokinetics of AZD6049 (savolitinib) and total radioactivity by measuring the renal clearance
Measured: Collection of plasma samples from pre-dose to 168 hours post-dose
Evaluation of whole blood to plasma concentration ratios for total radioactivity
Assessment of total radioactivity in whole blood and plasma
Measured: Collection of blood samples until 168 hours post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Nov 202011 Jan 2021

First posted19 Dec 2020
Study start13 Nov 2020
Primary completion11 Jan 2021
Study completion11 Jan 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for CancerStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04675021
Sponsor's protocol ID: D5084C00010
Status last verified: Jan 2021
First submitted: 12 Nov 2020
Last updated: 26 Jan 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Publications

Miah K, Vishwanathan K, Scarfe G, Li Y, Hara I, Cantarini M, Argue J, Menakuru SR. A Phase 1 Study to Evaluate Absolute Bioavailability and Absorption, Distribution, Metabolism, and Excretion of Savolitinib in Healthy Male Volunteers. Clin Pharmacol Drug Dev. 2023 Apr;12(4):424-435. doi: 10.1002/cpdd.1224. Epub 2023 Feb 19.
PubMed 36808891

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Open-label Study to Assess the Absolute Bioavailability of Savolitinib and Absorption, Distribution, Metabolism, Excretion of [14C]Savolitinib in Healthy Male Subjects
ClinicalTrials.gov ID: NCT04675021
Acronym / sponsor ID: D5084C00010
Conditions: Cancer
Keywords: Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Quotient Sciences
Study start: 13 Nov 2020 (actual)
Primary completion: 11 Jan 2021 (actual)
Study completion: 11 Jan 2021 (actual)
First posted: 19 Dec 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
AZD6094 (Savolitinib) D5084C00010	Experimental	Drug: AZD6094 (Savolitinib) film coated tablets 600 mg, Drug: [14C]-AZD6094 (Savolitinib) Solution for Infusion, 20 μg/mL (NMT 37.0 kBq/5 mL), Drug: [14C] AZD6094 (Savolitinib) Oral Solution, 300 mg (NMT 4.1 MBq)All volunteers will receive either a single dose or two doses of AZD6094 (Savolitinib) D5084C00010

Who may qualify

Ages: 30 to 65 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Provision of signed and dated, written informed consent prior to any study specific procedures.
Healthy male subjects aged 30 to 65 years at the time of signing informed consent with suitable veins for cannulation or repeated venepuncture.
Body mass index (BMI) of 18.0 to 32.0 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive, as measured at screening.
Must be willing and able to communicate and participate in the whole study
Must have regular bowel movements (i.e., average stool production of ≥1 and

Key exclusion criteria (38 listed)

History of any clinically significant disease or disorder which, in the opinion of the investigator, 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 GI, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
Acute diarrhoea or constipation in the 7 days before administration of IMP in the study. If screening occurs >7 days before the first study day, this criterion will be determined on first study day.
Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of IMP.
Any clinically significant abnormalities in clinical chemistry, haematology, or urinalysis results, as judged by the investigator. Subjects with Gilbert's Syndrome are not allowed.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AZD6094 (Savolitinib) film coated tablets 600 mgAlso: AZD6094 (Savolitinib) Film Coated Tablet 200 mg x 3AZD6094 (Savolitinib) ilm Coated Tablet 200 mg x 3	Drug	AZD6094 (Savolitinib) D5084C00010
[14C]-AZD6094 (Savolitinib) Solution for Infusion, 20 μg/mL (NMT 37.0 kBq/5 mL)Also: 14C AZD6094 (Savolitinib) Solution for Infusion (20 μg/mL (NMT 37.0 kBq/5 mL)14C AZD6094 (Savolitinib) Solution for Infusion (20 μg/mL (NMT 37.0 kBq/5 mL)	Drug	AZD6094 (Savolitinib) D5084C00010
[14C] AZD6094 (Savolitinib) Oral Solution, 300 mg (NMT 4.1 MBq)Also: 14CAZD6094 (Savolitinib) Oral Solution (300 mg NMT 4.1MBq)14CAZD6094 (Savolitinib) Oral Solution (300 mg NMT 4.1MBq)	Drug	AZD6094 (Savolitinib) D5084C00010

Primary outcome

Absolute Bioavailability (F) of savolitinib
Time frame: Collection of plasma samples from pre-dose to 72 hours post-dose
Absolute bioavailability based on AUC0-inf of oral formulation compared to IV adjusted for dose
The cumulative amount of AZD6094 (savolitinib) excreted (CumAe)
Time frame: Urine and faecal samples collected from pre-dose until 168 hours post-dose
Assessment of the total radioactivity by measuring the cumulative amount of AZD6094 (savolitinib) excreted (CumAe)
The cumulative amount of AZD6094 (savolitinib) excreted and expressed as a percentage of the administered dose (CumFe)
Time frame: Urine and faecal samples collected from pre-dose until 168 hours post-dose
Assessment of the total radioactivity by measuring the cumulative amount of AZD6094 (savolitinib) excreted and expressed as a percentage of the administered dose (CumFe)
Assessment of metabolites in plasma by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Time frame: Plasma samples collected until 168 hours post-dose
Assessment of metabolites in plasma by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Assessment of metabolites in urine by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Time frame: Urine samples collected until 168 hours post-dose
Assessment of metabolites in urine by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Assessment of metabolites in faeces by liquid chromatography-radiochemical-detection and subsequent mass spectrometry
Time frame: Faeces samples collected until 168 hours post-dose
Assessment of metabolites in faeces by liquid chromatography-radiochemical-detection and subsequent mass spectrometry

11 secondary outcomes

Number of AE's experienced by subjects
Time frame: AEs recorded from the time of informed consent until the follow up visit (approx 10 weeks)
Time to maximum concentration (tmax) for AZD6094 (savolitinib) and total radioactivity
Time frame: Collection of plasma samples from pre-dose to 168 hours post-dose
Maximum observed concentration for AZD6094 and total radioactivity
Time frame: Collection of plasma samples from pre-dose to 168 hours post-dose
Area under the curve from time 0 to the time of last measurable concentration for AZD6094 (savolitinib) and total radioactivity
Time frame: Collection of plasma samples from pre-dose to 168 hours post-dose
Area under the curve from time 0 extrapolated to infinity for AZD6094 (savolitinib) and total radtioactivity
Time frame: Collection of plasma samples from pre-dose to 168 hours post-dose
Terminal elimination half-life for AZD6094 (savolitinib) and total radioactivity
Time frame: Collection of plasma samples from pre-dose to 168 hours post-dose
First order rate constant associated with the terminal (log-linear) portion of the curve for AZD6094 (savolitinib) and total radioactivity
Time frame: Collection of plasma samples from pre-dose to 168 hours post-dose
Total body clearance calculated after a single extravascular administration for AZD6094 (savolitinib) and total radioactivity
Time frame: Collection of plasma samples from pre-dose to 168 hours post-dose
Apparent volume of distribution based on the terminal phase for AZD6094 (savolitinib) and total radioactivity
Time frame: Collection of plasma samples from pre-dose to 168 hours post-dose
Renal clearance for AZD6094 (savolitinib) and total radioactivity
Time frame: Collection of plasma samples from pre-dose to 168 hours post-dose
Evaluation of whole blood to plasma concentration ratios for total radioactivity
Time frame: Collection of blood samples until 168 hours post dose

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
Derived from this study: PubMed 36808891Miah K, Vishwanathan K, Scarfe G, Li Y, Hara I, Cantarini M, Argue J, Menakuru SR. A Phase 1 Study to Evaluate Absolute Bioavailability and Absorption, Distribution, Metabolism, and Excretion of Savolitinib in Healthy Male Volunteers. Clin Pharmacol Drug Dev. 2023 Apr;12(4):424-435. doi: 10.1002/cpdd.1224. Epub 2023 Feb 19.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Related trials for Cancer

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RecruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Somasekhara Menakuru, MBBS MS MRCS principal investigator

Quotient Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute Bioavailability (F) of savolitinib (time frame: Collection of plasma samples from pre-dose to 72 hours post-dose). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04675021, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021.