Healthy ParticipantsPhase 1NCT05512806
A Bioavailability and Food Effect Study of AZD5462 in Healthy Volunteers
A Phase 1 study testing AZD5462 in people with Healthy Participants, run by AstraZeneca at 1 site in United States.
Trial summary
This study will assess the pharmacokinetics of AZD5462 film-coated tablet formulation in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- AZD5462
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2022to 7 Nov 2022
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Healthy male and female participants aged 18 to 55 years at screening and admission with suitable veins for cannulation or repeated venipuncture.
- Females must have a negative pregnancy test at screening and on admission to the study center, must not be lactating and must be of non-childbearing potential confirmed at screening by fulfilling one of the following criteria:
- Postmenopausal defined as amenorrhea for at least 12 months or more following cessation of all exogenous hormonal treatments and Follicle-stimulating hormone (FSH)/Luteinizing hormone (LH) levels in the postmenopausal range.
- Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
- Male participant must adhere to the contraception methods details.
- Have a Body mass index (BMI) between 18 and 32 kg/m2 inclusive and weigh at least 50 kg and no more than 105 kg inclusive at screening.
Who cannot join
- History of any clinically significant disease or disorder which may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
- Any of the below conditions:
- Systemic sclerosis.
- Moderate to severe valvular disease.
- Hypertrophic obstructive cardiomyopathy.
- Restrictive cardiomyopathy.
Show all 47Show fewer
- Gilbert's syndrome.
- History of vascular or left ventricular aneurysms, or prior dissections.
- Any history of joint hypermobility, Marfan's Syndrome, or any connective tissue disorder.
- History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of Investigational medicinal product (IMP).
- Any laboratory values with the following deviations at screening, or admission to the study center:
- Total bilirubin > Upper limit of normal (ULN).
- Alanine aminotransferase > 1.5 × ULN.
- Aspartate aminotransferase > 1.5 × ULN.
- Estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73m2, as assessed by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
- White blood cell count < 3.5 k/uL and > ULN.
- Hemoglobin < Lower limit of normal (LLN).
- Any clinically significant abnormalities in clinical biochemistry, hematology, or urinalysis results.
- Any clinically significant abnormal findings in vital signs after 5 minutes supine rest, at screening or admission defined as any of the following:
- Systolic Blood pressure (BP) < 90 mmHg or ≥ 140 mmHg.
- Diastolic BP < 50 mmHg or ≥ 90 mmHg.
- Heart rate < 50 bpm or > 90 bpm.
- Any clinically important abnormalities in rhythm, conduction or morphology of the resting 12-lead Electrocardiogram (ECG) at screening or admission.
- Prolonged QTcF > 450 ms.
- Shortened QTcF < 340 ms.
- Family history of long QT syndrome.
- PR(PQ) interval shortening < 120 ms (PR > 110 ms but < 120 ms is acceptable if there is no evidence of ventricular pre-excitation).
- PR(PQ) interval prolongation (> 240 ms) intermittent second (Wenckebach block while asleep is not exclusive) or third-degree AV block, or AV dissociation.
- Persistent or intermittent complete BBB. Participants with Intraventricular conduction delay (IVCD) with QRS < 120 ms are acceptable if there is no evidence of eg, ventricular hypertrophy, or pre-excitation.
- 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.
- Has received another new chemical entity within 30 days of the first administration of IMP in this study.
- Plasma donation within 1 month of screening or any blood donation/loss > 500 mL during the 3 months prior to screening.
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, or history of hypersensitivity to drugs with a similar chemical structure or class to AZD5462.
- Current smokers or those who have smoked or used nicotine products within the 3 months prior to screening.
- Positive screen for drugs of abuse, alcohol, or cotinine at screening or on each admission to the study center prior to the first administration of the IMP.
- 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 non-prescribed medication including antacids, analgesics, herbal remedies, megadose vitamins, and minerals during the 2 weeks or 5 half-lives of the medication, whichever is longer, prior to the first administration of IMP.
- Known or suspected history of alcohol or drug abuse or excessive intake of alcohol.
- Excessive intake of caffeine-containing drinks or food.
- Participants who have previously received AZD5462.
- Any ongoing or recent minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements.
- Participants who are vegans or have medical dietary restrictions.
- Participants who cannot communicate reliably with the Principal Investigator (PI).
- Vulnerable participants, eg, kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.
- Clinical signs and symptoms consistent with Coronavirus disease 2019 (COVID-19), or confirmed infection by appropriate laboratory test within the last 4 weeks prior to screening or on admission.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, 6-period, 6-treatment, Single-Dose, Crossover Study to Assess the Pharmacokinetics of AZD5462 Film-coated Tablet Formulation, to Assess the Relative Bioavailability of AZD5462 Film-coated Tablet Formulation vs Oral Solution, and to Assess the Influence of Food on the Pharmacokinetics of AZD5462 in Healthy Participants
This study will assess the pharmacokinetics of AZD5462 film-coated tablet formulation in healthy participants.
Read the detailed description
This study will consist of six treatment periods.
A total of 16 healthy male and female participants of non-childbearing potential will be randomized in this study to ensure at least 12 evaluable participants at the end of the last treatment period.
The study will comprise of a Screening Period, six Treatment Periods, and a follow-up phone call:
- A screening period of maximum 28 days.
- Six treatment periods during which participants will be residents at the study center from Day -1 until Day 17.
Each participant will receive 6 treatments.
The following treatments will be given:-
- Treatment A: Dose A of AZD5462 film-coated tablet in a fasted state.
- Treatment B: Dose A of AZD5462 film-coated tablet in a fed state.
- Treatment C: Dose B of AZD5462 film-coated tablet in a fasted state.
- Treatment D: Dose B of AZD5462 oral solution in a fasted state.
- Treatment E: Dose C of AZD5462 film-coated tablet in a fasted state.
- Treatment F: Dose C of AZD5462 film-coated tablet in a fed state.
- A follow-up phone call will take place on Day 21 (± 1 day) to record adverse events (AEs) and concomitant medication.
- Conditions
- Healthy Participants
- Being tested
- AZD5462
- Keywords
- Healthy participants, Food effect, Relative bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD5462Drug
Participants will receive AZD5462 orally.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Participants will receive Dose A orally as a film-coated tablet. Receives: Drug: AZD5462 |
| Treatment B | Experimental | Participants will receive Dose A orally as a film-coated tablet. Receives: Drug: AZD5462 |
| Treatment C | Experimental | Participants will receive Dose B orally as a film-coated tablet. Receives: Drug: AZD5462 |
| Treatment D | Experimental | Participants will receive Dose B orally as an oral solution. Receives: Drug: AZD5462 |
| Treatment E | Experimental | Participants will receive Dose C orally as a film-coated tablet. Receives: Drug: AZD5462 |
| Treatment F | Experimental | Participants will receive Dose C orally as a film-coated tablet. Receives: Drug: AZD5462 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under plasma concentration time curve from zero to infinity (AUCinf)
The AUCinf of a film-coated tablet of AZD5462 at 3 dose levels will be assessed.
Measured: Day 1 to Day 17
Area under the plasma concentration-curve from time zero to last quantifiable concentration (AUClast)
The AUClast of a film-coated tablet of AZD5462 at 3 dose levels will be assessed.
Measured: Day 1 to Day 17
Maximum observed plasma (peak) drug concentration [Cmax]
The Cmax of a film-coated tablet of AZD5462 at 3 dose levels will be assessed.
Measured: Day 1 to Day 17
Area under plasma concentration time curve from zero to infinity (AUCinf)
The effect of a high-fat, high-calorie meal in comparison to fasting conditions on the AUCinf of AZD5462 after a single oral dose at 2 dose levels will be assessed.
Measured: Day 1 to Day 17
Area under the plasma concentration-curve from time zero to last quantifiable concentration (AUClast)
The effect of a high-fat, high-calorie meal in comparison to fasting conditions on the AUClast of AZD5462 after a single oral dose at 2 dose levels will be assessed.
Measured: Day 1 to Day 17
Maximum observed plasma (peak) drug concentration [Cmax]
The effect of a high-fat, high-calorie meal in comparison to fasting conditions on the Cmax of AZD5462 after a single oral dose at 2 dose levels will be assessed.
Measured: Day 1 to Day 17
Area under plasma concentration time curve from zero to infinity (AUCinf)
The relative bioavailability of the film-coated tablet vs oral solution formulation will be determined by the assessment of AUCinf.
Measured: Day 1 to Day 17
Area under the plasma concentration-curve from time zero to last quantifiable concentration (AUClast)
The relative bioavailability of the film-coated tablet vs oral solution formulation will be determined by the assessment of AUClast.
Measured: Day 1 to Day 17
Maximum observed plasma (peak) drug concentration [Cmax]
The relative bioavailability of the film-coated tablet vs oral solution formulation will be determined by the assessment of Cmax.
Measured: Day 1 to Day 17
Secondary outcomes (1)
Number of participants with Adverse Events (AEs), and Serious Adverse Events (SAEs)
The safety, and tolerability of single doses of AZD5462 in healthy participants will be assessed.
Measured: Until follow-up (Day 21)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start24 Aug 2022
- Primary completion7 Nov 2022
- Study completion7 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05512806
- Sponsor's protocol ID
- D9090C00005
- Status last verified
- Oct 2023
- First submitted
- 22 Aug 2022
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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 requests 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, 6-period, 6-treatment, Single-Dose, Crossover Study to Assess the Pharmacokinetics of AZD5462 Film-coated Tablet Formulation, to Assess the Relative Bioavailability of AZD5462 Film-coated Tablet Formulation vs Oral Solution, and to Assess the Influence of Food on the Pharmacokinetics of AZD5462 in Healthy Participants
- ClinicalTrials.gov ID
- NCT05512806
- Acronym / sponsor ID
- D9090C00005
- Conditions
- Healthy Participants
- Keywords
- Healthy participants, Food effect, Relative bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 24 Aug 2022 (actual)
- Primary completion
- 7 Nov 2022 (actual)
- Study completion
- 7 Nov 2022 (actual)
- First posted
- 23 Aug 2022 (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.
This study will assess the pharmacokinetics of AZD5462 film-coated tablet formulation in healthy participants.
Detailed description
This study will consist of six treatment periods.
A total of 16 healthy male and female participants of non-childbearing potential will be randomized in this study to ensure at least 12 evaluable participants at the end of the last treatment period.
The study will comprise of a Screening Period, six Treatment Periods, and a follow-up phone call:
- A screening period of maximum 28 days.
- Six treatment periods during which participants will be residents at the study center from Day -1 until Day 17.
Each participant will receive 6 treatments.
The following treatments will be given:-
- Treatment A: Dose A of AZD5462 film-coated tablet in a fasted state.
- Treatment B: Dose A of AZD5462 film-coated tablet in a fed state.
- Treatment C: Dose B of AZD5462 film-coated tablet in a fasted state.
- Treatment D: Dose B of AZD5462 oral solution in a fasted state.
- Treatment E: Dose C of AZD5462 film-coated tablet in a fasted state.
- Treatment F: Dose C of AZD5462 film-coated tablet in a fed state.
- A follow-up phone call will take place on Day 21 (± 1 day) to record adverse events (AEs) and concomitant medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: AZD5462Participants will receive Dose A orally as a film-coated tablet. |
| Treatment B | Experimental | Drug: AZD5462Participants will receive Dose A orally as a film-coated tablet. |
| Treatment C | Experimental | Drug: AZD5462Participants will receive Dose B orally as a film-coated tablet. |
| Treatment D | Experimental | Drug: AZD5462Participants will receive Dose B orally as an oral solution. |
| Treatment E | Experimental | Drug: AZD5462Participants will receive Dose C orally as a film-coated tablet. |
| Treatment F | Experimental | Drug: AZD5462Participants will receive Dose C orally as a film-coated tablet. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Healthy male and female participants aged 18 to 55 years at screening and admission with suitable veins for cannulation or repeated venipuncture.
- Females must have a negative pregnancy test at screening and on admission to the study center, must not be lactating and must be of non-childbearing potential confirmed at screening by fulfilling one of the following criteria:
- Male participant must adhere to the contraception methods details.
- Have a Body mass index (BMI) between 18 and 32 kg/m2 inclusive and weigh at least 50 kg and no more than 105 kg inclusive at screening.
Key exclusion criteria (47 listed)
- History of any clinically significant disease or disorder which may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
- Any of the below conditions:
- History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of Investigational medicinal product (IMP).
- Any laboratory values with the following deviations at screening, or admission to the study center:
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 |
|---|---|---|
| AZD5462Participants will receive AZD5462 orally. | Drug | Treatment A, Treatment B, Treatment C, Treatment D, Treatment E, Treatment F |
Primary outcome
Area under plasma concentration time curve from zero to infinity (AUCinf)
Time frame: Day 1 to Day 17
The AUCinf of a film-coated tablet of AZD5462 at 3 dose levels will be assessed.
Area under the plasma concentration-curve from time zero to last quantifiable concentration (AUClast)
Time frame: Day 1 to Day 17
The AUClast of a film-coated tablet of AZD5462 at 3 dose levels will be assessed.
Maximum observed plasma (peak) drug concentration [Cmax]
Time frame: Day 1 to Day 17
The Cmax of a film-coated tablet of AZD5462 at 3 dose levels will be assessed.
Area under plasma concentration time curve from zero to infinity (AUCinf)
Time frame: Day 1 to Day 17
The effect of a high-fat, high-calorie meal in comparison to fasting conditions on the AUCinf of AZD5462 after a single oral dose at 2 dose levels will be assessed.
Area under the plasma concentration-curve from time zero to last quantifiable concentration (AUClast)
Time frame: Day 1 to Day 17
The effect of a high-fat, high-calorie meal in comparison to fasting conditions on the AUClast of AZD5462 after a single oral dose at 2 dose levels will be assessed.
Maximum observed plasma (peak) drug concentration [Cmax]
Time frame: Day 1 to Day 17
The effect of a high-fat, high-calorie meal in comparison to fasting conditions on the Cmax of AZD5462 after a single oral dose at 2 dose levels will be assessed.
Area under plasma concentration time curve from zero to infinity (AUCinf)
Time frame: Day 1 to Day 17
The relative bioavailability of the film-coated tablet vs oral solution formulation will be determined by the assessment of AUCinf.
Area under the plasma concentration-curve from time zero to last quantifiable concentration (AUClast)
Time frame: Day 1 to Day 17
The relative bioavailability of the film-coated tablet vs oral solution formulation will be determined by the assessment of AUClast.
Maximum observed plasma (peak) drug concentration [Cmax]
Time frame: Day 1 to Day 17
The relative bioavailability of the film-coated tablet vs oral solution formulation will be determined by the assessment of Cmax.
1 secondary outcome
Number of participants with Adverse Events (AEs), and Serious Adverse Events (SAEs)
Time frame: Until follow-up (Day 21)
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 9 Nov 2023.
- 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 requests 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD5462 in people with Healthy Participants, run by AstraZeneca at 1 site in United States.
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 7 inclusion and 47 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 9 Nov 2023. 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 States. 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?
Area under plasma concentration time curve from zero to infinity (AUCinf) (time frame: Day 1 to Day 17). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Nov 2023.