Healthy VolunteersPhase 1NCT05630677
A Study to Compare Bioavailability of AZD5055 Film-coated Tablet With AZD5055 Oral Suspension and to Assess the Effect of Food and an Acid Reducing Agent on Pharmacokinetics (PK) of AZD5055 in Healthy Subjects.
A Phase 1 study testing AZD5055 solution for infusion, AZD5055 oral suspension and AZD5055 film-coated tablet in people with Healthy Volunteers, run by AstraZeneca at 1 site in United States.
Trial summary
This study will estimate the relative bioavailability of AZD5055 film-coated tablet as compared to AZD5055 oral suspension. The study will also assess the absolute bioavailabilty of AZD5055 and the effect of food and an acid reducing agent, rabeprazole, on the PK of AZD5055 film-coated tablets when given with food… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- AZD5055 solution for infusion, AZD5055 oral suspension and AZD5055 film-coated tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2022to 9 Feb 2023
- 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
- Healthy male and female (of non-childbearing potential) subjects aged 18 to 55 years.
- Female subjects must have a negative pregnancy test.
- Male subjects must adhere to the contraception methods as per Protocol.
- Have a BMI between 18 and 30 kg/m2 inclusive.
Who cannot join
- History of any clinically significant disease or disorder which may either put the subject at risk because of participation in the study or influence the results or the subject's ability to participate in the study.
- Ongoing acute Gastrointestinal (GI), hepatic, or renal disease, a history of chronic GI, hepatic, or renal disease, pancreatic disease, diabetes mellitus, or any 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 study drug.
- Ongoing acquired or inherited immunodeficiency disorders, including but not limited to Human Immunodeficiency Virus (HIV) or common variable immunodeficiency, or the subject is taking immune replacement therapy.
- Individuals with chronic infections or who are at increased risk of infection.
- History of cancer within the last 10 years (20 years for breast cancer). Any history of lymphoma is not allowed.
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- History of osteoporosis, osteomalacia, Paget's disease of the bone, thyrotoxicosis, rheumatoid arthritis, Cushing's disease, or a pathological fracture.
- History of a traumatic fracture within 6 months of the Screening Visit.
- Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis.
- Abnormal vital signs. Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG and any clinically important abnormalities in the 12-lead ECG.
- Untreated tuberculosis (TB) or a positive result for the Interferon gamma release assay (IGRA) (ie, QuantiFERON TB Gold).
- Any positive result at Screening for serum hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibody, and HIV antibody.
- History of severe COVID-19 infection requiring hospitalization within the last 12 months prior to Screening, or clinical history compatible with Long COVID-19 (symptoms beyond 12 weeks of acute infection).
- Confirmed COVID-19 infection during at admission.
- Has received live or live attenuated vaccine in the 30 days prior to dosing, the first dose of COVID- vaccine within 30 days prior to randomization, or a COVID-19 vaccine second or booster vaccination within 10 days of Screening.
- Known or suspected history of drug abuse.
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity.
- Current smokers or use of any tobacco in any other form.
- Known or suspected history of alcohol or drug abuse or excessive intake of alcohol.
- Use of drugs with enzyme-inducing properties such as St John's Wort.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Five-Period Study in Healthy Subjects to Investigate the Relative Bioavailability of AZD5055 Film-Coated Tablet Versus AZD5055 Oral Suspension Formulation, the Absolute Oral Bioavailability of AZD5055 and to Evaluate the Effect of Food and an Acid Reducing Agent on the Pharmacokinetics of AZD5055.
This study will estimate the relative bioavailability of AZD5055 film-coated tablet as compared to AZD5055 oral suspension. The study will also assess the absolute bioavailabilty of AZD5055 and the effect of food and an acid reducing agent, rabeprazole, on the PK of AZD5055 film-coated tablets when given with food (fed state) or without food (fasted state).
Read the detailed description
This will be an Open-Label, Five-Period Study in healthy subjects. The study will comprise of a Screening Period of maximum 28 days.
The treatment groups are as follows:
- Treatment A: AZD5055 solution for infusion as 20-minute infusion and an overnight fasted state after the 20-minute infusion.
- Treatment B: AZD5055 oral suspension and an overnight fasted state after the oral suspension.
- Treatment C: AZD5055 film-coated tablet and an overnight fasted state after the film-coated tablet..
- Treatment D: AZD5055 film-coated tablet, fed state (after a high-fat, high-calorie standard breakfast).
- Treatment E: Twice daily oral doses of 20 mg rabeprazole for 3 days prior a single dose of AZD5055 film-coated tablet under fasted conditions, and then rabeprazole will be continued for 2 days.
- Treatment F: Twice daily oral doses of 20 mg rabeprazole continuing from Treatment E prior to a single dose of AZD5055 film-coated tablet under fed conditions (low-fat standard breakfast) and then rabeprazole will be continued for 2 days.
Five (5) periods during which subjects will participate from Day -1 of Period 1 to 72 hours after the AZD5055 dose in Period 5.
- Period 1: On Day 1, the subjects will receive either Treatment A or Treatment B.
- Period 2: On Day 4, the subjects will receive Treatment C.
- Period 3: On Day 8, the subjects will receiveTreatment D.
- Period 4: On Day 10, three days prior to Day 1, rabeprazole will be administered twice daily. On Day 13, subject will receive Treatment E.
- Period 5: On Day 17, the subjects will receive Treatment F. Rabeprazole will continue twice daily, the last dose is on the evening of Study Day 18.
A Follow-up Visit, or telephone call, approximately 6 days after the last AZD5055 dose in Period 5.
There will be a minimum washout of 3 days between the AZD5055 dose administration in Period 1 and Period 2 and a minimum washout of 4 days between AZD5055 doses administrations for subsequent study periods.
Each subject will participate in the study for approximately 8 weeks.
- Conditions
- Healthy Volunteers
- Being tested
- AZD5055 solution for infusion, AZD5055 oral suspension, AZD5055 film-coated tablet, Rabeprazole, Delayed-release tablet
- Keywords
- Acid Reducing Agent, Bioavailability, Healthy subjects, pH-dependent solubility, Food Effect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD5055 solution for infusionDrug
Subjects will receive a single dose intravenous infusion of AZD5055 as 20-minute infusion on Day 1 of the respective period in overnight fasted state.
AZD5055 oral suspensionDrug
Subjects will receive single dose of AZD5055 oral suspension on Day 1 of the respective period in overnight fasted state.
AZD5055 film-coated tabletDrug
Subjects will receive single oral dose of AZD5055 film-coated tablets on Day 1 of the respective period in overnight fasted state.
AZD5055 film-coated tabletDrug
Subjects will receive single oral dose of AZD5055 film-coated tablets on Day 1 of the respective period in fed state (either a high fat meal or low-fat meal calorie standard breakfast)
Rabeprazole, Delayed-release tabletDrug
Subjects will receive oral doses of rabeprazole twice daily 3 days prior to AZD5055 single dose and 4 days after the AZD5055 single dose including the day that AZD5055 is dosed under fasted conditions [Study Day 10 to 18].
Rabeprazole, Delayed-release tabletDrug
Subjects will receive oral doses of rabeprazole twice daily prior to AZD5055 single dose under fed conditions (low-fat standard breakfast) and then continued for 2 days.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Subjects will receive AZD5055 solution as a 20-minute infusion in overnight fasted state on Day 1 in Period 1. Receives: Drug: AZD5055 solution for infusion |
| Treatment B | Experimental | Subjects will receive oral suspension of AZD5055 in an overnight fasted state on Day 1 in Period 1. Receives: Drug: AZD5055 oral suspension |
| Treatment C | Experimental | Subjects will receive AZD5055 film-coated tablet in overnight fasted state on Day 1 (Study Day 4) in Period 2. Receives: Drug: AZD5055 film-coated tablet |
| Treatment D | Experimental | Subjects will receive a standardized high-fat breakfast 30 minutes before film-coated tablet of AZD5055 administered as On Day 1 (Study Day 8) in Period 3. Receives: Drug: AZD5055 film-coated tablet |
| Treatment E | Experimental | Subjects will receive rabeprazole twice daily on Day 10. On Day 1 (Study Day 13), AZD5055 film-coated tablet will be administered, under fasted conditions, together with rabeprazole and rabeprazole dosing will continue twice daily in Period 4. Receives: Drug: AZD5055 film-coated tablet; Drug: Rabeprazole, Delayed-release tablet |
| Treatment F | Experimental | Subjects will receive a low-fat breakfast 30 minutes before AZD5055 film-coated tablet administered together with rabeprazole on Day 17. Rabeprazole will continue twice daily, the last dose is on the evening of Study Day 18 in Period 5. Receives: Drug: AZD5055 film-coated tablet; Drug: Rabeprazole, Delayed-release tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under concentration time curve from time 0 to infinity (AUCinf)
- To estimate the relative bioavailability of AZD5055 film-coated tablet formulation versus AZD5055 oral suspension formulation.
- To estimate the absolute bioavailability of AZD5055 oral suspension and AZD5055 film-coated tablet formulation.
- To assess the effect of the acid reducing agent, rabeprazole, on the PK of AZD5055 alone and in combination with acid reducing agent.
- To assess the effect of the acid reducing agent, rabeprazole, on the PK of AZD5055, when AZD5055 is administered.
Measured: Day 1-6, 8-10, 13-15, 17-19
Area under the concentration time curve from time 0 to the last quantifiable concentration (AUClast)
- To estimate the relative bioavailability of AZD5055 film-coated tablet formulation versus AZD5055 oral suspension formulation.
- To estimate the absolute bioavailability of AZD5055 oral suspension and AZD5055 film-coated tablet formulation.
- To assess the effect of food on the pharmacokinetic (PK) parameters of AZD5055 in the fed and fasted state.
- To assess the effect of the acid reducing agent, rabeprazole, on the PK of AZD5055 alone and in combination with acid reducing agent.
- To assess the effect of the acid reducing agent, rabeprazole, on the PK of AZD5055, when AZD5055 is administered in fasted and fed state.
Measured: Day 1-6, 8-10, 13-15, 17-19
Maximum observed concentration (Cmax)
- To estimate the relative bioavailability of AZD5055 film-coated tablet formulation versus AZD5055 oral suspension formulation.
- To estimate the absolute bioavailability of AZD5055 oral suspension and AZD5055 film-coated tablet formulation.
- To assess the effect of food on the pharmacokinetic (PK) parameters of AZD5055 in the fed and fasted state.
- To assess the effect of the acid reducing agent, rabeprazole, on the PK of AZD5055 alone and in combination with acid reducing agent.
- To assess the effect of the acid reducing agent, rabeprazole, on the PK of AZD5055, when AZD5055 is administered in fasted and fed state.
Measured: Day 1-6, 8-10, 13-15, 17-19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start4 Nov 2022
- Primary completion9 Feb 2023
- Study completion9 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
- Investigators
- Ronald Goldwater, MD, Principal investigator, PAREXEL Early Phase Clinical Unit Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05630677
- Sponsor's protocol ID
- D8960C00002
- Status last verified
- Mar 2024
- First submitted
- 4 Nov 2022
- Last updated
- 4 Mar 2024
- 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 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Five-Period Study in Healthy Subjects to Investigate the Relative Bioavailability of AZD5055 Film-Coated Tablet Versus AZD5055 Oral Suspension Formulation, the Absolute Oral Bioavailability of AZD5055 and to Evaluate the Effect of Food and an Acid Reducing Agent on the Pharmacokinetics of AZD5055.
- ClinicalTrials.gov ID
- NCT05630677
- Acronym / sponsor ID
- D8960C00002
- Conditions
- Healthy Volunteers
- Keywords
- Acid Reducing Agent, Bioavailability, Healthy subjects, pH-dependent solubility, Food Effect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 4 Nov 2022 (actual)
- Primary completion
- 9 Feb 2023 (actual)
- Study completion
- 9 Feb 2023 (actual)
- First posted
- 30 Nov 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 estimate the relative bioavailability of AZD5055 film-coated tablet as compared to AZD5055 oral suspension. The study will also assess the absolute bioavailabilty of AZD5055 and the effect of food and an acid reducing agent, rabeprazole, on the PK of AZD5055 film-coated tablets when given with food (fed state) or without food (fasted state).
Detailed description
This will be an Open-Label, Five-Period Study in healthy subjects. The study will comprise of a Screening Period of maximum 28 days.
The treatment groups are as follows:
- Treatment A: AZD5055 solution for infusion as 20-minute infusion and an overnight fasted state after the 20-minute infusion.
- Treatment B: AZD5055 oral suspension and an overnight fasted state after the oral suspension.
- Treatment C: AZD5055 film-coated tablet and an overnight fasted state after the film-coated tablet..
- Treatment D: AZD5055 film-coated tablet, fed state (after a high-fat, high-calorie standard breakfast).
- Treatment E: Twice daily oral doses of 20 mg rabeprazole for 3 days prior a single dose of AZD5055 film-coated tablet under fasted conditions, and then rabeprazole will be continued for 2 days.
- Treatment F: Twice daily oral doses of 20 mg rabeprazole continuing from Treatment E prior to a single dose of AZD5055 film-coated tablet under fed conditions (low-fat standard breakfast) and then rabeprazole will be continued for 2 days.
Five (5) periods during which subjects will participate from Day -1 of Period 1 to 72 hours after the AZD5055 dose in Period 5.
- Period 1: On Day 1, the subjects will receive either Treatment A or Treatment B.
- Period 2: On Day 4, the subjects will receive Treatment C.
- Period 3: On Day 8, the subjects will receiveTreatment D.
- Period 4: On Day 10, three days prior to Day 1, rabeprazole will be administered twice daily. On Day 13, subject will receive Treatment E.
- Period 5: On Day 17, the subjects will receive Treatment F. Rabeprazole will continue twice daily, the last dose is on the evening of Study Day 18.
A Follow-up Visit, or telephone call, approximately 6 days after the last AZD5055 dose in Period 5.
There will be a minimum washout of 3 days between the AZD5055 dose administration in Period 1 and Period 2 and a minimum washout of 4 days between AZD5055 doses administrations for subsequent study periods.
Each subject will participate in the study for approximately 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: AZD5055 solution for infusionSubjects will receive AZD5055 solution as a 20-minute infusion in overnight fasted state on Day 1 in Period 1. |
| Treatment B | Experimental | Drug: AZD5055 oral suspensionSubjects will receive oral suspension of AZD5055 in an overnight fasted state on Day 1 in Period 1. |
| Treatment C | Experimental | Drug: AZD5055 film-coated tabletSubjects will receive AZD5055 film-coated tablet in overnight fasted state on Day 1 (Study Day 4) in Period 2. |
| Treatment D | Experimental | Drug: AZD5055 film-coated tabletSubjects will receive a standardized high-fat breakfast 30 minutes before film-coated tablet of AZD5055 administered as On Day 1 (Study Day 8) in Period 3. |
| Treatment E | Experimental | Drug: AZD5055 film-coated tablet, Drug: Rabeprazole, Delayed-release tabletSubjects will receive rabeprazole twice daily on Day 10. On Day 1 (Study Day 13), AZD5055 film-coated tablet will be administered, under fasted conditions, together with rabeprazole and rabeprazole dosing will continue twice daily in Period 4. |
| Treatment F | Experimental | Drug: AZD5055 film-coated tablet, Drug: Rabeprazole, Delayed-release tabletSubjects will receive a low-fat breakfast 30 minutes before AZD5055 film-coated tablet administered together with rabeprazole on Day 17. Rabeprazole will continue twice daily, the last dose is on the evening of Study Day 18 in Period 5. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male and female (of non-childbearing potential) subjects aged 18 to 55 years.
- Female subjects must have a negative pregnancy test.
- Male subjects must adhere to the contraception methods as per Protocol.
- Have a BMI between 18 and 30 kg/m2 inclusive.
Key exclusion criteria (20 listed)
- History of any clinically significant disease or disorder which may either put the subject at risk because of participation in the study or influence the results or the subject's ability to participate in the study.
- Ongoing acute Gastrointestinal (GI), hepatic, or renal disease, a history of chronic GI, hepatic, or renal disease, pancreatic disease, diabetes mellitus, or any 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 study drug.
- Ongoing acquired or inherited immunodeficiency disorders, including but not limited to Human Immunodeficiency Virus (HIV) or common variable immunodeficiency, or the subject is taking immune replacement therapy.
- Individuals with chronic infections or who are at increased risk of infection.
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 |
|---|---|---|
| AZD5055 solution for infusionSubjects will receive a single dose intravenous infusion of AZD5055 as 20-minute infusion on Day 1 of the respective period in overnight fasted state. | Drug | Treatment A |
| AZD5055 oral suspensionSubjects will receive single dose of AZD5055 oral suspension on Day 1 of the respective period in overnight fasted state. | Drug | Treatment B |
| AZD5055 film-coated tabletSubjects will receive single oral dose of AZD5055 film-coated tablets on Day 1 of the respective period in overnight fasted state. | Drug | Treatment C, Treatment E |
| AZD5055 film-coated tabletSubjects will receive single oral dose of AZD5055 film-coated tablets on Day 1 of the respective period in fed state (either a high fat meal or low-fat meal calorie standard breakfast) | Drug | Treatment D, Treatment F |
| Rabeprazole, Delayed-release tabletSubjects will receive oral doses of rabeprazole twice daily 3 days prior to AZD5055 single dose and 4 days after the AZD5055 single dose including the day that AZD5055 is dosed under fasted conditions [Study Day 10 to 18]. | Drug | Treatment E |
| Rabeprazole, Delayed-release tabletSubjects will receive oral doses of rabeprazole twice daily prior to AZD5055 single dose under fed conditions (low-fat standard breakfast) and then continued for 2 days. | Drug | Treatment F |
Primary outcome
Area under concentration time curve from time 0 to infinity (AUCinf)
Time frame: Day 1-6, 8-10, 13-15, 17-19
* To estimate the relative bioavailability of AZD5055 film-coated tablet formulation versus AZD5055 oral suspension formulation. * To estimate the absolute bioavailability of AZD5055 oral suspension and AZD5055 film-coated tablet formulation. * To assess the effect of the acid reducing agent, rabeprazole, on the PK of AZD5055 alone and in combination with acid reducing agent. * To assess the effect of the acid reducing agent, rabeprazole, on the PK of AZD5055, when AZD5055 is administered.
Area under the concentration time curve from time 0 to the last quantifiable concentration (AUClast)
Time frame: Day 1-6, 8-10, 13-15, 17-19
* To estimate the relative bioavailability of AZD5055 film-coated tablet formulation versus AZD5055 oral suspension formulation. * To estimate the absolute bioavailability of AZD5055 oral suspension and AZD5055 film-coated tablet formulation. * To assess the effect of food on the pharmacokinetic (PK) parameters of AZD5055 in the fed and fasted state. * To assess the effect of the acid reducing agent, rabeprazole, on the PK of AZD5055 alone and in combination with acid reducing agent. * To assess the effect of the acid reducing agent, rabeprazole, on the PK of AZD5055, when AZD5055 is administered in fasted and fed state.
Maximum observed concentration (Cmax)
Time frame: Day 1-6, 8-10, 13-15, 17-19
* To estimate the relative bioavailability of AZD5055 film-coated tablet formulation versus AZD5055 oral suspension formulation. * To estimate the absolute bioavailability of AZD5055 oral suspension and AZD5055 film-coated tablet formulation. * To assess the effect of food on the pharmacokinetic (PK) parameters of AZD5055 in the fed and fasted state. * To assess the effect of the acid reducing agent, rabeprazole, on the PK of AZD5055 alone and in combination with acid reducing agent. * To assess the effect of the acid reducing agent, rabeprazole, on the PK of AZD5055, when AZD5055 is administered in fasted and fed state.
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 4 Mar 2024.
- D8960C00002\_CSR Synopsis\_Redacted.pdfLink provided by the sponsor.
- 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.
Ronald Goldwater, MD principal investigator
PAREXEL Early Phase Clinical Unit Baltimore
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 AZD5055 solution for infusion, AZD5055 oral suspension and AZD5055 film-coated tablet in people with Healthy Volunteers, 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 4 inclusion and 20 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 4 Mar 2024. 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 concentration time curve from time 0 to infinity (AUCinf) (time frame: Day 1-6, 8-10, 13-15, 17-19). The study lists 3 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 4 Mar 2024.