Healthy ParticipantsPhase 1NCT05511025
Assess the Safety, Tolerability, and Pharmacokinetics of AZD6234 Following Single Ascending Dose Administration to Healthy Subjects Who Are Overweight or Obese
A Phase 1 study testing AZD6234 and Acetaminophen in people with Healthy Participants, run by AstraZeneca at 2 sites in United States.
Trial summary
A study in healthy male and female participants of non-childbearing potential who are overweight or obese. 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?
- AZD6234 and Acetaminophen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Sep 2022to 19 Dec 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
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Healthy male and female participants aged 18 to 55 years with suitable veins for cannulation or repeated venipuncture.
- Females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit, must not be lactating and must be of non childbearing potential, confirmed at the Screening Visit by fulfilling one of the following criteria:
- Post menopausal defined as amenorrhea for at least 12 months or more following cessation of all exogenous hormonal treatments and Follicle stimulating hormone (FSH) levels in the post menopausal range.
- Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
- Have a body mass index (BMI) of 25 to 35 kg/m2 inclusive (at the time of screening) and weigh at least 50 kg.
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- For the Japanese cohort(s):
- Participant is a native of Japan; defined as having both parents and four grandparents who are Japanese. This includes second and third generation subjects of Japanese descent whose parents or grandparents are living in a country other than Japan.
- Have a BMI of 23 to 35 kg/m2 inclusive (at the time of screening) and weigh at least 50 kg.
Who cannot join
- History of any clinically important disease or disorder which, in the opinion of the Investigator, 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, including:
- Gastroparesis (or similar) requiring treatment, or (ii) Previous surgery of the upper gastrointestinal tract, or (iii) Cardiovascular disease, including but not limited to sick sinus syndrome, valvular disease, and cardiomyopathy, or (iv) Neuromuscular or neurogenic disease, or (v) Severe vitamin D deficiency < 12 ng/dL (as assessed by screening laboratory results or history), or (vi) Type 1 or type 2 diabetes mellitus.
- 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 important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP.
- Any laboratory values with the following deviations:
- Alanine aminotransferase > Upper limit of normal (ULN) (ii) Aspartate aminotransferase > ULN (iii) eGFR < 60 ml/min/1.73 m2 (calculated using the CKD EPI formula) (iv) White blood cell count < LLN (v) Hemoglobin < LLN (vi) Total calcium or corrected calcium/ionized calcium < LLN or > ULN
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- Abnormal vital signs, after 10 minutes supine rest, defined as any of the following:
- Systolic Blood pressure (BP) < 90 mmHg or > 140 mmHg. (ii) Diastolic BP < 50 mmHg or > 90 mmHg. (iii) Heart rate < 55 or > 85 beats per minute (bpm)
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to drugs with a similar chemical structure or class to AZD6234.
- Has received another new chemical entity (defined as a compound which has not been approved for marketing) within at least 30 days or 5 half-lives (whichever is longer) of the first administration of IMP in this study. The period of exclusion begins 30 days or 5 half-lives after the last visit in the previous study, whichever is the longest.
- Participants who are vegans or have medical dietary restrictions.
- Vulnerable participants, eg, kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Research Site
Brooklyn, Maryland, 21225
Research Site
Glendale, California, 91206
About this study
Official title: A Phase I Randomized Single-blind Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD6234 Following Single Ascending Dose Administration to Healthy Subjects Who Are Overweight or Obese
A study in healthy male and female participants of non-childbearing potential who are overweight or obese.
Read the detailed description
The study will comprise of:
- A Screening Period of maximum 28 days.
- A Treatment Period during which participants will be resident at the Clinical Unit from three days before (Day -3 ) Investigational Medicinal Product (IMP) administration (Day 1) until at least 4 days (96 hours) after IMP administration, participants will then be discharged on the morning of Day 5.
- Weekly outpatient visits on Days 8, 15, 22, 29, and 36 for blood sample collection, Electrocardiogram (ECGs), and adverse events (AE) recording.
- A Follow-up Visit 6 weeks (Day 43) after the last IMP dose.
Furthermore, 3 dose levels of AZD6234 for Subcutaneous (SC) administration (Cohorts 1 to 3) and one dose level for Intravenous (IV) administration (Cohort 4) are planned to be investigated in healthy participants who are overweight or obese. The IV cohort (Cohort 4) can begin in parallel or after Cohort 3. One dose level for SC administration is planned to be investigated in Japanese participants only (Cohort 5), and up to 3 additional dose levels for SC administration are planned to be investigated in healthy participants (Cohort 6 to 8). Depending on the findings, additional (optional) dose level cohorts may be added at the discretion of the Sponsor.
- Conditions
- Healthy Participants
- Being tested
- AZD6234, Placebo, Acetaminophen
- Keywords
- Overweight, Obese, Non-childbearing
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD6234Drug
Participants will receive a single dose of AZD6234 as a solution via SC or IV injection
PlaceboDrug
Participants will receive matching volumes of the placebo as a solution via SC or IV injection
AcetaminophenCombination product
Participants will receive a single dose of acetaminophen as part of a meal
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Participants will receive single ascending doses of AZD6234 via SC injection and matching volumes of the placebo as a solution via SC Receives: Drug: AZD6234; Drug: Placebo; Combination Product: Acetaminophen |
| Cohort 2 | Experimental | Participants will receive a single dose of AZD6234 via an SC injection and matching volume of the placebo as a solution via SC injection Receives: Drug: AZD6234; Drug: Placebo; Combination Product: Acetaminophen |
| Cohort 3 | Experimental | Participants will receive single ascending doses of AZD6234 via SC injection and matching volumes of the placebo as a solution via SC injection Receives: Drug: AZD6234; Drug: Placebo; Combination Product: Acetaminophen |
| Cohort 4 | Experimental | Participants will receive single ascending doses of AZD6234 via IV injection and matching volumes of the placebo as a solution via IV injection Receives: Drug: AZD6234; Drug: Placebo; Combination Product: Acetaminophen |
| Cohort 5 | Experimental | One dose level for SC administration is planned to be investigated for Japanese participants only Receives: Drug: AZD6234; Drug: Placebo; Combination Product: Acetaminophen |
| Cohort 6 | Experimental | Participants will receive single ascending doses of AZD6234 via SC injection and matching volumes of the placebo as a solution via SC injection Receives: Drug: AZD6234; Drug: Placebo; Combination Product: Acetaminophen |
| Cohort 7 | Experimental | Participants will receive single ascending doses of AZD6234 via SC injection and matching volumes of the placebo as a solution via SC injection Receives: Drug: AZD6234; Drug: Placebo; Combination Product: Acetaminophen |
| Cohort 8 | Experimental | Participants will receive AZD6234 via SC injection and matching volumes of placebo as a solution via SC injection Receives: Drug: AZD6234; Drug: Placebo; Combination Product: Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with AEs and Serious Adverse Events(SAE)
The safety and tolerability of AZD6234 following subcutaneous and/or intravenous administration of single ascending doses in healthy participants, including Japanese participants, who are overweight or obese will be assessed.
Measured: From Screening until Follow up (Day 43)
Secondary outcomes (16)
Maximum observed plasma drug concentration (Cmax)
The pharmacokinetics of AZD6234 in plasma following subcutaneous and/or intravenous administration of single ascending doses of AZD6234 in healthy participants, including Japanese participants, who are overweight or obese will be assessed.
Measured: From Day 1 until Follow up (Day 43)
Area under the plasma concentration-time (AUClast)
The pharmacokinetics of AZD6234 in plasma following subcutaneous and/or intravenous administration of single ascending doses of AZD6234 in healthy participants, including Japanese participants, who are overweight or obese will be assessed.
Measured: From Day 1 until Follow up (Day 43)
Area under plasma concentration-time curve from zero to infinity (AUCinf)
The pharmacokinetics of AZD6234 in plasma following subcutaneous and/or intravenous administration of single ascending doses of AZD6234 in healthy participants, including Japanese participants, who are overweight or obese will be assessed.
Measured: From Day 1 until Follow up (Day 43)
Time to reach maximum observed concentration (tmax)
The pharmacokinetics of AZD6234 in plasma following subcutaneous and/or intravenous administration of single ascending doses of AZD6234 in healthy participants, including Japanese participants, who are overweight or obese will be assessed.
Measured: From Day 1 until Follow up (Day 43)
Terminal rate constant (λz)
The pharmacokinetics of AZD6234 in plasma following subcutaneous and/or intravenous administration of single ascending doses of AZD6234 in healthy participants, including Japanese participants, who are overweight or obese will be assessed.
Measured: From Day 1 until Follow up (Day 43)
Terminal elimination half-life (t½λz)
The pharmacokinetics of AZD6234 in plasma following subcutaneous and/or intravenous administration of single ascending doses of AZD6234 in healthy participants, including Japanese participants, who are overweight or obese will be assessed.
Measured: From Day 1 until Follow up (Day 43)
Total body clearance of drug from plasma (IV dosing only) (CL)
The pharmacokinetics of AZD6234 in plasma following subcutaneous and/or intravenous administration of single ascending doses of AZD6234 in healthy participants, including Japanese participants, who are overweight or obese will be assessed.
Measured: From Day 1 until Follow up (Day 43)
Apparent total body clearance of drug from plasma (SC dosing only) (CL/F)
The pharmacokinetics of AZD6234 in plasma following subcutaneous and/or intravenous administration of single ascending doses of AZD6234 in healthy participants, including Japanese participants, who are overweight or obese will be assessed.
Measured: From Day 1 until Follow up (Day 43)
Volume of distribution based on the terminal phase (IV dosing only) (Vz)
The pharmacokinetics of AZD6234 in plasma following subcutaneous and/or intravenous administration of single ascending doses of AZD6234 in healthy participants, including Japanese participants, who are overweight or obese will be assessed.
Measured: From Day 1 until Follow up (Day 43)
Apparent volume of distribution based on the terminal phase (SC dosing only) (Vz/F)
The pharmacokinetics of AZD6234 in plasma following subcutaneous and/or intravenous administration of single ascending doses of AZD6234 in healthy participants, including Japanese participants, who are overweight or obese will be assessed.
Measured: From Day 1 until Follow up (Day 43)
Dose-normalized AUClast (AUClast/D)
The pharmacokinetics of AZD6234 in plasma following subcutaneous and/or intravenous administration of single ascending doses of AZD6234 in healthy participants, including Japanese participants, who are overweight or obese will be assessed.
Measured: From Day 1 until Follow up (Day 43)
Dose-normalized AUCinf (AUCinf/D)
The pharmacokinetics of AZD6234 in plasma following subcutaneous and/or intravenous administration of single ascending doses of AZD6234 in healthy participants, including Japanese participants, who are overweight or obese will be assessed.
Measured: From Day 1 until Follow up (Day 43)
Dose-normalized Cmax (Cmax/D)
The pharmacokinetics of AZD6234 in plasma following subcutaneous and/or intravenous administration of single ascending doses of AZD6234 in healthy participants, including Japanese participants, who are overweight or obese will be assessed.
Measured: From Day 1 until Follow up (Day 43)
Time of last observed (quantifiable) concentration (tlast)
The pharmacokinetics of AZD6234 in plasma following subcutaneous and/or intravenous administration of single ascending doses of AZD6234 in healthy participants, including Japanese participants, who are overweight or obese will be assessed.
Measured: From Day 1 until Follow up (Day 43)
Prevalence and incidence of anti-drug antibodies (ADAs) to AZD6234
The immunogenicity following subcutaneous and/or intravenous administration of single ascending doses of AZD6234 in healthy participants, including Japanese participants, who are overweight or obese will be assessed.
Measured: Day 1, Day 15, Day 29 and at Follow up (Day 43)
ADA titer
The immunogenicity following subcutaneous and/or intravenous administration of single ascending doses of AZD6234 in healthy subjects, including Japanese subjects, who are overweight or obese will be assessed
Measured: Day 1, Day 15, Day 29 and at Follow up (Day 43)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start20 Sep 2022
- Primary completion19 Dec 2023
- Study completion19 Dec 2023
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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511025
- Sponsor's protocol ID
- D8750C00001
- Status last verified
- Dec 2023
- First submitted
- 19 Aug 2022
- Last updated
- 26 Dec 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 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Randomized Single-blind Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD6234 Following Single Ascending Dose Administration to Healthy Subjects Who Are Overweight or Obese
- ClinicalTrials.gov ID
- NCT05511025
- Acronym / sponsor ID
- D8750C00001
- Conditions
- Healthy Participants
- Keywords
- Overweight, Obese, Non-childbearing
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 19 Dec 2023 (actual)
- Study completion
- 19 Dec 2023 (actual)
- First posted
- 22 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.
A study in healthy male and female participants of non-childbearing potential who are overweight or obese.
Detailed description
The study will comprise of:
- A Screening Period of maximum 28 days.
- A Treatment Period during which participants will be resident at the Clinical Unit from three days before (Day -3 ) Investigational Medicinal Product (IMP) administration (Day 1) until at least 4 days (96 hours) after IMP administration, participants will then be discharged on the morning of Day 5.
- Weekly outpatient visits on Days 8, 15, 22, 29, and 36 for blood sample collection, Electrocardiogram (ECGs), and adverse events (AE) recording.
- A Follow-up Visit 6 weeks (Day 43) after the last IMP dose.
Furthermore, 3 dose levels of AZD6234 for Subcutaneous (SC) administration (Cohorts 1 to 3) and one dose level for Intravenous (IV) administration (Cohort 4) are planned to be investigated in healthy participants who are overweight or obese. The IV cohort (Cohort 4) can begin in parallel or after Cohort 3. One dose level for SC administration is planned to be investigated in Japanese participants only (Cohort 5), and up to 3 additional dose levels for SC administration are planned to be investigated in healthy participants (Cohort 6 to 8). Depending on the findings, additional (optional) dose level cohorts may be added at the discretion of the Sponsor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: AZD6234, Drug: Placebo, Combination Product: AcetaminophenParticipants will receive single ascending doses of AZD6234 via SC injection and matching volumes of the placebo as a solution via SC |
| Cohort 2 | Experimental | Drug: AZD6234, Drug: Placebo, Combination Product: AcetaminophenParticipants will receive a single dose of AZD6234 via an SC injection and matching volume of the placebo as a solution via SC injection |
| Cohort 3 | Experimental | Drug: AZD6234, Drug: Placebo, Combination Product: AcetaminophenParticipants will receive single ascending doses of AZD6234 via SC injection and matching volumes of the placebo as a solution via SC injection |
| Cohort 4 | Experimental | Drug: AZD6234, Drug: Placebo, Combination Product: AcetaminophenParticipants will receive single ascending doses of AZD6234 via IV injection and matching volumes of the placebo as a solution via IV injection |
| Cohort 5 | Experimental | Drug: AZD6234, Drug: Placebo, Combination Product: AcetaminophenOne dose level for SC administration is planned to be investigated for Japanese participants only |
| Cohort 6 | Experimental | Drug: AZD6234, Drug: Placebo, Combination Product: AcetaminophenParticipants will receive single ascending doses of AZD6234 via SC injection and matching volumes of the placebo as a solution via SC injection |
| Cohort 7 | Experimental | Drug: AZD6234, Drug: Placebo, Combination Product: AcetaminophenParticipants will receive single ascending doses of AZD6234 via SC injection and matching volumes of the placebo as a solution via SC injection |
| Cohort 8 | Experimental | Drug: AZD6234, Drug: Placebo, Combination Product: AcetaminophenParticipants will receive AZD6234 via SC injection and matching volumes of placebo as a solution via SC injection |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 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 with suitable veins for cannulation or repeated venipuncture.
- Females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit, must not be lactating and must be of non childbearing potential, confirmed at the Screening Visit by fulfilling one of the following criteria:
- Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
- Have a body mass index (BMI) of 25 to 35 kg/m2 inclusive (at the time of screening) and weigh at least 50 kg.
Key exclusion criteria (12 listed)
- History of any clinically important disease or disorder which, in the opinion of the Investigator, 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, including:
- 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 important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP.
- Any laboratory values with the following deviations:
- Abnormal vital signs, after 10 minutes supine rest, defined as any of the following:
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 |
|---|---|---|
| AZD6234Participants will receive a single dose of AZD6234 as a solution via SC or IV injection | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7, Cohort 8 |
| PlaceboParticipants will receive matching volumes of the placebo as a solution via SC or IV injection | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7, Cohort 8 |
| AcetaminophenParticipants will receive a single dose of acetaminophen as part of a meal | Combination product | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7, Cohort 8 |
Primary outcome
Number of participants with AEs and Serious Adverse Events(SAE)
Time frame: From Screening until Follow up (Day 43)
The safety and tolerability of AZD6234 following subcutaneous and/or intravenous administration of single ascending doses in healthy participants, including Japanese participants, who are overweight or obese will be assessed.
16 secondary outcomes
Maximum observed plasma drug concentration (Cmax)
Time frame: From Day 1 until Follow up (Day 43)
Area under the plasma concentration-time (AUClast)
Time frame: From Day 1 until Follow up (Day 43)
Area under plasma concentration-time curve from zero to infinity (AUCinf)
Time frame: From Day 1 until Follow up (Day 43)
Time to reach maximum observed concentration (tmax)
Time frame: From Day 1 until Follow up (Day 43)
Terminal rate constant (λz)
Time frame: From Day 1 until Follow up (Day 43)
Terminal elimination half-life (t½λz)
Time frame: From Day 1 until Follow up (Day 43)
Total body clearance of drug from plasma (IV dosing only) (CL)
Time frame: From Day 1 until Follow up (Day 43)
Apparent total body clearance of drug from plasma (SC dosing only) (CL/F)
Time frame: From Day 1 until Follow up (Day 43)
Volume of distribution based on the terminal phase (IV dosing only) (Vz)
Time frame: From Day 1 until Follow up (Day 43)
Apparent volume of distribution based on the terminal phase (SC dosing only) (Vz/F)
Time frame: From Day 1 until Follow up (Day 43)
Dose-normalized AUClast (AUClast/D)
Time frame: From Day 1 until Follow up (Day 43)
Dose-normalized AUCinf (AUCinf/D)
Time frame: From Day 1 until Follow up (Day 43)
Dose-normalized Cmax (Cmax/D)
Time frame: From Day 1 until Follow up (Day 43)
Time of last observed (quantifiable) concentration (tlast)
Time frame: From Day 1 until Follow up (Day 43)
Prevalence and incidence of anti-drug antibodies (ADAs) to AZD6234
Time frame: Day 1, Day 15, Day 29 and at Follow up (Day 43)
ADA titer
Time frame: Day 1, Day 15, Day 29 and at Follow up (Day 43)
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 Dec 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD6234 and Acetaminophen in people with Healthy Participants, run by AstraZeneca at 2 sites 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 9 inclusion and 12 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 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Number of participants with AEs and Serious Adverse Events(SAE) (time frame: From Screening until Follow up (Day 43)). 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 26 Dec 2023.