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Opioid Use DisorderPhase 1NCT06406400

Drug-Drug Interaction and Safety of AZD4041 Study (Part 1) and Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of AZD4041 Study in Opioid Use Disorder (Part 2).

A Phase 1 study testing AZD4041, Itraconazole and Buprenorphine in people with Opioid Use Disorder, run by AstraZeneca at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of the study is to assess drug-drug interaction (DDI) and safety of AZD4041 and itraconazole in healthy participants (Part 1), and to assess efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of AZD404 when administered with buprenorphine/buprenorphine + naloxone in participants with… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Opioid Use Disorder
What is being tested?
AZD4041, Itraconazole and Buprenorphine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
15 participants
Where
1 siteUnited States
Study dates
13 May 2024to 31 Jul 2024
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male participants:
  • with female partner(s) of childbearing potential (including breastfeeding partner) must be willing to use a reliable method of contraception throughout the study period for 30 days) after final investigational medicinal product (IMP) administration for Part 1a, and for 5 drug elimination half-lives after final IMP administration for Part 1b and Part 2.
  • must not donate sperm starting at screening and throughout the study period and for 30 days) after final IMP administration for Part 1a and for 5 drug elimination half-lives after final IMP administration for Part 1b and Part 2.
  • with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for 5 drug elimination half-lives after final IMP administration.
  • Part 1
  • Body mass index (BMI) within 18.0 kg/m2 to 30.0 kg/m2, inclusive.
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  • Body weight of within 50 kg to 100 kg, inclusive.
  • Non- or ex-smoker (an ex-smoker is defined as someone who completely stopped using nicotine products for at least 180 days prior to the first drug administration).
  • Part 2
  • BMI within the range of ≥ 18 and ≤ 35 kg/m2 at the screening visit.
  • Participant has a diagnosis of moderate to severe OUD according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) using the Mini International Neuropsychiatric Interview (MINI) version 7.02.
  • Participant is voluntarily seeking treatment for OUD.
  • Participant is not currently receiving Medication for Opioid Use Disorder (MOUD), and has not received MOUD within 60 days prior to screening and is:
  • Willing to initiate buprenorphine therapy;
  • Considered to be a good candidate for buprenorphine treatment based on medical and psychosocial history;
  • Has a positive urine drug screen at the initial screening visit and Day -1 for opioids. These may include morphine and metabolites, diacetylmorphine (heroin), codeine, oxycodone, hydrocodone, hydromorphone, fentanyl and metabolites, propoxyphene or oxymorphone.
  • Female participants:
  • must not donate ova starting at screening and throughout the study period and 5 drug elimination half-lives after final IMP administration.
  • must not be planning to become pregnant during the study and at least one of the following conditions apply:
  • Woman of non-childbearing potential (WONCBP) and/or
  • Woman of childbearing potential who agrees to follow the contraceptive guidance from the time of informed consent until at least for 5 drug elimination half-lives after final IMP administration.

Who cannot join

  • Participant has a history of attempted suicide or suicidal behavior within 12 months prior to screening or has any suicidal ideation that meets criteria at a level of 4 or 5 by using the Columbia Suicide Severity Rating Scale (C-SSRS) within 12 months prior to Screening or who is at significant risk to commit suicide, as assessed at Screening and at Day -1.
  • Male participants with a history of oligospermia or azoospermia or any other disorder of the reproductive system or who are undergoing treatment or evaluation for infertility.
  • Females who are lactating or pregnant according to the pregnancy test at Screening or prior to the first study intervention administration.
  • A family history of long QT syndrome.
  • Any abnormal or clinically significant findings in laboratory test results at Screening.
  • Participant has HIV per screening serology test.
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  • Any clinically important abnormalities in rhythm, conduction, or morphology of the resting electrocardiogram (ECG) and any clinically important abnormalities in the 12-lead ECG.
  • History of significant allergy/ hypersensitivity to AZD4041 or to products related to AZD4041 or other study drugs (including excipients of the formulation), as well as history of severe allergy/hypersensitivity reactions (like angioedema) to any drugs.
  • Any vaccination (including with COVID-19 vaccine) less than 14 days prior to first study intervention administration.
  • Participants who have a history of exposure to psilocybin and 3,4-methylenedioxymethamphetamine (MDMA) within the last 3 months.
  • Part 1 Only:
  • Past medical history of any clinically significant systemic illness including (but not necessarily limited to) cardiovascular, gastrointestinal, pulmonary, hematologic, neurological, hepatic, endocrinologic, metabolic, genito-urinary, musculoskeletal, immunologic, dermatologic, renal and/or major disease.
  • Maintenance therapy with any drug for long-term chronic conditions or significant history of drug dependency or alcohol abuse (> 21 units/week or > 3 units/day for men; > 14 units/week or > 2 units/day for women; intake of excessive alcohol, acute or chronic).
  • History of any significant psychiatric disorder according to the criteria of the Diagnostic and Statistical manual of Mental Disorders, 5th Edition (American Psychiatric Association 2013).
  • History of any substance use disorder (as per DSM-5 criteria).
  • Any clinically significant, medical/surgical procedure or trauma within the 28 days prior to the first study intervention administration.
  • Positive urine test result for drugs of abuse or cotinine (nicotine), at Screening or prior to the first study intervention administration
  • Positive screening results to hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV) tests.
  • Use of any prescription drugs, including hormone replacement therapy in the 28 days prior to the first study intervention administration.
  • Excessive intake of caffeine-containing drinks or food (e.g., coffee, tea, chocolate) as judged by an Investigator.
  • Presence of any tongue piercings or history of any tongue piercings in the last 90 days prior to the first study intervention administration.
  • Participants who have medical dietary restrictions.
  • Participants with a known hypersensitivity to itraconazole (Part 1a only).
  • Part 2 Only:
  • Participant with clinically significant and uncontrolled cardiovascular, gastrointestinal, pulmonary, hematological, neurological, hepatic, endocrinal, metabolic, musculoskeletal, immunologic, dermatologic, renal and/or any other major disease.
  • Participants with a history of severe respiratory insufficiency, obstructive sleep apnea not controlled by a continuous positive airway pressure device or narcolepsy or current clinically significant infections.
  • Current diagnosis of chronic pain and who require treatment with opioids.
  • Participant has an active malignancy or a history of malignancy (except for treated non-melanoma skin cancer) within 5 years of screening.
  • Participant has a history of respiratory depression while on buprenorphine-based or other MOUD.
  • Participants with active signs or symptoms of hepatitis and requiring treatment; or known or suspected chronic liver disease, including cirrhosis or significant liver fibrosis.
  • Participants with current HCV infection.
  • Hepatitis B Virus (HBV) infection: Participants with positive hepatitis B surface antigen (HbsAg) or those with a history of Hepatitis B viral infection.
  • Participant has known kidney disease and a glomerular filtration rate (GFR) < 60 mL/min/m2 at screening.
  • Participant has comorbid major psychiatric disorders specifically schizophrenia, bipolar disorder or severe major depressive disorder.
  • Moderate to severe substance use disorder on any other psychoactive substances (by DSM 5) other than opioids, caffeine or nicotine (eg, alcohol, sedatives).
  • If a participant is currently diagnosed with abuse of or dependence on alcohol, the participant will not be allowed to enrol in the study, unless the alcohol abuse/dependence is in full (complete, not partial), sustained (> 1 year) remission.
  • Participants who need to be on prescription central nervous system (CNS) depressant medications including benzodiazepines, during the trial (other than the study interventions).
  • Participant has a positive urine drug screen (UDS) results for barbiturates or benzodiazepines at screening or Day -1.
  • Participant has a positive urine test for buprenorphine on Day -1.
  • Participants with a known hypersensitivity to buprenorphine, naloxone, other opioids or any components of the formulations used.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Research Site

    Baltimore, Maryland, 21225

Other trials in United States

About this study

Official title: A Two-Part Study to Examine the Drug-Drug Interaction With Itraconazole and Safety of AZD4041 in Healthy Participants and the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of AZD4041 as an Adjunctive Treatment to Buprenorphine in Participants With Moderate to Severe Opioid Use Disorder

The purpose of the study is to assess drug-drug interaction (DDI) and safety of AZD4041 and itraconazole in healthy participants (Part 1), and to assess efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of AZD404 when administered with buprenorphine/buprenorphine + naloxone in participants with moderate to severe opioid use disorder (OUD)

Read the detailed description

This study will be conducted in 2 sequential parts.

Part 1 (Phase I) will include healthy participants and will be conducted as two separate parts. Part 1a (DDI cohort) is an open-label, fixed sequence study part which will comprise of:

  • A Screening Period from Day -28 to Day -3.
  • Three treatment periods:
  • Period 1 (Day -2 to Day 5): Participants will be admitted to the clinical unit on Day -2 and will receive a single oral dose of AZD4041 on Day 1. There will be a 5-day washout period.
  • Period 2 (Day 6 to Day 8): Participants will receive itraconazole for 3 days from Day 6 through Day 8.
  • Period 3 (Day 9 to Day 22): On Day 9, participants will receive single oral dose of AZD4041 co-administered with itraconazole. Itraconazole alone will be administered from Day 10 to Day 21.
  • A Follow-up Visit: Participants will return to the clinical unit at least 7 days and no later than 14 days after discharge.

Based on the results from Part 1a, an optional part of the study (Part 1b) may be conducted to assess the safety tolerability and PK of AZD4041 after a single oral dose. Part 1b (Single Dose Cohort) will be a randomized, placebo-controlled, double-blind (participant and investigator blinded) study part conducted in healthy participants. This study part will comprise of the following:

  • A Screening Period from Day -28 to Day -3.
  • A Treatment Period: Participants will be admitted to the clinical unit on Day -2 and will remain in the unit until Day 4, when they will be discharged after completion of all assessments.
  • A Follow-up Visit: Participant will return to the clinical unit at least 12 days and no greater than 16 days after the last AZD4041 PK sample.

The results from Part 1 will determine the AZD4041 dose selection and safety margin to be used in Part 2.

Part 2 (Phase IIa) will be a randomized, placebo-controlled, double-blind study. Participants will be randomized to 1 of 2 treatment arms, AZD4041 or placebo, in a 1:1 ratio. Part 2 will consist of:

  • A Screening Period from Day -21 to Day -2.
  • A Treatment Period: Participants will be admitted to the clinical unit on Day -1 and will receive either AZD4041 or placebo with hydromorphone (as a replacement opioid) on Days 1, 2 and 3, and buprenorphine/buprenorphine + naloxone (as a standard of care for their opioid withdrawal) on Days 4, 5, 6 and 7. Participants who complete the treatment period will have continued access to Suboxone (buprenorphine + naloxone) during their Follow-up period, which will be supplied to participants at discharge (Day 7).
  • A Follow-up Visit: Participant will return to the clinical unit at least 7 days and no greater than 9 days after the last AZD4041 dose.
Being tested
AZD4041, Itraconazole, Buprenorphine, Buprenorphine / Naloxone, Hydromorphone
Keywords
Drug-drug interactions, Adjunctive treatment, Itraconazole, Buprenorphine, Naloxone, Pharmacokinetics
Medical subject headings
Opioid-Related Disorders

What participants receive

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

  • AZD4041Drug

    Part 1a: Healthy participants will receive AZD4041 (Dose 1) orally on Day 1 and Day 9.

    Part 1b: Healthy participants will receive AZD4041 (Dose 2) orally on Day 1 as a single dose.

    Part 2: Participants with OUD will receive daily doses of AZD4041 from Days 1 to 7.

  • ItraconazoleDrug

    Also called Sporanox®

    Healthy participants will receive itraconazole orally from Days 6 to 8 in Period 2 and Days 9 to 21 in Period 3.

  • BuprenorphineDrug

    Also called Belbuca®

    Participants with OUD will receive buprenorphine (as standard of care treatment) on Day 4.

  • Buprenorphine / NaloxoneDrug

    Also called Suboxone®

    Participants with OUD will receive buprenorphine + naloxone (as standard of care treatment) on Days 4, 5, 6 and 7

  • HydromorphoneDrug

    Also called Dilaudid®

    Participants with OUD will receive hydromorphone (as a replacement opioid) on Days 1, 2 and 3.

  • PlaceboDrug

    Part 1b: Healthy participants will receive matching placebo orally on Day 1 as a single dose.

    Part 2: Participants with OUD will receive placebo daily from Days 1 to 7.

Study groups in NCT06406400
Study groupRoleWhat they receive
Part 1a: AZD4041 (Dose 1) and ItraconazoleExperimentalHealthy participants will receive a single dose of AZD4041 (Dose 1) in period 1, followed by repeat dose of itraconazole for 3 days in period 2, and a single dose of AZD4041 co-administered with itraconazole on Day 9, followed by continued itraconazole daily dosing until Day 21 in period 3.
Receives: Drug: AZD4041; Drug: Itraconazole
Part 1b: AZD4041 (Dose 2)ExperimentalHealthy participants will receive AZD4041 (Dose 2) orally as a single dose.
Receives: Drug: AZD4041
Part 1b: PlaceboPlacebo comparatorHealthy participants will receive matching placebo orally as a single dose.
Receives: Drug: Placebo
Part 2: AZD4041 (Dose 3)ExperimentalParticipants will receive AZD4041 (Dose 3) with hydromorphone on Days 1, 2 and 3, and buprenorphine/buprenorphine + naloxone on Days 4, 5, 6 and 7.
Receives: Drug: AZD4041; Drug: Buprenorphine; Drug: Buprenorphine / Naloxone; Drug: Hydromorphone
Part 2: PlaceboPlacebo comparatorParticipants will receive matching placebo with hydromorphone on Days 1, 2 and 3, and buprenorphine/buprenorphine + naloxone on Days 4, 5, 6 and 7.
Receives: Drug: Buprenorphine; Drug: Buprenorphine / Naloxone; Drug: Hydromorphone; Drug: Placebo

What is being measured

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

  1. Part 1a: Maximum observed drug concentration (Cmax) of AZD4041

    To assess the effect of itraconazole on the PK of a AZD4041 single oral dose.

    Measured: Day 1 to Day 5, Day 9 to Day 22

  2. Part 1a: Area under concentration-time curve from time 0 to infinity (AUCinf) of AZD4041

    To assess the effect of itraconazole on the PK of a AZD4041 single oral dose.

    Measured: Day 1 to Day 5, Day 9 to Day 22

  3. Part 1b: Number of participants with adverse events (AEs) and serious adverse events (SAEs)

    To assess the safety and tolerability of AZD4041 following oral administration of a single dose.

    Measured: For SAE - From screening (Day -28 to Day -3), For AE - From Treatment period (Day 1) up to Follow-Up Visit [Day 7 (+ 2 days) post-dose]

  4. Part 2: Change from baseline in Self-reported withdrawal symptoms measured by the Short Opioid Withdrawal Scale-Gossop (SOWS-G)

    To evaluate the effects of AZD4041, as an adjunctive treatment to buprenorphine when administered after hydromorphone, on clinical measures of withdrawal in participants with OUD.

    SOWS-G is a 10-item psychometrically validated scale that measures participant reported withdrawal symptoms. Each of the items of the scale is scored as follows: none=0; mild=1; moderate=2; severe=3. The SOWS-G score is computed as the total sum of the item scores (giving a range for SOWS-G scores of 0 - 30). A high score indicates more severe withdrawal symptoms.

    Measured: From Day 4 pre-dose value (Day 4 baseline) to last Day 4 evaluation

Secondary outcomes (14)

  1. Part 1a: Number of participants with adverse events (AEs) and serious adverse events (SAEs)

    To assess the safety and tolerability of AZD4041 alone and in combination with itraconazole.

    Measured: For SAE - From screening (Day -28 to Day -3), For AE - From Treatment period (Day 1) to Follow-up visit (7-14 days after last PK sample)

  2. Part 1a and Part 1b: Time to Maximum Concentration (tmax) of AZD4041

    Part 1a: To characterize the PK of AZD4041 following oral administration of a single dose of AZD4041 alone and in combination with itraconazole.

    Part 1b: To characterize the PK of AZD4041 following oral administration of a single dose of AZD4041.

    Measured: Part 1a: Day 1 to Day 5 and Day 9 to Day 22; Part 1b: Day 1 to Day 4

  3. Part 1a and Part 1b: Area under concentration-time curve from time 0 to the last quantifiable concentration (AUClast) of AZD4041

    Part 1a: To characterize the PK of AZD4041 following oral administration of a single dose of AZD4041 alone and in combination with itraconazole.

    Part 1b: To characterize the PK of AZD4041 following oral administration of a single dose of AZD4041.

    Measured: Part 1a: Day 1 to Day 5 and Day 9 to Day 22; Part 1b: Day 1 to Day 4

  4. Part 1a: Area under concentration-time curve from time 0 to 72h (AUC0-72) of AZD4041

    To characterize the PK of AZD4041 following oral administration of a single dose of AZD4041 alone and in combination with itraconazole.

    Measured: Day 1 to Day 5 (72 h) post dose, Day 9 to Day 22 (72 h) post dose

  5. Part 1a and Part 1b: Terminal elimination half-life (t1/2λz) of AZD4041

    Part 1a: To characterize the PK of AZD4041 following oral administration of a single dose of AZD4041 alone and in combination with itraconazole.

    Part 1b: To characterize the PK of AZD4041 following oral administration of a single dose of AZD4041.

    Measured: Part 1a: Day 1 to Day 5 and Day 9 to Day 22; Part 1b: Day 1 to Day 4

  6. Part 1a and Part 1b: Apparent total body clearance (CL/F) of AZD4041

    Part 1a: To characterize the PK of AZD4041 following oral administration of a single dose of AZD4041 alone and in combination with itraconazole.

    Part 1b: To characterize the PK of AZD4041 following oral administration of a single dose of AZD4041.

    Measured: Part 1a: Day 1 to Day 5 and Day 9 to Day 22; Part 1b: Day 1 to Day 4

  7. Part 1a and Part 1b: Apparent volume of distribution based on the terminal phase (Vz/F) of AZD4041

    Part 1a: To characterize the PK of AZD4041 following oral administration of a single dose of AZD4041 alone and in combination with itraconazole.

    Part 1b: To characterize the PK of AZD4041 following oral administration of a single dose of AZD4041.

    Measured: Part 1a: Day 1 to Day 5 and Day 9 to Day 22; Part 1b: Day 1 to Day 4

  8. Part 1b: Maximum observed drug concentration (Cmax) of AZD4041

    To characterize the PK of AZD4041 following oral administration of a single dose of AZD4041.

    Measured: Day 1 to Day 4

  9. Part 1b: Area under concentration-time curve from time 0 to infinity (AUCinf) of AZD4041

    To characterize the PK of AZD4041 following oral administration of a single dose of AZD4041.

    Measured: Day 1 to Day 4

  10. Part 2: Number of participants with adverse events (AEs) and serious adverse events (SAEs)

    To evaluate the safety and tolerability of AZD4041 when administered sequentially in combination with hydromorphone then buprenorphine in participants with OUD.

    Measured: For SAE - From screening (Day -21 to Day -2), For AE - From Treatment period (Day 1) to Follow-up Visit [7 (+ 2 days) days post-last dose]

  11. Part 2: Plasma concentrations of AZD4041

    To evaluate the PK of AZD4041 after repeat doses, as an adjunctive treatment to buprenorphine when administered after hydromorphone, in participants with OUD.

    Measured: From Baseline (Day 1) to Day 7

  12. Part 2: Change from baseline in Self-reported withdrawal symptoms measured by the Short Opioid Withdrawal Scale-Gossop (SOWS-G)

    To evaluate the effects of AZD4041, when administered sequentially in combination with hydromorphone then buprenorphine on clinical measures of withdrawal and craving in participants with OUD.

    Measured: Days 1-3; Day 4; Days 1-7 and Days 4-7

  13. Part 2: Change from baseline in Observer rated withdrawal symptoms measured by the Clinical Opioid Withdrawal Scale (COWS)

    To evaluate the effects of AZD4041, when administered sequentially in combination with hydromorphone then buprenorphine on clinical measures of withdrawal and craving in participants with OUD.

    The COWS is an 11-item, validated scale that measures clinician rated opioid withdrawal symptoms in OUD. It has the following scoring range:

    5-12 = mild; 13-24 = moderate; 25-36 = moderately severe; more than 36 = severe withdrawal.

    Measured: Days 1-3; Day 4; Days 1-7 and Days 4-7

  14. Part 2: Change from baseline in Self-reported craving as measured by the 3-item Opioid Craving Visual Analog Scale (VAS) [OCV]

    To evaluate the effects of AZD4041, when administered sequentially in combination with hydromorphone then buprenorphine on clinical measures of withdrawal and craving in participants with OUD.

    OCV will be used to measure participant reported craving symptoms. The OCV is composed of three 0 to 100 point VAS scales anchored at 0 (not at all) and 100 (extreme).

    Measured: Days 1-3; Day 4; Days 1-7 and Days 4-7

Timeline

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

  1. First posted9 May 2024
  2. Study start13 May 2024
  3. Primary completion31 Jul 2024
  4. Study completion31 Jul 2024

Why it stopped: Study terminated due to discontinuation of the AZD4041 clinical development program for OUD.

Resources

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06406400
Sponsor's protocol ID
D7460C00004
Status last verified
Mar 2025
First submitted
6 May 2024
Last updated
26 Mar 2025
Results posted
No
Data monitoring committee
Yes
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 Vivli.org. 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 approved.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AZD4041, Itraconazole and Buprenorphine in people with Opioid Use Disorder, 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 21 inclusion and 40 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: stopped early, as of the sponsor's last update on 26 Mar 2025. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Study terminated due to discontinuation of the AZD4041 clinical development program for OUD.). Results are not available in the source record.

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?

Part 1a: Maximum observed drug concentration (Cmax) of AZD4041 (time frame: Day 1 to Day 5, Day 9 to Day 22). The study lists 4 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 NCT06406400.

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 Mar 2025.

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