Advanced Chronic Liver DiseasePhase 1CRIOLLONCT06973005
A Study to Investigate How Multiple Oral Doses of AZD2389 Affect the Pharmacokinetics of Midazolam, Caffeine, and Bupropion in Healthy Participants
A Phase 1 study testing AZD2389, Midazolam and Caffeine in people with Advanced Chronic Liver Disease and Healthy Participants, run by AstraZeneca at 1 site in United States.
Trial summary
The purpose of this study is to measure the effect of multiple doses of AZD2389 on the pharmacokinetics (PK) of midazolam, caffeine, and bupropion 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
- Advanced Chronic Liver Disease, Healthy Participants
- What is being tested?
- AZD2389, Midazolam and Caffeine
- 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
- 8 May 2025to 18 Jul 2025
- 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.
- Participants with suitable veins for cannulation or repeated venipuncture.
- Have a body mass index (BMI) between 18 and 32 kilograms per meter squared (kg/m2) inclusive and weigh at least 50 kilograms (kg) at Screening.
Who cannot join
- History of any clinically important disease or disorder which, in the opinion of the investigator, may either put the participant at risk.
- 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 study intervention.
- Any clinically important abnormalities in clinical chemistry, coagulation, hematology, or urinalysis results.
- Any positive result at the Screening Visit for serum hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
- Abnormal vital signs, after 10 minutes supine rest, at the Screening Visit and/or admission to the Clinical Unit (Day -2).
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- Any clinically important abnormalities in rhythm, conduction, or morphology of the resting 12-lead safety ECG.
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity.
- History of hypersensitivity to DPP4 inhibitors, as judged by the investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to DPP4 inhibitors.
- History of severe dermatological disorders, eg, bullous pemphigoid or Stevens-Johnson syndrome, as judged by the investigator.
- Participants who have previously received AZD2389 within the last 12 months prior to the Screening Visit.
- Known hypersensitivity or previous adverse events associated with midazolam, caffeine, or bupropion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Fixed Sequence Study in Healthy Participants to Assess the Effect of Multiple Doses of AZD2389 on the Pharmacokinetics of Midazolam, Caffeine, and Bupropion
The purpose of this study is to measure the effect of multiple doses of AZD2389 on the pharmacokinetics (PK) of midazolam, caffeine, and bupropion in healthy participants.
Read the detailed description
This study is an open-label, fixed sequence, 3-period, drug-drug interaction (DDI) study in healthy participants performed at a single Clinical Unit.
The study will comprise:
- A Screening Period of maximum 28 days.
- A Treatment Phase, separated into 3 different periods. Period 1 (Day -2 to Day 4): Participants will receive midazolam and caffeine in combination on Day 1. Participants will receive bupropion on Day 2.
Period 2 (Day 5 to Day 13): Participants will receive AZD2389 for 9 days. Period 3 (Day 14 to Day 18): Participants will first receive AZD2389 with midazolam and caffeine in combination on Day 14. On Day 15, participants will first receive AZD2389 with bupropion. On Days 16 and 17, participants will receive AZD2389.
- A final Follow-up Visit, 7 to 14 days after the last AZD2389 PK sample is taken in Period 3.
- Keywords
- Hepatic Fibrosis, FAP inhibitor
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD2389Drug
Oral dose on Days 5 to 13, Day 16, and Day 17. On Day 14 co-administered with a combination of midazolam and caffeine. On Day 15 co-administered with bupropion.
MidazolamDrug
Single oral dose on:
- Day 1 (co-administered with caffeine)
- Day 14 (co-administered with caffeine and AZD2389)
CaffeineDrug
Single oral dose on:
- Day 1 (co-administered with midazolam)
- Day 14 (co-administered with midazolam and AZD2389)
BupropionDrug
Single oral dose on:
- Day 2 (alone)
- Day 15 (co-administered with AZD2389)
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | In Period 1, participants will receive midazolam and caffeine in combination on Day 1. Participants will receive bupropion on Day 2.
In Period 2, participants will receive AZD2389 for 9 days from Day 5 to Day 13. In Period 3, participants will first receive AZD2389 with midazolam and caffeine in combination on Day 14. On Day 15, participants will first receive AZD2389 with bupropion. On Days 16 and 17, participants will receive AZD2389. Receives: Drug: AZD2389; Drug: Midazolam; Drug: Caffeine; Drug: Bupropion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of treatment to reference based on Cmax (RCmax)
To assess the PK parameter RCmax for midazolam, caffeine, and bupropion in combination with AZD2389 compared to midazolam, caffeine, and bupropion alone.
Measured: Period 1: Days 1-4; Period 2: Days 5-13; Period 3: Days 14-18.
Ratio of treatment to reference based on AUCinf (RAUCinf)
To assess the PK parameter RAUCinf for midazolam, caffeine, and bupropion in combination with AZD2389 compared to midazolam, caffeine, and bupropion alone.
Measured: Period 1: Days 1-4; Period 2: Days 5-13; Period 3: Days 14-18.
Ratio of treatment to reference based on AUClast (RAUClast)
To assess the PK parameter RAUClast for midazolam, caffeine, and bupropion in combination with AZD2389 compared to midazolam, caffeine, and bupropion alone.
Measured: Period 1: Days 1-4; Period 2: Days 5-13; Period 3: Days 14-18.
Ratio of area under concentration-curve from time 0 to 24 hours post-dose (AUC0-24)
To assess the PK parameter ratio of AUC0-24 for caffeine in combination with AZD2389 compared to caffeine alone.
Measured: Period 1: Days 1-3; Period 3: Days 15-18.
Secondary outcomes (18)
Apparent total body clearance (CL/F)
To describe the plasma PK of midazolam, caffeine, bupropion, and their metabolites (1'-OH-midazolam, paraxanthine, and hydroxy-bupropion) when midazolam, caffeine, or bupropion is administered alone and in combination with AZD2389. To describe the plasma PK of AZD2389 after multiple dose administration.
Measured: Period 1: Days 1-4; Period 2: Days 5-13; Period 3: Days 14-18.
Apparent volume of distribution based on the terminal phase (Vz/F)
To describe the plasma PK of midazolam, caffeine, bupropion, and their metabolites (1'-OH-midazolam, paraxanthine, and hydroxy-bupropion) when midazolam, caffeine, or bupropion is administered alone and in combination with AZD2389. To describe the plasma PK of AZD2389 after multiple dose administration.
Measured: Period 1: Days 1-4; Period 2: Days 5-13; Period 3: Days 14-18.
Terminal elimination half-life (t1/2λz)
To describe the plasma PK of midazolam, caffeine, bupropion, and their metabolites (1'-OH-midazolam, paraxanthine, and hydroxy-bupropion) when midazolam, caffeine, or bupropion is administered alone and in combination with AZD2389. To describe the plasma PK of AZD2389 after multiple dose administration.
Measured: Period 1: Days 1-4; Period 2: Days 5-13; Period 3: Days 14-18.
Terminal rate constant (λz)
To describe the plasma PK of midazolam, caffeine, bupropion, and their metabolites (1'-OH-midazolam, paraxanthine, and hydroxy-bupropion) when midazolam, caffeine, or bupropion is administered alone and in combination with AZD2389. To describe the plasma PK of AZD2389 after multiple dose administration.
Measured: Period 1: Days 1-4; Period 2: Days 5-13; Period 3: Days 14-18.
Time to reach maximum observed concentration (tmax)
To describe the plasma PK of midazolam, caffeine, bupropion, and their metabolites (1'-OH-midazolam, paraxanthine, and hydroxy-bupropion) when midazolam, caffeine, or bupropion is administered alone and in combination with AZD2389. To describe the plasma PK of AZD2389 after multiple dose administration.
Measured: Period 1: Days 1-4; Period 2: Days 5-13; Period 3: Days 14-18.
Maximum observed concentration (Cmax)
To describe the plasma PK of midazolam, caffeine, bupropion, and their metabolites (1'-OH-midazolam, paraxanthine, and hydroxy-bupropion) when midazolam, caffeine, or bupropion is administered alone and in combination with AZD2389. To describe the plasma PK of AZD2389 after multiple dose administration.
Measured: Period 1: Days 1-4; Period 2: Days 5-13; Period 3: Days 14-18.
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
To describe the plasma PK of midazolam, caffeine, bupropion, and their metabolites (1'-OH-midazolam, paraxanthine, and hydroxy-bupropion) when midazolam, caffeine, or bupropion is administered alone and in combination with AZD2389. To describe the plasma PK of AZD2389 after multiple dose administration.
Measured: Period 1: Days 1-4; Period 2: Days 5-13; Period 3: Days 14-18.
Area under concentration-time curve from time 0 to infinity (AUCinf)
To describe the plasma PK of midazolam, caffeine, bupropion, and their metabolites (1'-OH-midazolam, paraxanthine, and hydroxy-bupropion) when midazolam, caffeine, or bupropion is administered alone and in combination with AZD2389. To describe the plasma PK of AZD2389 after multiple dose administration.
Measured: Period 1: Days 1-4; Period 2: Days 5-13; Period 3: Days 14-18.
AUC0-24
To describe the plasma PK of caffeine and its metabolites (paraxanthine) when caffeine is administered alone and in combination with AZD2389.
Measured: Period 1: Days 1-3; Period 3: Days 15-18.
RCmax
To assess the RCmax for the metabolites of midazolam, caffeine, and bupropion (1'-OH-midazolam, paraxanthine, OH-bupropion) when midazolam, caffeine, or bupropion is administered alone and in combination with AZD2389.
Measured: Period 1: Days 1-4; Period 2: Days 5-13; Period 3: Days 14-18.
RAUCinf
To assess the RAUCinf for the metabolites of midazolam, caffeine, and bupropion (1'-OH-midazolam, paraxanthine, OH-bupropion) when midazolam, caffeine, or bupropion is administered alone and in combination with AZD2389.
Measured: Period 1: Days 1-4; Period 2: Days 5-13; Period 3: Days 14-18.
RAUClast
To assess the RAUClast for the metabolites of midazolam, caffeine, and bupropion (1'-OH-midazolam, paraxanthine, OH-bupropion) when midazolam, caffeine, or bupropion is administered alone and in combination with AZD2389.
Measured: Period 1: Days 1-4; Period 2: Days 5-13; Period 3: Days 14-18.
Ratio of treatment to reference based on AUC0-24 (RAUC0-24)
To assess the RAUC0-24 for the metabolites of caffeine, (paraxanthine) when caffeine is administered alone and in combination with AZD2389.
Measured: Period 1: Days 1-3; Period 3: Days 15-18.
Metabolite to parent ratio of the AUCinf
To assess the metabolite to parent ratio of the AUCinf for midazolam, caffeine, and bupropion.
Measured: Period 1: Days 1-4; Period 2: Days 5-13; Period 3: Days 14-18.
Metabolite to parent ratio of the AUC0-24
To assess the metabolite to parent ratio of the AUC0-24 for caffeine and its metabolite (paraxanthine) when caffeine is administered alone and in combination with AZD2389.
Measured: Period 1: Days 1-3; Period 3: Days 15-18.
Area under concentration-time curve in the dose interval (AUCtau)
To describe the plasma PK of AZD2389 after multiple dose administration.
Measured: Period 2: Days 5-13; Period 3: Day 14.
Observed lowest concentration before the next dose is administered (Ctrough)
To describe the plasma PK of AZD2389 after multiple dose administration.
Measured: Period 2: Days 5-13; Period 3: Day 14.
Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)
To assess the safety and tolerability of multiple oral doses of AZD2389 alone or in combination with midazolam, caffeine and bupropion in healthy participants.
Measured: Only SAE: -30 to -3 to Day -1. AE and SAE: From Day 1 to Follow-up/Early Termination Visit (Days 25-32)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start8 May 2025
- Primary completion18 Jul 2025
- Study completion18 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Chronic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 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
- NCT06973005
- Sponsor's protocol ID
- D7930C00007
- Acronym
- CRIOLLO
- Status last verified
- Jul 2025
- First submitted
- 7 May 2025
- Last updated
- 24 Jul 2025
- 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 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 shared.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Fixed Sequence Study in Healthy Participants to Assess the Effect of Multiple Doses of AZD2389 on the Pharmacokinetics of Midazolam, Caffeine, and Bupropion
- ClinicalTrials.gov ID
- NCT06973005
- Acronym / sponsor ID
- CRIOLLO / D7930C00007
- Keywords
- Hepatic Fibrosis, FAP inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 8 May 2025 (actual)
- Primary completion
- 18 Jul 2025 (actual)
- Study completion
- 18 Jul 2025 (actual)
- First posted
- 15 May 2025 (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.
The purpose of this study is to measure the effect of multiple doses of AZD2389 on the pharmacokinetics (PK) of midazolam, caffeine, and bupropion in healthy participants.
Detailed description
This study is an open-label, fixed sequence, 3-period, drug-drug interaction (DDI) study in healthy participants performed at a single Clinical Unit.
The study will comprise:
- A Screening Period of maximum 28 days.
- A Treatment Phase, separated into 3 different periods. Period 1 (Day -2 to Day 4): Participants will receive midazolam and caffeine in combination on Day 1. Participants will receive bupropion on Day 2.
Period 2 (Day 5 to Day 13): Participants will receive AZD2389 for 9 days. Period 3 (Day 14 to Day 18): Participants will first receive AZD2389 with midazolam and caffeine in combination on Day 14. On Day 15, participants will first receive AZD2389 with bupropion. On Days 16 and 17, participants will receive AZD2389.
- A final Follow-up Visit, 7 to 14 days after the last AZD2389 PK sample is taken in Period 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: AZD2389, Drug: Midazolam, Drug: Caffeine, Drug: BupropionIn Period 1, participants will receive midazolam and caffeine in combination on Day 1. Participants will receive bupropion on Day 2. In Period 2, participants will receive AZD2389 for 9 days from Day 5 to Day 13. In Period 3, participants will first receive AZD2389 with midazolam and caffeine in combination on Day 14. On Day 15, participants will first receive AZD2389 with bupropion. On Days 16 and 17, participants will receive AZD2389. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Provision of signed and dated, written informed consent prior to any study-specific procedures.
- Participants with suitable veins for cannulation or repeated venipuncture.
- Have a body mass index (BMI) between 18 and 32 kilograms per meter squared (kg/m2) inclusive and weigh at least 50 kilograms (kg) at Screening.
Key exclusion criteria (12 listed)
- History of any clinically important disease or disorder which, in the opinion of the investigator, may either put the participant at risk.
- 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 study intervention.
- Any clinically important abnormalities in clinical chemistry, coagulation, hematology, or urinalysis results.
- Any positive result at the Screening Visit for serum hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
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 |
|---|---|---|
| AZD2389Oral dose on Days 5 to 13, Day 16, and Day 17. On Day 14 co-administered with a combination of midazolam and caffeine. On Day 15 co-administered with bupropion. | Drug | Treatment Arm |
| MidazolamSingle oral dose on: * Day 1 (co-administered with caffeine) * Day 14 (co-administered with caffeine and AZD2389) | Drug | Treatment Arm |
| CaffeineSingle oral dose on: * Day 1 (co-administered with midazolam) * Day 14 (co-administered with midazolam and AZD2389) | Drug | Treatment Arm |
| BupropionSingle oral dose on: * Day 2 (alone) * Day 15 (co-administered with AZD2389) | Drug | Treatment Arm |
Primary outcome
Ratio of treatment to reference based on Cmax (RCmax)
Time frame: Period 1: Days 1-4; Period 2: Days 5-13; Period 3: Days 14-18.
To assess the PK parameter RCmax for midazolam, caffeine, and bupropion in combination with AZD2389 compared to midazolam, caffeine, and bupropion alone.
Ratio of treatment to reference based on AUCinf (RAUCinf)
Time frame: Period 1: Days 1-4; Period 2: Days 5-13; Period 3: Days 14-18.
To assess the PK parameter RAUCinf for midazolam, caffeine, and bupropion in combination with AZD2389 compared to midazolam, caffeine, and bupropion alone.
Ratio of treatment to reference based on AUClast (RAUClast)
Time frame: Period 1: Days 1-4; Period 2: Days 5-13; Period 3: Days 14-18.
To assess the PK parameter RAUClast for midazolam, caffeine, and bupropion in combination with AZD2389 compared to midazolam, caffeine, and bupropion alone.
Ratio of area under concentration-curve from time 0 to 24 hours post-dose (AUC0-24)
Time frame: Period 1: Days 1-3; Period 3: Days 15-18.
To assess the PK parameter ratio of AUC0-24 for caffeine in combination with AZD2389 compared to caffeine alone.
18 secondary outcomes
Apparent total body clearance (CL/F)
Time frame: Period 1: Days 1-4; Period 2: Days 5-13; Period 3: Days 14-18.
Apparent volume of distribution based on the terminal phase (Vz/F)
Time frame: Period 1: Days 1-4; Period 2: Days 5-13; Period 3: Days 14-18.
Terminal elimination half-life (t1/2λz)
Time frame: Period 1: Days 1-4; Period 2: Days 5-13; Period 3: Days 14-18.
Terminal rate constant (λz)
Time frame: Period 1: Days 1-4; Period 2: Days 5-13; Period 3: Days 14-18.
Time to reach maximum observed concentration (tmax)
Time frame: Period 1: Days 1-4; Period 2: Days 5-13; Period 3: Days 14-18.
Maximum observed concentration (Cmax)
Time frame: Period 1: Days 1-4; Period 2: Days 5-13; Period 3: Days 14-18.
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
Time frame: Period 1: Days 1-4; Period 2: Days 5-13; Period 3: Days 14-18.
Area under concentration-time curve from time 0 to infinity (AUCinf)
Time frame: Period 1: Days 1-4; Period 2: Days 5-13; Period 3: Days 14-18.
AUC0-24
Time frame: Period 1: Days 1-3; Period 3: Days 15-18.
RCmax
Time frame: Period 1: Days 1-4; Period 2: Days 5-13; Period 3: Days 14-18.
RAUCinf
Time frame: Period 1: Days 1-4; Period 2: Days 5-13; Period 3: Days 14-18.
RAUClast
Time frame: Period 1: Days 1-4; Period 2: Days 5-13; Period 3: Days 14-18.
Ratio of treatment to reference based on AUC0-24 (RAUC0-24)
Time frame: Period 1: Days 1-3; Period 3: Days 15-18.
Metabolite to parent ratio of the AUCinf
Time frame: Period 1: Days 1-4; Period 2: Days 5-13; Period 3: Days 14-18.
Metabolite to parent ratio of the AUC0-24
Time frame: Period 1: Days 1-3; Period 3: Days 15-18.
Area under concentration-time curve in the dose interval (AUCtau)
Time frame: Period 2: Days 5-13; Period 3: Day 14.
Observed lowest concentration before the next dose is administered (Ctrough)
Time frame: Period 2: Days 5-13; Period 3: Day 14.
Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Only SAE: -30 to -3 to Day -1. AE and SAE: From Day 1 to Follow-up/Early Termination Visit (Days 25-32)
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 24 Jul 2025.
- 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 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 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 AZD2389, Midazolam and Caffeine in people with Advanced Chronic Liver Disease and 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 3 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 24 Jul 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. 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?
Ratio of treatment to reference based on Cmax (RCmax) (time frame: Period 1: Days 1-4; Period 2: Days 5-13; Period 3: Days 14-18.). 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?
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 24 Jul 2025.