Healthy Study ParticipantsPhase 1NCT06679413
A Study to Assess Drug-drug Interaction of ZX008 in Healthy Male and Female Study Participants
A Phase 1 study testing midazolam, metformin and bupropion in people with Healthy Study Participants, run by UCB BIOSCIENCES, Inc. at 1 site in United States.
Trial summary
The purpose of the study is to assess the single-dose pharmacokinetics (PK) of 3 probe drugs (midazolam, bupropion, and metformin) before and after repeat doses of ZX008 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Study Participants
- What is being tested?
- midazolam, metformin and bupropion
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2024to 12 Jun 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Participant must be 18 to 55 years of age inclusive at the time of signing the informed consent form (ICF)
- Body weight of at least 50 kg and body mass index within the range 18 to 32 kg/m^2 (inclusive)
- Male or female
- Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Who cannot join
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) above 1.1x upper limit of normal (ULN)
- Bilirubin >ULN (isolated bilirubin <1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
- Participant has clinically significant current or past history of cardiovascular or cerebrovascular disease, such as valvular heart disease, and/or pulmonary hypertension. Participants with any history of stroke or myocardial infarction are excluded.
- Clinically significant history or presence of electrocardiogram (ECG) or echocardiogram (ECHO) findings as judged by the investigator or designee at the Screening Visit and Check-in, including each criterion listed below:
- Abnormal sinus rhythm (heart rate outside of 40bpm and 100bpm)
- QTcF (QT interval corrected using Fridericia's formula) interval >450 msec for male participants or >470 msec for female participants (QTcF is the QT interval corrected for heart rate according to Fridericia's formula, it can be either machine read or manually overread)
Show all 23Show fewer
- QRS interval >120 msec, confirmed by manual over read
- PR interval >220 msec
- Greater than trace aortic valve regurgitation
- Greater than trace mitral valve regurgitation
- Possible signs of pulmonary arterial hypertension (PAH) with abnormal pulmonary artery systolic pressure (PASP) or PASP >35 mmHg
- Evidence of left ventricular dysfunction (systolic or diastolic)
- Clinically significant structural cardiac abnormality, including, but not limited to, mitral valve prolapse, atrial or ventricular septal defects, and patent ductus arteriosus with reversal of shunt (right to left shunt). Note: Patent foramen ovale or a bicuspid aortic valve is not considered exclusionary
- Clinically significant abnormal blood pressure (as determined by the investigator)
- Participant has a current or past history of glaucoma
- Participant has used hepatic enzyme-inducing drugs (eg, glucocorticoids, phenobarbital, isoniazid, phenytoin, rifampicin) within 30 days before the first administration of the cocktail of 3 probe drugs (metformin, midazolam, bupropion) and through the day of discharge from the site
- Participant has used other prescription drugs, including vaccinations, over-the-counter medications, herbal/traditional medicines, or dietary supplements within 14 days before the first administration of the cocktail of probe drugs (excluding medicines for external use), with the exception of acetaminophen (up to 2 g/day)
- Consent to genotyping is required for participation in the study. Poor metabolizers of CYP (cytochrome P450) 3A4 or CYP2B6 based on genotyping and as categorized by the testing laboratory will be excluded from the study
- Positive test for alcohol and/or prohibited concomitant drugs (including cotinine) at Screening Visit and on Day -1
- Participant has donated blood or plasma or has experienced blood loss ≥500 mL within 90 days, ≥200 mL within 30 days, or has donated any blood or plasma within 14 days before first administration of study treatments
- Any consumption of food products with a known Drug-drug interaction (DDI) impact (eg, grapefruit, grapefruit juice, Seville oranges, or products containing them) for at least 1 week before Day 1 and through day of discharge from the site
- Consumption of more than 600 mg of caffeine/day (1 cup of coffee contains approximately 100 mg of caffeine, 1 cup of tea approximately 30 mg, and 1 glass of cola approximately 20 mg) within 30 days before Day 1 and through day of discharge from the site
- Participant is a current smoker or has used nicotine-containing products (eg, tobacco, patches, gum, vapes, or e-cigarettes) within 35 days before Day 1 and through day of discharge from the site
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Single-Center, Repeat-Dose, Open-Label, Fixed-Sequence Drug-Drug Interaction Study of ZX008 in Healthy Male Or Female Study Participants 18 To 55 Years Of Age
The purpose of the study is to assess the single-dose pharmacokinetics (PK) of 3 probe drugs (midazolam, bupropion, and metformin) before and after repeat doses of ZX008
- Conditions
- Healthy Study Participants
- Keywords
- Healthy Study Participants, fenfluramine HCl, Drug-drug interaction, Phase 1, ZX008
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
midazolamDrug
Study participants will receive a pre specified single oral dose of probe drug midazolam on Day 1 and Day 22 of the study
metforminDrug
Study participants will receive a pre-specified single oral dose of probe drug metformin on Day 1 and Day 22 of the study
bupropionDrug
Study participants will receive a pre-specified single oral dose of probe drug bupropion on Day 1 and Day 22 of the study
fenfluramine HClDrug
Also called Fintepla, ZX0008
Study participants will receive pre-specified repeated oral doses of fenfluramine HCl (ZX008) from Day 6 to 26 during the study
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Study participants will receive a single dose of the cocktail of probe drugs at pre-specified timepoints followed by a wash out period. The same study participants will then receive repeated oral doses of fenfluramine HCl (ZX008) and a single dose of the cocktail of probe drugs at pre-specified time points during this Treatment Period. Receives: Drug: midazolam; Drug: metformin; Drug: bupropion; Drug: fenfluramine HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Concentration (Cmax) of Midazolam Alone and in Combination With ZX008 at Steady State
Cmax is the maximum observed plasma concentration of Midazolam alone and in combination with ZX008 at steady state.
Measured: Day 1 (Treatment Period 1) and Day 22 (Treatment Period 2): Predose, 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 10,12, 24, 36, 48, 72, and 96 hours Postdose
Maximum Concentration (Cmax) of Metformin Alone and in Combination With ZX008 at Steady State
Cmax is the maximum observed plasma concentration of Metformin alone and in combination with ZX008 at steady state.
Measured: Day 1 (Treatment Period 1) and Day 22 (Treatment Period 2): Predose, 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 10,12, 24, 36, 48, 72, and 96 hours Postdose
Maximum Concentration (Cmax) of Bupropion Alone and in Combination With ZX008 at Steady State
Cmax is the maximum observed plasma concentration of Bupropion alone and in combination with ZX008 at steady state.
Measured: Day 1 (Treatment Period 1) and Day 22 (Treatment Period 2): Predose, 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 10,12, 24, 36, 48, 72, and 96 hours Postdose
Area Under the Curve From 0 to Infinity (AUC) of Midazolam Alone and in Combination With ZX008 at Steady State
AUC is area under the plasma concentration-time curve from time 0 to infinity of Midazolam alone and in combination with ZX008 at steady state.
Measured: Day 1 (Treatment Period 1) and Day 22 (Treatment Period 2): Predose, 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 10,12, 24, 36, 48, 72, and 96 hours Postdose
Area Under the Curve From 0 to Infinity (AUC) of Metformin Alone and in Combination With ZX008 at Steady State
AUC is area under the plasma concentration-time curve from time 0 to infinity of Metformin alone and in combination with ZX008 at steady state.
Measured: Day 1 (Treatment Period 1) and Day 22 (Treatment Period 2): Predose, 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 10,12, 24, 36, 48, 72, and 96 hours Postdose
Area Under the Curve From 0 to Infinity (AUC) of Bupropion Alone and in Combination With ZX008 at Steady State
AUC is area under the plasma concentration-time curve from time 0 to infinity of Bupropion alone and in combination with ZX008 at steady state.
Measured: Day 1 (Treatment Period 1) and Day 22 (Treatment Period 2): Predose, 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 10,12, 24, 36, 48, 72, and 96 hours Postdose
Area Under the Curve From 0 to the Time of the Last Quantifiable Concentration AUC(0-t) of Midazolam Alone and in Combination With ZX008 at Steady State
AUC(0-t) is area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration of Midazolam alone and in combination with ZX008 at steady state.
Measured: Day 1 (Treatment Period 1) and Day 22 (Treatment Period 2): Predose, 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 10,12, 24, 36, 48, 72, and 96 hours Postdose
Area Under the Curve From 0 to the Time of the Last Quantifiable Concentration AUC(0-t) of Metformin Alone and in Combination With ZX008 at Steady State
AUC(0-t) is area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration of Metformin alone and in combination with ZX008 at steady state.
Measured: Day 1 (Treatment Period 1) and Day 22 (Treatment Period 2): Predose, 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 10,12, 24, 36, 48, 72, and 96 hours Postdose
Area Under the Curve From 0 to the Time of the Last Quantifiable Concentration AUC(0-t) of Bupropion Alone and in Combination With ZX008 at Steady State
AUC(0-t) is area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration of Bupropion alone and in combination with ZX008 at steady state.
Measured: Day 1 (Treatment Period 1) and Day 22 (Treatment Period 2): Predose, 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 10,12, 24, 36, 48, 72, and 96 hours Postdose
Secondary outcomes (1)
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A treatment-emergent adverse events was defined as any AE with a start date and time on or after the first dose of any study drug or any unresolved event already present before treatment administration that worsens infrequency or intensity following exposure to any of the study drugs. The percentage of participants data was rounded to one decimal place. SFU: Safety Follow-Up.
Measured: From Baseline (Day 1) to the End of Safety Follow-Up (up to 116 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start4 Dec 2024
- Primary completion12 Jun 2025
- Study completion12 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy Study ParticipantsStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- In this single arm study the participants will receive a single dose of the cocktail of probe drugs at the first pre-specified timepoint followed by a washout and repeated oral doses of ZX008 and a single dose of the cocktail of probe drugs at the second pre-specified time point.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB BIOSCIENCES, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, 001 844 599 2273 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06679413
- Sponsor's protocol ID
- UP0132
- Status last verified
- Mar 2026
- First submitted
- 5 Nov 2024
- Last updated
- 2 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Center, Repeat-Dose, Open-Label, Fixed-Sequence Drug-Drug Interaction Study of ZX008 in Healthy Male Or Female Study Participants 18 To 55 Years Of Age
- ClinicalTrials.gov ID
- NCT06679413
- Acronym / sponsor ID
- UP0132
- Conditions
- Healthy Study Participants
- Keywords
- Healthy Study Participants, fenfluramine HCl, Drug-drug interaction, Phase 1, ZX008
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- UCB BIOSCIENCES, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- 12 Jun 2025 (actual)
- Study completion
- 12 Jun 2025 (actual)
- First posted
- 7 Nov 2024 (actual)
- Results
- Posted 2 Jul 2026
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 the study is to assess the single-dose pharmacokinetics (PK) of 3 probe drugs (midazolam, bupropion, and metformin) before and after repeat doses of ZX008
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In this single arm study the participants will receive a single dose of the cocktail of probe drugs at the first pre-specified timepoint followed by a washout and repeated oral doses of ZX008 and a single dose of the cocktail of probe drugs at the second pre-specified time point.
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: midazolam, Drug: metformin, Drug: bupropion, Drug: fenfluramine HClStudy participants will receive a single dose of the cocktail of probe drugs at pre-specified timepoints followed by a wash out period. The same study participants will then receive repeated oral doses of fenfluramine HCl (ZX008) and a single dose of the cocktail of probe drugs at pre-specified time points during this Treatment Period. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participant must be 18 to 55 years of age inclusive at the time of signing the informed consent form (ICF)
- Body weight of at least 50 kg and body mass index within the range 18 to 32 kg/m^2 (inclusive)
- Male or female
- Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Key exclusion criteria (23 listed)
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) above 1.1x upper limit of normal (ULN)
- Bilirubin >ULN (isolated bilirubin <1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
- Participant has clinically significant current or past history of cardiovascular or cerebrovascular disease, such as valvular heart disease, and/or pulmonary hypertension. Participants with any history of stroke or myocardial infarction are excluded.
- Clinically significant history or presence of electrocardiogram (ECG) or echocardiogram (ECHO) findings as judged by the investigator or designee at the Screening Visit and Check-in, including each criterion listed below:
- Abnormal sinus rhythm (heart rate outside of 40bpm and 100bpm)
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 |
|---|---|---|
| midazolamStudy participants will receive a pre specified single oral dose of probe drug midazolam on Day 1 and Day 22 of the study | Drug | Treatment Arm |
| metforminStudy participants will receive a pre-specified single oral dose of probe drug metformin on Day 1 and Day 22 of the study | Drug | Treatment Arm |
| bupropionStudy participants will receive a pre-specified single oral dose of probe drug bupropion on Day 1 and Day 22 of the study | Drug | Treatment Arm |
| fenfluramine HClAlso: Fintepla, ZX0008Study participants will receive pre-specified repeated oral doses of fenfluramine HCl (ZX008) from Day 6 to 26 during the study | Drug | Treatment Arm |
Primary outcome
Maximum Concentration (Cmax) of Midazolam Alone and in Combination With ZX008 at Steady State
Time frame: Day 1 (Treatment Period 1) and Day 22 (Treatment Period 2): Predose, 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 10,12, 24, 36, 48, 72, and 96 hours Postdose
Cmax is the maximum observed plasma concentration of Midazolam alone and in combination with ZX008 at steady state.
Maximum Concentration (Cmax) of Metformin Alone and in Combination With ZX008 at Steady State
Time frame: Day 1 (Treatment Period 1) and Day 22 (Treatment Period 2): Predose, 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 10,12, 24, 36, 48, 72, and 96 hours Postdose
Cmax is the maximum observed plasma concentration of Metformin alone and in combination with ZX008 at steady state.
Maximum Concentration (Cmax) of Bupropion Alone and in Combination With ZX008 at Steady State
Time frame: Day 1 (Treatment Period 1) and Day 22 (Treatment Period 2): Predose, 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 10,12, 24, 36, 48, 72, and 96 hours Postdose
Cmax is the maximum observed plasma concentration of Bupropion alone and in combination with ZX008 at steady state.
Area Under the Curve From 0 to Infinity (AUC) of Midazolam Alone and in Combination With ZX008 at Steady State
Time frame: Day 1 (Treatment Period 1) and Day 22 (Treatment Period 2): Predose, 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 10,12, 24, 36, 48, 72, and 96 hours Postdose
AUC is area under the plasma concentration-time curve from time 0 to infinity of Midazolam alone and in combination with ZX008 at steady state.
Area Under the Curve From 0 to Infinity (AUC) of Metformin Alone and in Combination With ZX008 at Steady State
Time frame: Day 1 (Treatment Period 1) and Day 22 (Treatment Period 2): Predose, 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 10,12, 24, 36, 48, 72, and 96 hours Postdose
AUC is area under the plasma concentration-time curve from time 0 to infinity of Metformin alone and in combination with ZX008 at steady state.
Area Under the Curve From 0 to Infinity (AUC) of Bupropion Alone and in Combination With ZX008 at Steady State
Time frame: Day 1 (Treatment Period 1) and Day 22 (Treatment Period 2): Predose, 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 10,12, 24, 36, 48, 72, and 96 hours Postdose
AUC is area under the plasma concentration-time curve from time 0 to infinity of Bupropion alone and in combination with ZX008 at steady state.
Area Under the Curve From 0 to the Time of the Last Quantifiable Concentration AUC(0-t) of Midazolam Alone and in Combination With ZX008 at Steady State
Time frame: Day 1 (Treatment Period 1) and Day 22 (Treatment Period 2): Predose, 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 10,12, 24, 36, 48, 72, and 96 hours Postdose
AUC(0-t) is area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration of Midazolam alone and in combination with ZX008 at steady state.
Area Under the Curve From 0 to the Time of the Last Quantifiable Concentration AUC(0-t) of Metformin Alone and in Combination With ZX008 at Steady State
Time frame: Day 1 (Treatment Period 1) and Day 22 (Treatment Period 2): Predose, 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 10,12, 24, 36, 48, 72, and 96 hours Postdose
AUC(0-t) is area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration of Metformin alone and in combination with ZX008 at steady state.
Area Under the Curve From 0 to the Time of the Last Quantifiable Concentration AUC(0-t) of Bupropion Alone and in Combination With ZX008 at Steady State
Time frame: Day 1 (Treatment Period 1) and Day 22 (Treatment Period 2): Predose, 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 10,12, 24, 36, 48, 72, and 96 hours Postdose
AUC(0-t) is area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration of Bupropion alone and in combination with ZX008 at steady state.
1 secondary outcome
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: From Baseline (Day 1) to the End of Safety Follow-Up (up to 116 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot 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.
UCB Cares study director
001 844 599 2273 (UCB)
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 midazolam, metformin and bupropion in people with Healthy Study Participants, run by UCB BIOSCIENCES, Inc. 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 23 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 2 Jul 2026. 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?
Yes. Results are posted in the registry (first posted 2 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maximum Concentration (Cmax) of Midazolam Alone and in Combination With ZX008 at Steady State (time frame: Day 1 (Treatment Period 1) and Day 22 (Treatment Period 2): Predose, 0.25, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 10,12, 24, 36, 48, 72, and 96 hours Postdose). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.