A Study to Assess Drug-drug Interaction of ZX008 in Healthy Male and Female Study Participants

June 5, 2026 updated by: UCB BIOSCIENCES, Inc.

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: UCB Cares
  • Phone Number: 001 844 599 2273

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21225
        • Up0132 1001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment Arm
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.
Drug: midazolam
Study participants will receive a pre specified single oral dose of probe drug midazolam on Day 1 and Day 22 of the study
Drug: metformin
Study participants will receive a pre-specified single oral dose of probe drug metformin on Day 1 and Day 22 of the study
Drug: bupropion
Study participants will receive a pre-specified single oral dose of probe drug bupropion on Day 1 and Day 22 of the study
Drug: fenfluramine HCl
Study participants will receive pre-specified repeated oral doses of fenfluramine HCl (ZX008) from Day 6 to 26 during the study
Other Names:
  • Fintepla
  • ZX0008

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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.
From Baseline (Day 1) to the End of Safety Follow-Up (up to 116 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
UCB BIOSCIENCES, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: UCB Cares, 001 844 599 2273 (UCB)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 4, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 12, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 12, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UP0132

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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