Drug Drug InteractionPhase 1NCT06232109
Drug-Drug Interaction of ASN51 With Fluvoxamine, Itraconazole and Paroxetine in Healthy Subjects
A Phase 1 study testing Fluvoxamine, Itraconazole and Paroxetine in people with Drug Drug Interaction, run by Asceneuron S.A. at 1 site in Netherlands.
Trial summary
The drug-drug interaction study has been designed to investigate the effect of Fluvoxamine, Itraconazole and Paroxetine on the pharmacokinetics of ASN51 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Drug Interaction
- What is being tested?
- Fluvoxamine, Itraconazole and Paroxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Feb 2024to 3 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males or females of nonchildbearing potential
- Aged 18-55 years (inclusive) at time of Screening
- Deemed healthy based on medical history, physical and neurological examination, electrocardiogram (ECG), vital signs, and laboratory tests of blood and urine
- Body weight ≥ 50.0 kg (men) or ≥ 45.0 kg (women) at Screening
- Body mass index (BMI); Quetelet index in the range 18.0-30.9 kg/m2 (inclusive) at Screening
Who cannot join
- Clinically relevant abnormal medical history, physical or neurological findings, ECG, or laboratory values at Screening, or before the first dose of any study medication, that could interfere with the objectives of the study or the safety of the subject
- History or presence of acute or chronic illness, or clinically-significant medical abnormality, sufficient to invalidate the subject's participation in the study or make it unnecessarily hazardous
- History or presence of any disease, medical condition, or surgery (e.g., stomach bypass), likely to affect the absorption, distribution, metabolism, or excretion of medicines. Subjects with a history of cholecystectomy
- Presence or history of severe or clinically significant adverse reaction to any drug; or a history of sensitivity to ASN51 (all subjects), or any components of the medications
- Receipt of an investigational product or device within 6 weeks (or 5 half-lives, or twice the duration of the biological effect, of the investigational product, if known - whichever is longer) before the first dose of study medication; in the follow-up period of another clinical study at the time of Screening for this study
- Use of a prescription medicine during the 14 days (or 5 half-lives of the medicine, if known - whichever is longer) before the first dose of study medication
Show all 9Show fewer
- Use of an over-the-counter medicine, including vitamins, herbal, or dietary supplements (including St John's Wort), with the exception of acetaminophen (paracetamol), during the 7 days (or 5 half-lives of the medicine, if known - whichever is longer, or 28 days if the medicine is a potential hepatic enzyme inducer) before the first dose of study medication
- Positive test for hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
- Note: Other protocol defined Inclusion/Exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1, Open-Label, Parallel Group Drug-Drug Interaction Study to Assess the Effect of Fluvoxamine (CYP2C19 Inhibitor), Itraconazole (CYP3A4 Inhibitor) and Paroxetine (CYP2D6 Inhibitor) on the Pharmacokinetics of ASN51 in Healthy Subjects
The drug-drug interaction study has been designed to investigate the effect of Fluvoxamine, Itraconazole and Paroxetine on the pharmacokinetics of ASN51
- Conditions
- Drug Drug Interaction
- Being tested
- Fluvoxamine, Itraconazole, Paroxetine, ASN51
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluvoxamineDrug
Oral
ItraconazoleDrug
Oral
ParoxetineDrug
Oral
ASN51Drug
Oral
| Study group | Role | What they receive |
|---|---|---|
| ASN51 | No intervention | Not described |
| ASN51 + Fluvoxamine | Experimental | Not described Receives: Drug: Fluvoxamine; Drug: ASN51 |
| ASN51 + Itraconazole | Experimental | Not described Receives: Drug: Itraconazole; Drug: ASN51 |
| ASN51 + Paroxetine | Experimental | Not described Receives: Drug: Paroxetine; Drug: ASN51 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of ASN51
Measured: Up to Day 15
Tmax of ASN51
Measured: Up to Day 15
AUC0-tau of ASN51
Measured: Up to Day 15
AUC0-inf of ASN51
Measured: Up to Day 15
t1/2 of ASN51
Measured: Up to Day 15
λz of ASN51
Measured: Up to Day 15
Secondary outcomes (1)
Number of participants with adverse events
Measured: Up to Day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start22 Feb 2024
- Primary completion3 Jul 2024
- Study completion3 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Drug InteractionStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asceneuron S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rolf Pokorny, MD, Study chair, Asceneuron, SAJeroen v Wetering, MD, Principal investigator, QPS Holdings LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06232109
- Sponsor's protocol ID
- ASN51-104
- Status last verified
- Dec 2024
- First submitted
- 22 Jan 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Open-Label, Parallel Group Drug-Drug Interaction Study to Assess the Effect of Fluvoxamine (CYP2C19 Inhibitor), Itraconazole (CYP3A4 Inhibitor) and Paroxetine (CYP2D6 Inhibitor) on the Pharmacokinetics of ASN51 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06232109
- Acronym / sponsor ID
- ASN51-104
- Conditions
- Drug Drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Asceneuron S.A.Industry (pharma, biotech, devices)
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- 3 Jul 2024 (actual)
- Study completion
- 3 Jul 2024 (actual)
- First posted
- 30 Jan 2024 (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 drug-drug interaction study has been designed to investigate the effect of Fluvoxamine, Itraconazole and Paroxetine on the pharmacokinetics of ASN51
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ASN51 | No intervention | – |
| ASN51 + Fluvoxamine | Experimental | Drug: Fluvoxamine, Drug: ASN51 |
| ASN51 + Itraconazole | Experimental | Drug: Itraconazole, Drug: ASN51 |
| ASN51 + Paroxetine | Experimental | Drug: Paroxetine, Drug: ASN51 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy males or females of nonchildbearing potential
- Aged 18-55 years (inclusive) at time of Screening
- Deemed healthy based on medical history, physical and neurological examination, electrocardiogram (ECG), vital signs, and laboratory tests of blood and urine
- Body weight ≥ 50.0 kg (men) or ≥ 45.0 kg (women) at Screening
- Body mass index (BMI); Quetelet index in the range 18.0-30.9 kg/m2 (inclusive) at Screening
Key exclusion criteria (9 listed)
- Clinically relevant abnormal medical history, physical or neurological findings, ECG, or laboratory values at Screening, or before the first dose of any study medication, that could interfere with the objectives of the study or the safety of the subject
- History or presence of acute or chronic illness, or clinically-significant medical abnormality, sufficient to invalidate the subject's participation in the study or make it unnecessarily hazardous
- History or presence of any disease, medical condition, or surgery (e.g., stomach bypass), likely to affect the absorption, distribution, metabolism, or excretion of medicines. Subjects with a history of cholecystectomy
- Presence or history of severe or clinically significant adverse reaction to any drug; or a history of sensitivity to ASN51 (all subjects), or any components of the medications
- Receipt of an investigational product or device within 6 weeks (or 5 half-lives, or twice the duration of the biological effect, of the investigational product, if known - whichever is longer) before the first dose of study medication; in the follow-up period of another clinical study at the time of Screening for this study
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 |
|---|---|---|
| FluvoxamineOral | Drug | ASN51 + Fluvoxamine |
| ItraconazoleOral | Drug | ASN51 + Itraconazole |
| ParoxetineOral | Drug | ASN51 + Paroxetine |
| ASN51Oral | Drug | ASN51 + Fluvoxamine, ASN51 + Itraconazole, ASN51 + Paroxetine |
Primary outcome
Cmax of ASN51
Time frame: Up to Day 15
Tmax of ASN51
Time frame: Up to Day 15
AUC0-tau of ASN51
Time frame: Up to Day 15
AUC0-inf of ASN51
Time frame: Up to Day 15
t1/2 of ASN51
Time frame: Up to Day 15
λz of ASN51
Time frame: Up to Day 15
1 secondary outcome
Number of participants with adverse events
Time frame: Up to Day 22
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 18 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Rolf Pokorny, MD study chair
Asceneuron, SA
Jeroen v Wetering, MD principal investigator
QPS Holdings LLC
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 Fluvoxamine, Itraconazole and Paroxetine in people with Drug Drug Interaction, run by Asceneuron S.A. at 1 site in Netherlands.
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 5 inclusion and 9 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 18 Dec 2024. 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 Netherlands. 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?
Cmax of ASN51 (time frame: Up to Day 15). The study lists 6 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 18 Dec 2024.