Healthy Adult ParticipantsPhase 1NCT07235748

Drug-drug Interaction Study of Vorasidenib With Bupropion, Repaglinide, Flurbiprofen, Omeprazole, Midazolam, and Rosuvastatin in Healthy Adult Participants

A Phase 1 study testing Vorasidenib, Bupropion and Flurbiprofen in people with Healthy Adult Participants, run by Institut de Recherches Internationales Servier (I.R.I.S.) at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Adult Participants
What is being tested?: Vorasidenib, Bupropion and Flurbiprofen
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteUnited Kingdom
Study dates: 7 Oct 2025to 23 Dec 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

Healthy male or non-pregnant, non-lactating female participants, including women of childbearing potential (WOCBP).
Body mass index (BMI) of 18.0 - 30.0 kg/m² (both inclusive), at Screening.
Body weight of at least 40 kg, at Screening.
Female participants of childbearing potential must use 2 effective methods of birth control, or abstinence from Screening until at least 90 days after the last dose of vorasidenib; be surgically sterile at least 6 months prior to the first dose of investigational medicinal product (IMP) in the study; or be postmenopausal. Female participants of childbearing potential must have a negative serum pregnancy test at Screening and prior to the first dose of IMP in the study.
Male participants with female partners of childbearing potential must be sterile, be willing to use 2 effective methods of birth control from Screening until at least 90 days after the last dose of vorasidenib, or practice abstinence from Screening until at least 90 days after the last dose of vorasidenib. Abstinence is acceptable only as true abstinence when this is in line with the preferred and usual lifestyle of the participant. Male participants should also agree to not donate sperm for the duration of the study and until at least 90 days after the last dose of vorasidenib.
The participant is a continuous nonsmoker who has not used nicotine-containing products (e.g., snuff, nicotine patch, nicotine chewing gum, mock cigarettes, or inhalers) for at least 3 months prior to the first dose of IMP in the study based on a cotinine test result.
The participant is considered by the investigator (or designee, if applicable) to be in good general health as determined by medical history, full physical examination, clinical laboratory test results, 12-lead electrocardiogram (ECG) results, and vital sign measurements findings at screening and admission.

Who cannot join

The participant is a WOCBP who is pregnant, lactating, or planning to become pregnant within at least 90 days after the last dose of vorasidenib in the study; the participant is on oral contraceptive pills or contraceptive patch within 14 days or 5 half-lives (whichever is longer) prior to the first dose of IMP in the study; the participant used a hormonal IUD or vaginal ring within 3 months prior to the first dose of IMP in the study; or the participant received any injectable or implantable hormone-containing product within 1 year prior to the first dose of IMP in the study.
The participant has consumed grapefruit or grapefruit juice or Seville orange or Seville orange-containing products (e.g., marmalade) within 14 days prior to the first dose of IMP in the study.
The participant has ingested vegetables from the mustard green family (e.g., kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, and mustard) and charbroiled meats within 14 days prior to the first dose of IMP in the study.
The participant has consumed caffeine- or xanthine-containing products (e.g., coffee, tea, cola drinks, and chocolate), alcohol, or products containing any of these within 48 hours prior to the first dose of IMP in the study.
The participant is unable or unwilling to abstain from recreational drugs, alcohol, caffeine, xanthine-containing beverages or food (e.g., coffee, tea, chocolate, and caffeinated sodas, colas), grapefruit, grapefruit juice, Seville oranges, or products containing any of these, from 48 hours (caffeine, xanthine-containing beverages or food, alcohol) or 14 days (recreational drugs, grapefruit, grapefruit juice, Seville oranges, or Seville orange-containing products) prior to the first dose of IMP in the study until the Discharge/Early Termination visit.
The participant has received any vaccine or used any prescription (including hormonal birth control or hormone replacement therapy) or over-the-counter medications (except acetaminophen/paracetamol [up to 2 g per 24 hours] or ibuprofen [up to 1.2 g per 24 hours]), including herbal (e.g., St. John's Wort) or nutritional supplements, within 14 days or 5 drug half-lives, whichever is longer, prior to the first dose of IMP in the study.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Celerion
Belfast, BT9 6AD

Other trials in United Kingdom

About this study

Official title: A Phase 1, Open-label, Single-sequence, 2-period Study to Evaluate the Effect of Multiple Doses of Vorasidenib on the Pharmacokinetics of a Single Dose of Sensitive Index Substrates of Cytochrome P450 2B6, 2C8, 2C9, 2C19, 3A4, and Breast Cancer Resistance Protein in Healthy Adult Participants

The objective of this study is to evaluate the effect of multiple doses of vorasidenib on single-dose PK of bupropion as an index substrate of CYP2B6, flurbiprofen as an index substrate of CYP2C9, omeprazole as an index substrate of CYP2C19, repaglinide as an index substrate of CYP2C8, midazolam as an index substrate of CYP3A4, and rosuvastatin as a substrate of BCRP in healthy adult participants. The study consists of screening, two treatment periods in-house, and a follow-up period. During the first period, Day 1 through Day 7, participants will receive CYPs and BCRP index substrates alone and during the second treatment period, Day 8 through Day 28, these will be administered in combination with vorasidenib. Participation in the study will be up to 87 days from screening through the follow up period.

Study activities may include blood tests, ECG, vital signs, and a physical examination.

Conditions: Healthy Adult Participants
Being tested: Vorasidenib, Bupropion, Flurbiprofen, Omeprazole, Midazolam

What participants receive

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

VorasidenibDrug
40mg taken orally daily from Day 8 through Day 28
BupropionDrug
150mg taken orally on Day 2 and Day 23
FlurbiprofenDrug
50mg taken orally on Day 1 and Day 22
OmeprazoleDrug
20mg taken orally on Day 1 and Day 22
MidazolamDrug
2mg taken orally on Day 1 and Day 22
RepaglinideDrug
0.5mg taken orally on Day 1 and Day 22
RosuvastatinDrug
10mg taken orally on Day 5 and Day 26

Study groups in NCT07235748
Study group	Role	What they receive
Vorasidenib and cytochrome P450 and transporter index substrates	Experimental	Participants will receive a single oral dose of 50mg flurbiprofen, 20mg omeprazole, 2mg midazolam and 0.5mg repaglinide on Day 1, 150mg bupropion on Day 2, and 10mg rosuvastatin on Day 5. Participants will receive an oral daily dose of 40mg vorasidenib from Day 8 to Day 28. In addition, participants will receive a single oral dose of 50mg flurbiprofen, 20mg omeprazole, 2mg midazolam and 0.5mg repaglinide on Day 22, 150mg bupropion on Day 23, and 10mg rosuvastatin on Day 26, co-administered with vorasidenib. Receives: Drug: Vorasidenib; Drug: Bupropion; Drug: Flurbiprofen; Drug: Omeprazole; Drug: Midazolam; Drug: Repaglinide; Drug: Rosuvastatin

What is being measured

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

Maximum concentration (Cmax) of bupropion and its metabolite hydroxybupropion, repaglinide, flurbiprofen, omeprazole, midazolam, and rosuvastatin
Measured: Through Day 29
Area under the plasma concentration versus time curve from time 0 to the last quantifiable concentration (AUC0-last) of bupropion and its metabolite hydroxybupropion, repaglinide, flurbiprofen, omeprazole, midazolam, and rosuvastatin
Measured: Through Day 29
Area under the plasma concentration versus time curve from 0 extrapolated to infinity (AUC0-inf) of bupropion and its metabolite hydroxybupropion, repaglinide, flurbiprofen, omeprazole, midazolam, and rosuvastatin
Measured: Through Day 29
Time corresponding to Cmax (Tmax) of bupropion and its metabolite hydroxybupropion, repaglinide, flurbiprofen, omeprazole, midazolam, and rosuvastatin
Measured: Through Day 29
Terminal half-life (t1/2) of bupropion and its metabolite hydroxybupropion, repaglinide, flurbiprofen, omeprazole, midazolam, and rosuvastatin
Measured: Through Day 29
Apparent oral clearance (CL/F) of bupropion and its metabolite hydroxybupropion, repaglinide, flurbiprofen, omeprazole, midazolam, and rosuvastatin
Measured: Through Day 29
Apparent volume of distribution during the terminal phase following oral administration (Vz/F) of bupropion and its metabolite hydroxybupropion, repaglinide, flurbiprofen, omeprazole, midazolam, and rosuvastatin
Measured: Through Day 29
Elimination rate constant (Kel) of bupropion and its metabolite hydroxybupropion, repaglinide, flurbiprofen, omeprazole, midazolam, and rosuvastatin
Measured: Through Day 29

Secondary outcomes (2)

Number of Adverse Events (AEs)
Measured: Through the Follow-up Phone Call (Day 57)
Trough plasma concentration (Ctrough) of vorasidenib
Measured: Through Day 29

Timeline

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

7 Oct 202523 Dec 2025

First posted19 Nov 2025
Study start7 Oct 2025
Primary completion23 Dec 2025
Study completion23 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy Adult 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
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07235748
Sponsor's protocol ID: S095032-230
Status last verified: Feb 2026
First submitted: 14 Nov 2025
Last updated: 17 Feb 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data. Access can be requested for all interventional clinical studies: * used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: * sponsored by Servier * with a first patient enrolled as of 1 January 2004 onwards * for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-label, Single-sequence, 2-period Study to Evaluate the Effect of Multiple Doses of Vorasidenib on the Pharmacokinetics of a Single Dose of Sensitive Index Substrates of Cytochrome P450 2B6, 2C8, 2C9, 2C19, 3A4, and Breast Cancer Resistance Protein in Healthy Adult Participants
ClinicalTrials.gov ID: NCT07235748
Acronym / sponsor ID: S095032-230
Conditions: Healthy Adult Participants
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Institut de Recherches Internationales Servier (I.R.I.S.)Industry (pharma, biotech, devices)
Study start: 7 Oct 2025 (actual)
Primary completion: 23 Dec 2025 (actual)
Study completion: 23 Dec 2025 (actual)
First posted: 19 Nov 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.

Study activities may include blood tests, ECG, vital signs, and a physical examination.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Vorasidenib and cytochrome P450 and transporter index substrates	Experimental	Drug: Vorasidenib, Drug: Bupropion, Drug: Flurbiprofen, Drug: Omeprazole, Drug: Midazolam, Drug: Repaglinide, Drug: RosuvastatinParticipants will receive a single oral dose of 50mg flurbiprofen, 20mg omeprazole, 2mg midazolam and 0.5mg repaglinide on Day 1, 150mg bupropion on Day 2, and 10mg rosuvastatin on Day 5. Participants will receive an oral daily dose of 40mg vorasidenib from Day 8 to Day 28. In addition, participants will receive a single oral dose of 50mg flurbiprofen, 20mg omeprazole, 2mg midazolam and 0.5mg repaglinide on Day 22, 150mg bupropion on Day 23, and 10mg rosuvastatin on Day 26, co-administered with vorasidenib.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Healthy male or non-pregnant, non-lactating female participants, including women of childbearing potential (WOCBP).
Body mass index (BMI) of 18.0 - 30.0 kg/m² (both inclusive), at Screening.
Body weight of at least 40 kg, at Screening.
Female participants of childbearing potential must use 2 effective methods of birth control, or abstinence from Screening until at least 90 days after the last dose of vorasidenib; be surgically sterile at least 6 months prior to the first dose of investigational medicinal product (IMP) in the study; or be postmenopausal. Female participants of childbearing potential must have a negative serum pregnancy test at Screening and prior to the first dose of IMP in the study.
Male participants with female partners of childbearing potential must be sterile, be willing to use 2 effective methods of birth control from Screening until at least 90 days after the last dose of vorasidenib, or practice abstinence from Screening until at least 90 days after the last dose of vorasidenib. Abstinence is acceptable only as true abstinence when this is in line with the preferred and usual lifestyle of the participant. Male participants should also agree to not donate sperm for the duration of the study and until at least 90 days after the last dose of vorasidenib.

Key exclusion criteria (6 listed)

The participant is a WOCBP who is pregnant, lactating, or planning to become pregnant within at least 90 days after the last dose of vorasidenib in the study; the participant is on oral contraceptive pills or contraceptive patch within 14 days or 5 half-lives (whichever is longer) prior to the first dose of IMP in the study; the participant used a hormonal IUD or vaginal ring within 3 months prior to the first dose of IMP in the study; or the participant received any injectable or implantable hormone-containing product within 1 year prior to the first dose of IMP in the study.
The participant has consumed grapefruit or grapefruit juice or Seville orange or Seville orange-containing products (e.g., marmalade) within 14 days prior to the first dose of IMP in the study.
The participant has ingested vegetables from the mustard green family (e.g., kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, and mustard) and charbroiled meats within 14 days prior to the first dose of IMP in the study.
The participant has consumed caffeine- or xanthine-containing products (e.g., coffee, tea, cola drinks, and chocolate), alcohol, or products containing any of these within 48 hours prior to the first dose of IMP in the study.
The participant is unable or unwilling to abstain from recreational drugs, alcohol, caffeine, xanthine-containing beverages or food (e.g., coffee, tea, chocolate, and caffeinated sodas, colas), grapefruit, grapefruit juice, Seville oranges, or products containing any of these, from 48 hours (caffeine, xanthine-containing beverages or food, alcohol) or 14 days (recreational drugs, grapefruit, grapefruit juice, Seville oranges, or Seville orange-containing products) prior to the first dose of IMP in the study until the Discharge/Early Termination visit.

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
Vorasidenib40mg taken orally daily from Day 8 through Day 28	Drug	Vorasidenib and cytochrome P450 and transporter index substrates
Bupropion150mg taken orally on Day 2 and Day 23	Drug	Vorasidenib and cytochrome P450 and transporter index substrates
Flurbiprofen50mg taken orally on Day 1 and Day 22	Drug	Vorasidenib and cytochrome P450 and transporter index substrates
Omeprazole20mg taken orally on Day 1 and Day 22	Drug	Vorasidenib and cytochrome P450 and transporter index substrates
Midazolam2mg taken orally on Day 1 and Day 22	Drug	Vorasidenib and cytochrome P450 and transporter index substrates
Repaglinide0.5mg taken orally on Day 1 and Day 22	Drug	Vorasidenib and cytochrome P450 and transporter index substrates
Rosuvastatin10mg taken orally on Day 5 and Day 26	Drug	Vorasidenib and cytochrome P450 and transporter index substrates

Primary outcome

Maximum concentration (Cmax) of bupropion and its metabolite hydroxybupropion, repaglinide, flurbiprofen, omeprazole, midazolam, and rosuvastatin
Time frame: Through Day 29
Area under the plasma concentration versus time curve from time 0 to the last quantifiable concentration (AUC0-last) of bupropion and its metabolite hydroxybupropion, repaglinide, flurbiprofen, omeprazole, midazolam, and rosuvastatin
Time frame: Through Day 29
Area under the plasma concentration versus time curve from 0 extrapolated to infinity (AUC0-inf) of bupropion and its metabolite hydroxybupropion, repaglinide, flurbiprofen, omeprazole, midazolam, and rosuvastatin
Time frame: Through Day 29
Time corresponding to Cmax (Tmax) of bupropion and its metabolite hydroxybupropion, repaglinide, flurbiprofen, omeprazole, midazolam, and rosuvastatin
Time frame: Through Day 29
Terminal half-life (t1/2) of bupropion and its metabolite hydroxybupropion, repaglinide, flurbiprofen, omeprazole, midazolam, and rosuvastatin
Time frame: Through Day 29
Apparent oral clearance (CL/F) of bupropion and its metabolite hydroxybupropion, repaglinide, flurbiprofen, omeprazole, midazolam, and rosuvastatin
Time frame: Through Day 29
Apparent volume of distribution during the terminal phase following oral administration (Vz/F) of bupropion and its metabolite hydroxybupropion, repaglinide, flurbiprofen, omeprazole, midazolam, and rosuvastatin
Time frame: Through Day 29
Elimination rate constant (Kel) of bupropion and its metabolite hydroxybupropion, repaglinide, flurbiprofen, omeprazole, midazolam, and rosuvastatin
Time frame: Through Day 29

2 secondary outcomes

Number of Adverse Events (AEs)
Time frame: Through the Follow-up Phone Call (Day 57)
Trough plasma concentration (Ctrough) of vorasidenib
Time frame: Through Day 29

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 17 Feb 2026.
Individual participant dataSharing planned: Yes. Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data. Access can be requested for all interventional clinical studies: * used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: * sponsored by Servier * with a first patient enrolled as of 1 January 2004 onwards * for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval

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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?

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 7 inclusion and 6 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 17 Feb 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 Kingdom. 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?

Maximum concentration (Cmax) of bupropion and its metabolite hydroxybupropion, repaglinide, flurbiprofen, omeprazole, midazolam, and rosuvastatin (time frame: Through Day 29). The study lists 8 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 NCT07235748.

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 17 Feb 2026.