Healthy Adult Female ParticipantsPhase 1NCT07235774
A Drug-drug Interaction Study of Vorasidenib and a Combined Oral Contraceptive in Healthy Female Participants
A Phase 1 study testing Vorasidenib and DRSP/EE in people with Healthy Adult Female Participants, run by Institut de Recherches Internationales Servier (I.R.I.S.) at 1 site in United Kingdom.
Trial summary
The objective of this study is to evaluate the effect of multiple oral doses of vorasidenib on the single dose pharmacokinetics of the representative combined oral contraceptive, drospirenone (DRSP)/ethinyl estradiol (EE), in healthy female participants. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Female Participants
- What is being tested?
- Vorasidenib and DRSP/EE
- 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
- 5 Nov 2025to 13 Mar 2026
- 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, nonpregnant, nonlactating pre- or post-menopausal female participants, including women of childbearing potential (WOCBP), assigned female at birth only.
- 18 - 55 years of age (both inclusive) at Screening.
- Body mass index (BMI) of 18.0 - 30.0 kg/m² (both inclusive) at Screening.
- Body weight of at least 40 kg at Screening.
- Participants of childbearing potential who must use two effective methods of birth control (e.g., non-hormonal intrauterine device [IUD], male or female condom with spermicide, cap, diaphragm, or sponge with spermicide), or abstinence, from Screening until at least 90 days after the last dose of vorasidenib or who must be surgically sterile (e.g., hysteroscopic sterilization, bilateral tubal salpingectomy, hysterectomy, or bilateral oophorectomy) at least 6 months prior to the first dose of IMP in the study. Participants of childbearing potential must have a negative serum pregnancy test at Screening and prior to the first dose of IMP in the study.
- Post-menopausal participants (defined as amenorrhea for 12 consecutive months and documented plasma follicle stimulating hormone [FSH] level > 40 IU/mL) who must have a FSH test confirming the post-menopausal status at Screening.
- 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.
- Participants who are considered by the Investigator 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
- Participants of childbearing potential who are pregnant, lactating, or planning to become pregnant within at least 90 days after the last dose of vorasidenib; the participants who are on oral contraceptive pills or contraceptive patch within 31 days prior to the first dose of IMP in the study; participants who use a hormonal IUD or vaginal ring within 3 months prior to the first dose of IMP in the study; or participants who receive any injectable or implantable hormone containing product within 1 year prior to the first dose of IMP in the study.
- Participant who consume 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.
- Participant who ingest 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.
- Participant who consume 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.
- Participants who are 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.
- In the opinion of the Investigator, participants who are not suitable for entry into the study.
- Participant who have received any vaccine or used any prescription (including 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.
About this study
Official title: A Phase 1, Open-label, Single-sequence, 2-period Study to Determine the Effects of Repeated Oral Dosing of Vorasidenib on the Pharmacokinetics, Safety and Tolerability of a Combined Oral Contraceptive in Healthy Female Participants.
The objective of this study is to evaluate the effect of multiple oral doses of vorasidenib on the single dose pharmacokinetics of the representative combined oral contraceptive, drospirenone (DRSP)/ethinyl estradiol (EE), in healthy female participants. The study includes a screening phase, two treatment periods in-house, and a follow-up period. During the first period, from Day 1 through Day 5, participants will take one dose of DRSP/EE. In the second treatment period, from Day 6 through Day 24, participants will take vorasidenib every day, and on Day 20, they will take DRSP/EE along with vorasidenib. The entire study, including screening and follow-up, will last up to 83 days. Participants may undergo blood tests, heart tests (electrocardiogram (ECG)), vital sign checks, and physical exams.
- Conditions
- Healthy Adult Female Participants
- Being tested
- Vorasidenib, DRSP/EE
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 6 through Day 24
DRSP/EEDrug
3 mg DRSP/0.02 mg EE taken orally on Day 1 and Day 20
| Study group | Role | What they receive |
|---|---|---|
| Vorasidenib and drospirenone (DRSP)/ethinyl estradiol (EE) | Experimental | Participants will receive a single oral dose of 3 mg DRSP/0.02 mg EE on Day 1.
Participants will receive an oral daily dose of 40mg vorasidenib from Day 6 to Day 24. In addition, participants will receive a single oral dose of 3 mg DRSP/0.02 mg EE on Day 20, co-administered with vorasidenib. Receives: Drug: Vorasidenib; Drug: DRSP/EE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum concentration (Cmax) of DRSP and EE
Measured: Through Day 25
Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-last) of DRSP and EE
Measured: Through Day 25
AUC from 0 extrapolated to infinity (AUC0-inf) of DRSP and EE
Measured: Through Day 25
Time corresponding to Cmax (Tmax) of DRSP and EE
Measured: Through Day 25
Terminal half-life (t1/2) of DRSP and EE
Measured: Through Day 25
Apparent oral clearance (CL/F) of DRSP and EE
Measured: Through Day 25
Apparent volume of distribution during the terminal phase following oral administration (Vz/F) of DRSP and EE
Measured: Through Day 25
Elimination rate constant (Kel) of DRSP and EE
Measured: Through Day 25
Secondary outcomes (2)
Number of Adverse Events (AEs)
Measured: Through the Follow-up Phone Call (Day 53)
Trough plasma concentration (Ctrough) of vorasidenib
Measured: Through Day 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start5 Nov 2025
- Primary completion13 Mar 2026
- Study completion13 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult Female 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)
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Internationales Servier (I.R.I.S.)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07235774
- Sponsor's protocol ID
- S095032-234
- Status last verified
- May 2026
- First submitted
- 14 Nov 2025
- Last updated
- 12 May 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 May 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 Determine the Effects of Repeated Oral Dosing of Vorasidenib on the Pharmacokinetics, Safety and Tolerability of a Combined Oral Contraceptive in Healthy Female Participants.
- ClinicalTrials.gov ID
- NCT07235774
- Acronym / sponsor ID
- S095032-234
- Conditions
- Healthy Adult Female 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
- 5 Nov 2025 (actual)
- Primary completion
- 13 Mar 2026 (actual)
- Study completion
- 13 Mar 2026 (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.
The objective of this study is to evaluate the effect of multiple oral doses of vorasidenib on the single dose pharmacokinetics of the representative combined oral contraceptive, drospirenone (DRSP)/ethinyl estradiol (EE), in healthy female participants. The study includes a screening phase, two treatment periods in-house, and a follow-up period. During the first period, from Day 1 through Day 5, participants will take one dose of DRSP/EE. In the second treatment period, from Day 6 through Day 24, participants will take vorasidenib every day, and on Day 20, they will take DRSP/EE along with vorasidenib. The entire study, including screening and follow-up, will last up to 83 days. Participants may undergo blood tests, heart tests (electrocardiogram (ECG)), vital sign checks, and physical exams.
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 drospirenone (DRSP)/ethinyl estradiol (EE) | Experimental | Drug: Vorasidenib, Drug: DRSP/EEParticipants will receive a single oral dose of 3 mg DRSP/0.02 mg EE on Day 1. Participants will receive an oral daily dose of 40mg vorasidenib from Day 6 to Day 24. In addition, participants will receive a single oral dose of 3 mg DRSP/0.02 mg EE on Day 20, co-administered with vorasidenib. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy, nonpregnant, nonlactating pre- or post-menopausal female participants, including women of childbearing potential (WOCBP), assigned female at birth only.
- 18 - 55 years of age (both inclusive) at Screening.
- Body mass index (BMI) of 18.0 - 30.0 kg/m² (both inclusive) at Screening.
- Body weight of at least 40 kg at Screening.
- Participants of childbearing potential who must use two effective methods of birth control (e.g., non-hormonal intrauterine device [IUD], male or female condom with spermicide, cap, diaphragm, or sponge with spermicide), or abstinence, from Screening until at least 90 days after the last dose of vorasidenib or who must be surgically sterile (e.g., hysteroscopic sterilization, bilateral tubal salpingectomy, hysterectomy, or bilateral oophorectomy) at least 6 months prior to the first dose of IMP in the study. Participants of childbearing potential must have a negative serum pregnancy test at Screening and prior to the first dose of IMP in the study.
Key exclusion criteria (7 listed)
- Participants of childbearing potential who are pregnant, lactating, or planning to become pregnant within at least 90 days after the last dose of vorasidenib; the participants who are on oral contraceptive pills or contraceptive patch within 31 days prior to the first dose of IMP in the study; participants who use a hormonal IUD or vaginal ring within 3 months prior to the first dose of IMP in the study; or participants who receive any injectable or implantable hormone containing product within 1 year prior to the first dose of IMP in the study.
- Participant who consume 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.
- Participant who ingest 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.
- Participant who consume 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.
- Participants who are 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 6 through Day 24 | Drug | Vorasidenib and drospirenone (DRSP)/ethinyl estradiol (EE) |
| DRSP/EE3 mg DRSP/0.02 mg EE taken orally on Day 1 and Day 20 | Drug | Vorasidenib and drospirenone (DRSP)/ethinyl estradiol (EE) |
Primary outcome
Maximum concentration (Cmax) of DRSP and EE
Time frame: Through Day 25
Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-last) of DRSP and EE
Time frame: Through Day 25
AUC from 0 extrapolated to infinity (AUC0-inf) of DRSP and EE
Time frame: Through Day 25
Time corresponding to Cmax (Tmax) of DRSP and EE
Time frame: Through Day 25
Terminal half-life (t1/2) of DRSP and EE
Time frame: Through Day 25
Apparent oral clearance (CL/F) of DRSP and EE
Time frame: Through Day 25
Apparent volume of distribution during the terminal phase following oral administration (Vz/F) of DRSP and EE
Time frame: Through Day 25
Elimination rate constant (Kel) of DRSP and EE
Time frame: Through Day 25
2 secondary outcomes
Number of Adverse Events (AEs)
Time frame: Through the Follow-up Phone Call (Day 53)
Trough plasma concentration (Ctrough) of vorasidenib
Time frame: Through Day 24
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 12 May 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?
A Phase 1 study testing Vorasidenib and DRSP/EE in people with Healthy Adult Female Participants, run by Institut de Recherches Internationales Servier (I.R.I.S.) at 1 site in United Kingdom.
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 8 inclusion and 7 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 12 May 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 DRSP and EE (time frame: Through Day 25). 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?
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 12 May 2026.