Healthy SubjectsPhase 1NCT05843708
A Phase 1, Open-Label Study to Evaluate the Effect of a Low-Fat Meal and Multiple Doses of Ciprofloxacin on the Pharmacokinetics of Vorasidenib in Healthy Subjects
A Phase 1 study testing Vorasidenib 40 mg Oral Tablet, Ciprofloxacin 500 mg Oral Tablet and Vorasidenib 10 mg Oral Tablet in people with Healthy Subjects, run by Servier Bio-Innovation LLC at 1 site in United States.
Trial summary
The objectives of this study are: To evaluate the effect of a low-fat meal on the pharmacokinetics (PK) of vorasidenib following a single oral dose of 40 mg vorasidenib in healthy adult subjects (substudy A) To evaluate the effect of multiple-dose ciprofloxacin (strong cytochrome P450 [CYP]1A2 inhibitor) on the… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Vorasidenib 40 mg Oral Tablet, Ciprofloxacin 500 mg Oral Tablet and Vorasidenib 10 mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2023to 28 Jul 2023
- 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
- The subject is male or non-pregnant, non-lactating female 18 to 55 years of age, inclusive.
- The subject has a body mass index 18 to 32 kg/m2, inclusive, at screening.
- The subject has normal hepatic function (aspartate transaminase [AST], alanine transaminase [ALT], total and direct bilirubin, international normalized ratio [INR] all ≤ upper limit of normal [ULN]).
- The subject has normal renal function as evidenced by creatinine clearance >90 mL/min based on the Cockcroft-Gault glomerular filtration rate estimation: (140 - Age) × (Weight in kg) × (0.85 if female) / (72 × serum creatinine).
- The subject is considered by the investigator to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead ECG results, and physical examination findings at screening and check-in.
- Female subjects of childbearing potential must use 2 effective methods of birth control (eg, diaphragm with spermicide, intrauterine device, condom with foam or vaginal spermicide) or abstinence [true abstinence when this is in line with the preferred and usual lifestyle of the subject]) during the study and for 90 days after the last dose of vorasidenib or be surgically sterile (eg, hysteroscopic sterilization, bilateral tubal ligation or bilateral salpingectomy, hysterectomy, or bilateral oophorectomy), or postmenopausal (defined as amenorrhea 12 consecutive months and documented plasma follicle-stimulating hormone level >40 IU/mL). Female subjects must have a negative pregnancy test at screening and before the first dose of study drug.
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- Male subjects with female partners of childbearing potential must be sterile or be willing to use 2 effective methods of birth control from screening until at least 90 days after the last dose of study drug, or practice abstinence during the study and for 90 days after the last dose of study drug. Abstinence is acceptable only as true abstinence when this is in line with the preferred and usual lifestyle of the subject. Male subjects should also agree to not donate sperm for the duration of the study and until at least 90 days after the last dose of study drug.
- The subject is a continuous nonsmoker who has not used nicotine-containing products (eg, snuff, nicotine patch, nicotine chewing gum, mock cigarettes, or inhalers) for at least 3 months prior to the first dose of study drug, based on cotinine test result.
- The subject agrees to comply with all protocol requirements for the duration of the study.
- The subject is able to provide written informed consent prior to any procedure required by the study.
Who cannot join
- The subject has a history or clinical manifestations of a significant neurological, renal, cardiovascular, gastrointestinal, hepatic, pulmonary, hematologic, immunologic, or psychiatric disease that would preclude study participation, as judged by the investigator.
- The subject has a history (within 5 years prior to screening) or presence of malignancy, except for adequately treated basal cell and squamous cell carcinoma of the skin.
- The subject has a history of severe and/or uncontrolled ventricular arrhythmias, or other factors that increase the risk of QT prolongation or arrhythmic events (eg, heart failure, hypomagnesemia, hypokalemia, family history of long QT interval syndrome) or the subject was taking medications that are known to prolong the QT interval unless they can be safely discontinued ≥30 days or 5 half-lives (whichever is longer) before dosing.
- The subject has any surgical or medical condition(s) possibly affecting drug absorption, distribution, metabolism, and excretion (eg, cholecystectomy, bariatric procedure). Subjects with appendectomy may be included.
- The subject is a woman of childbearing potential who is pregnant, lactating, or planning to become pregnant within 90 days after the last dose of study drug, or the subject is on oral contraceptive pills (moderate CYP1A2 inhibitors) within 14 days or 5 half-lives (whichever is longer) prior to the first dose administration and/or during the study.
- The subject has a positive test result for hepatitis B surface antigen or antibodies to hepatitis C virus (HCV) (if antibody test result is positive, it will be followed up with an HCV RNA test to confirm; those with undetectable HCV RNA will not be excluded).
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- The subject has a positive test result for human immunodeficiency virus (HIV) type 1 or 2 antibodies at screening.
- The subject has a positive test result for the presence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at check-in (Day -1). The subject has received the coronavirus disease 2019 (COVID-19) vaccine within 7 days prior to screening or plans to receive a COVID-19 vaccine within 7 days after receiving the study drug.
- The subject has used strong CYP1A2 inhibitors and/or inducers within 14 days or 5 half-lives, whichever is longer, prior to the first dose administration and during the study (with the exception of study-specified ciprofloxacin during the study for subjects on Substudy B).
- The subject has received any vaccine or used any prescription (including hormonal birth control) or over-the-counter medications (except acetaminophen/paracetamol [up to 2 g per day]), including herbal or nutritional supplements, within 30 days or 5 drug half-lives whichever is longer (for all vaccines/medications other than hormonal birth control), or within 14 days or 5 drug half-lives, whichever is longer (for hormonal birth control medications), before the first dose of study drug and throughout the study. Hormone replacement therapy will not be allowed.
- The subject has consumed grapefruit or grapefruit juice, Seville orange or Seville orange-containing products (eg, marmalade), or caffeine- or xanthine-containing products within 48 hours before the first dose of study drug.
- The subject has a history of symptomatic hypoglycemia or hypoglycemia requiring intervention.
- The subject has a history of alcoholism or drug abuse within 3 months before screening, or excessive alcohol consumption (regular alcohol intake >21 units per week for male subjects and >14 units of alcohol per week for female subjects) (1 unit is equal to approximately ½ pint [200 mL] of beer, 1 small glass [100 mL] of wine, or 1 measure [25 mL] of spirits).
- The subject has a positive test result for drugs of abuse, alcohol, or cotinine (indicating active current smoking) at screening or before the first dose of study drug.
- The subject is unable or unwilling to abstain from recreational drugs, alcohol, caffeine, xanthine-containing beverages or food (eg, coffee, tea, chocolate, and caffeinated sodas, colas), grapefruit, grapefruit juice, Seville oranges, or products containing any of these, from 48 hours prior to study drug dosing until EOS.
- The subject has been on a diet incompatible with the on-study diet, in the opinion of the Investigator or designee, within the 30 days prior to the first dosing and throughout the study.
- The subject is involved in strenuous activity (>30 min per day) or contact sports within 48 to 72 hours before dosing and during the study.
- The subject has excessive exposure to natural or artificial sunlight (tanning beds or UV A/B treatment) within 48 to 72 hours before dosing and during the study.
- The subject has donated blood or blood products >450 mL within 30 days before the first dose of study drug.
- The subject has a history of any hypersensitivity, allergy, or other contraindication to the components of the vorasidenib, ciprofloxacin, or activated charcoal formulations used in this study or any significant food allergy.
- The subject was exposed to an investigational drug (new chemical entity) within 30 days preceding the first dose administration, or 5 half-lives of that investigational drug, if known (whichever is longer).
- The subject is part of the clinical staff personnel or a family member of the clinical site staff.
- In the opinion of the investigator, the subject is not suitable for entry into the study.
- Additional Exclusion Criteria for Substudy B:
- The subject has hypersensitivity to any fluoroquinolone.
- The subject is at increased risk of Clostridium difficile (eg, prior history of C. difficile infection, recent use of systemic antibiotics [oral, intramuscular, or intravenous] in the last 6 months, recent abdominal surgery within 3 months prior to check-in, history of inflammatory bowel disease, or as judged by the investigator).
- The subject has had any medical condition that has required frequent or repeat course of antibiotics within the last 6 months. (eg recurrent urinary tract infection [UTI], strep pharyngitis, otitis media, or as judged by the investigator).
- The subject has any history of tendon rupture or known vascular abnormality.
- The subject is unable or unwilling to abstain from dairy products or mineral fortified drinks (eg, milk, yogurt, calcium-fortified orange juice) from 48 hours prior to study drug dosing until discharge.
- The subject has useD of glyburide, cyclosporine, didanosine, methotrexate, or probenecid within 30 days prior to Day 1 or within 5 half-lives of Day 1, whichever is longer.
- The subject is at high risk for QT prolongation, including:
- Baseline QTcF ≥ 450 msec
- Risk factors for Torsade de Pointes, including hypocalcemia, hypokalemia, hypomagnesemia, sudden death of unknown cause in a close family member (ie, biological mother, father, or siblings), a near drowning episode, a family history of long QT syndrome.
- The subject has any history of clinically significant photosensitivity, including, but not limited to a history of phototoxic and/or photoallergic reactions to medications as determined by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
The objectives of this study are:
- To evaluate the effect of a low-fat meal on the pharmacokinetics (PK) of vorasidenib following a single oral dose of 40 mg vorasidenib in healthy adult subjects (substudy A)
- To evaluate the effect of multiple-dose ciprofloxacin (strong cytochrome P450 [CYP]1A2 inhibitor) on the single-dose PK of vorasidenib in healthy adult subjects (substudy B)
- Conditions
- Healthy Subjects
- Being tested
- Vorasidenib 40 mg Oral Tablet, Ciprofloxacin 500 mg Oral Tablet, Vorasidenib 10 mg Oral Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vorasidenib 40 mg Oral TabletDrug
Single oral dose of 1×40 mg vorasidenib tablet administered :
- under fasted conditions (all subjects will fast overnight for at least 10 hours prior to dosing and for at least 4 hours after dosing.
- or following a low fat meal (approximatively 400 to 500 calories) (Substudy A)
Ciprofloxacin 500 mg Oral TabletDrug
Twice daily (morning and evening) oral doses of ciprofloxacin 1×500 mg tablet on Days 1 through 14 (Substudy B)
Vorasidenib 10 mg Oral TabletDrug
Single oral dose of vorasidenib 2×10 mg tablets administered on Day 1 (Substudy B)
| Study group | Role | What they receive |
|---|---|---|
| Fasting condition / Low-fat meal | Experimental | A single oral dose of 1×40 mg vorasidenib tablet administered under fasted conditions or following a low-fat meal. Receives: Drug: Vorasidenib 40 mg Oral Tablet |
| Low-fat meal / Fasted condition | Experimental | A single oral dose of 1×40 mg vorasidenib tablet administered following a low-fat meal or under fasted conditions. Receives: Drug: Vorasidenib 40 mg Oral Tablet |
| Vorasidenib | Experimental | Single oral dose of vorasidenib 2×10 mg tablets administered on Day 1. Receives: Drug: Vorasidenib 10 mg Oral Tablet |
| Vorasidenib and ciprofloxacin | Experimental | Single oral dose of vorasidenib 2×10 mg tablets administered on Day 1 and twice daily (morning and evening) oral doses of ciprofloxacin 1×500 mg tablet on Days 1 through 14. Receives: Drug: Ciprofloxacin 500 mg Oral Tablet; Drug: Vorasidenib 10 mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of Vorasidenib (substudy A)
Maximum observed plasma concentration of vorasidenib in substudy A
Measured: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
Tmax of Vorasidenib (substudy A)
Time to maximum observed plasma concentration of vorasidenib in substudy A
Measured: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
AUC0-t of Vorasidenib (substudy A)
Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t) of vorasidenib in substudy A
Measured: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
AUC0-inf of Vorasidenib (substudy A)
AUC from time 0 extrapolated to infinity (AUC0-inf) of vorasidenib in substudy A
Measured: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
Cmax of Vorasidenib (substudy B)
Maximum observed plasma concentration of vorasidenib in substudy B
Measured: Before dosing and at multiple time points up to 504 hours on Day 22 after administration of vorasidenib.
Tmax of Vorasidenib (substudy B)
Time to maximum observed plasma concentration of vorasidenib in substudy B
Measured: Before dosing and at multiple time points up to 504 hours on Day 22 after administration of vorasidenib.
AUC0-t of Vorasidenib (substudy B)
Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t) of vorasidenib in substudy B
Measured: Before dosing and at multiple time points up to 504 hours on Day 22 after administration of vorasidenib.
AUC0-inf of Vorasidenib (substudy B)
AUC from time 0 extrapolated to infinity (AUC0-inf) of vorasidenib in substudy B
Measured: Before dosing and at multiple time points up to 504 hours on Day 22 after administration of vorasidenib.
Secondary outcomes (18)
T1/2 of Vorasidenib (Substudy A)
Half-life f vorasidenib in substudy A
Measured: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
CL/F of Vorasidenib (Substudy A)
Apparent oral clearance of vorasidenib in substudy A
Measured: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
Vz/F of Vorasidenib (Substudy A)
Apparent volume of distribution of vorasidenib in substudy A
Measured: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
Cmax of AGI-69460 (Substudy A)
Maximum observed plasma concentration of AGI-69460 in substudy A
Measured: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
Tmax of AGI-69460 (substudy A)
Time to maximum observed plasma concentration of AGI-69460 (substudy A)
Measured: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
AUC0-t of AGI-69460 (substudy A)
Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t) of AGI-69460 (substudy A)
Measured: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
AUC0-inf of AGI-69460 (substudy A)
AUC from time 0 extrapolated to infinity (AUC0-inf) of AGI-69460 (substudy A)
Measured: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
T1/2 of vorasidenib (substudy B)
Half-life of vorasidenib in substudy B
Measured: Before dosing and at multiple time points up to 504 hours on Day 22 after administration of vorasidenib.
CL/F of vorasidenib (substudy B)
Apparent oral clearance of vorasidenib in substudy B
Measured: Before dosing and at multiple time points up to 504 hours on Day 22 after administration of vorasidenib.
Vz/f
Apparent volume of distribution of vorasidenib in substudy B
Measured: Before dosing and at multiple time points up to 504 hours on Day 22 after administration of vorasidenib.
Cmax of AGI-69460 (substudy B)
Maximum observed plasma concentration of AGI-69460 in substudy B
Measured: Before dosing and at multiple time points up to 504 hours on Day 22 after administration of vorasidenib.
Tmax of AGI-69460 (substudy B)
Time to maximum observed plasma concentration of AGI-69460 (substudy B)
Measured: Before dosing and at multiple time points up to 504 hours on Day 22 after administration of vorasidenib.
AUC0-t of AGI-69460 (substudy B)
Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration of AGI-69460 (substudy B)
Measured: Before dosing and at multiple time points up to 504 hours on Day 22 after administration of vorasidenib.
AUC0-inf of AGI-69460 (substudy B)
AUC from time 0 extrapolated to infinity (AUC0-inf) of AGI-69460 (substudy B)
Measured: Before dosing and at multiple time points up to 504 hours on Day 22 after administration of vorasidenib.
Cmax of ciprofloxacin (substudy B)
Maximum observed plasma concentration of ciprofloxacin in substudy B
Measured: Before dosing on Day 18 and on multiple time points up to 12 h after dosing
Tmax of ciprofloxacin (substudy B)
Tmax of ciprofloxacine (substudy B)
Measured: Before dosing on Day 18 and on multiple time points up to 12 h after dosing
AUC0-t of ciprofloxacin (substudy B)
Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration of ciprofloxacin (substudy B)
Measured: Before dosing on Day 18 and on multiple time points up to 12 h after dosing
AUC0-12 of ciprofloxacin (substudy B)
Area under the plasma concentration versus time curve (AUC) from time 0 to 12h of ciprofloxacin (substudy B)
Measured: Before dosing on Day 18 and on multiple time points up to 12 h after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start14 Apr 2023
- Primary completion28 Jul 2023
- Study completion28 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The substudy A (low-fat meal) is an open-label, randomized, balanced, single-dose, 2-treatment, 2-period, crossover study designed to assess the effect of a low-fat meal on the PK following a single oral dose of 40 mg vorasidenib in healthy adult subjects. The substudy B (CYP1A2 inhibition) is an open-label, nonrandomized, 2-period, 1-sequence crossover study designed to evaluate the effect of multiple-dose ciprofloxacin (strong CYP1A2 inhibitor) on the single-dose PK of vorasidenib in 28 healthy adult subjects
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Servier Bio-Innovation LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut de Recherches Internationales Servier
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843708
- Sponsor's protocol ID
- PKH-95032-009
- Status last verified
- Feb 2025
- First submitted
- 19 Apr 2023
- Last updated
- 14 Feb 2025
- Results posted
- 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 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study to Evaluate the Effect of a Low-Fat Meal and Multiple Doses of Ciprofloxacin on the Pharmacokinetics of Vorasidenib in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05843708
- Acronym / sponsor ID
- PKH-95032-009
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Servier Bio-Innovation LLCIndustry (pharma, biotech, devices)
- Collaborators
- Institut de Recherches Internationales Servier
- Study start
- 14 Apr 2023 (actual)
- Primary completion
- 28 Jul 2023 (actual)
- Study completion
- 28 Jul 2023 (actual)
- First posted
- 6 May 2023 (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 objectives of this study are:
- To evaluate the effect of a low-fat meal on the pharmacokinetics (PK) of vorasidenib following a single oral dose of 40 mg vorasidenib in healthy adult subjects (substudy A)
- To evaluate the effect of multiple-dose ciprofloxacin (strong cytochrome P450 [CYP]1A2 inhibitor) on the single-dose PK of vorasidenib in healthy adult subjects (substudy B)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The substudy A (low-fat meal) is an open-label, randomized, balanced, single-dose, 2-treatment, 2-period, crossover study designed to assess the effect of a low-fat meal on the PK following a single oral dose of 40 mg vorasidenib in healthy adult subjects. The substudy B (CYP1A2 inhibition) is an open-label, nonrandomized, 2-period, 1-sequence crossover study designed to evaluate the effect of multiple-dose ciprofloxacin (strong CYP1A2 inhibitor) on the single-dose PK of vorasidenib in 28 healthy adult subjects
| Arm | Type | Receives |
|---|---|---|
| Fasting condition / Low-fat meal | Experimental | Drug: Vorasidenib 40 mg Oral TabletA single oral dose of 1×40 mg vorasidenib tablet administered under fasted conditions or following a low-fat meal. |
| Low-fat meal / Fasted condition | Experimental | Drug: Vorasidenib 40 mg Oral TabletA single oral dose of 1×40 mg vorasidenib tablet administered following a low-fat meal or under fasted conditions. |
| Vorasidenib | Experimental | Drug: Vorasidenib 10 mg Oral TabletSingle oral dose of vorasidenib 2×10 mg tablets administered on Day 1. |
| Vorasidenib and ciprofloxacin | Experimental | Drug: Ciprofloxacin 500 mg Oral Tablet, Drug: Vorasidenib 10 mg Oral TabletSingle oral dose of vorasidenib 2×10 mg tablets administered on Day 1 and twice daily (morning and evening) oral doses of ciprofloxacin 1×500 mg tablet on Days 1 through 14. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- The subject is male or non-pregnant, non-lactating female 18 to 55 years of age, inclusive.
- The subject has a body mass index 18 to 32 kg/m2, inclusive, at screening.
- The subject has normal hepatic function (aspartate transaminase [AST], alanine transaminase [ALT], total and direct bilirubin, international normalized ratio [INR] all ≤ upper limit of normal [ULN]).
- The subject has normal renal function as evidenced by creatinine clearance >90 mL/min based on the Cockcroft-Gault glomerular filtration rate estimation: (140 - Age) × (Weight in kg) × (0.85 if female) / (72 × serum creatinine).
- The subject is considered by the investigator to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead ECG results, and physical examination findings at screening and check-in.
Key exclusion criteria (34 listed)
- The subject has a history or clinical manifestations of a significant neurological, renal, cardiovascular, gastrointestinal, hepatic, pulmonary, hematologic, immunologic, or psychiatric disease that would preclude study participation, as judged by the investigator.
- The subject has a history (within 5 years prior to screening) or presence of malignancy, except for adequately treated basal cell and squamous cell carcinoma of the skin.
- The subject has a history of severe and/or uncontrolled ventricular arrhythmias, or other factors that increase the risk of QT prolongation or arrhythmic events (eg, heart failure, hypomagnesemia, hypokalemia, family history of long QT interval syndrome) or the subject was taking medications that are known to prolong the QT interval unless they can be safely discontinued ≥30 days or 5 half-lives (whichever is longer) before dosing.
- The subject has any surgical or medical condition(s) possibly affecting drug absorption, distribution, metabolism, and excretion (eg, cholecystectomy, bariatric procedure). Subjects with appendectomy may be included.
- The subject is a woman of childbearing potential who is pregnant, lactating, or planning to become pregnant within 90 days after the last dose of study drug, or the subject is on oral contraceptive pills (moderate CYP1A2 inhibitors) within 14 days or 5 half-lives (whichever is longer) prior to the first dose administration and/or during the 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 |
|---|---|---|
| Vorasidenib 40 mg Oral TabletSingle oral dose of 1×40 mg vorasidenib tablet administered : * under fasted conditions (all subjects will fast overnight for at least 10 hours prior to dosing and for at least 4 hours after dosing. * or following a low fat meal (approximatively 400 to 500 calories) (Substudy A) | Drug | Fasting condition / Low-fat meal, Low-fat meal / Fasted condition |
| Ciprofloxacin 500 mg Oral TabletTwice daily (morning and evening) oral doses of ciprofloxacin 1×500 mg tablet on Days 1 through 14 (Substudy B) | Drug | Vorasidenib and ciprofloxacin |
| Vorasidenib 10 mg Oral TabletSingle oral dose of vorasidenib 2×10 mg tablets administered on Day 1 (Substudy B) | Drug | Vorasidenib, Vorasidenib and ciprofloxacin |
Primary outcome
Cmax of Vorasidenib (substudy A)
Time frame: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
Maximum observed plasma concentration of vorasidenib in substudy A
Tmax of Vorasidenib (substudy A)
Time frame: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
Time to maximum observed plasma concentration of vorasidenib in substudy A
AUC0-t of Vorasidenib (substudy A)
Time frame: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t) of vorasidenib in substudy A
AUC0-inf of Vorasidenib (substudy A)
Time frame: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
AUC from time 0 extrapolated to infinity (AUC0-inf) of vorasidenib in substudy A
Cmax of Vorasidenib (substudy B)
Time frame: Before dosing and at multiple time points up to 504 hours on Day 22 after administration of vorasidenib.
Maximum observed plasma concentration of vorasidenib in substudy B
Tmax of Vorasidenib (substudy B)
Time frame: Before dosing and at multiple time points up to 504 hours on Day 22 after administration of vorasidenib.
Time to maximum observed plasma concentration of vorasidenib in substudy B
AUC0-t of Vorasidenib (substudy B)
Time frame: Before dosing and at multiple time points up to 504 hours on Day 22 after administration of vorasidenib.
Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t) of vorasidenib in substudy B
AUC0-inf of Vorasidenib (substudy B)
Time frame: Before dosing and at multiple time points up to 504 hours on Day 22 after administration of vorasidenib.
AUC from time 0 extrapolated to infinity (AUC0-inf) of vorasidenib in substudy B
18 secondary outcomes
T1/2 of Vorasidenib (Substudy A)
Time frame: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
CL/F of Vorasidenib (Substudy A)
Time frame: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
Vz/F of Vorasidenib (Substudy A)
Time frame: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
Cmax of AGI-69460 (Substudy A)
Time frame: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
Tmax of AGI-69460 (substudy A)
Time frame: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
AUC0-t of AGI-69460 (substudy A)
Time frame: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
AUC0-inf of AGI-69460 (substudy A)
Time frame: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose
T1/2 of vorasidenib (substudy B)
Time frame: Before dosing and at multiple time points up to 504 hours on Day 22 after administration of vorasidenib.
CL/F of vorasidenib (substudy B)
Time frame: Before dosing and at multiple time points up to 504 hours on Day 22 after administration of vorasidenib.
Vz/f
Time frame: Before dosing and at multiple time points up to 504 hours on Day 22 after administration of vorasidenib.
Cmax of AGI-69460 (substudy B)
Time frame: Before dosing and at multiple time points up to 504 hours on Day 22 after administration of vorasidenib.
Tmax of AGI-69460 (substudy B)
Time frame: Before dosing and at multiple time points up to 504 hours on Day 22 after administration of vorasidenib.
AUC0-t of AGI-69460 (substudy B)
Time frame: Before dosing and at multiple time points up to 504 hours on Day 22 after administration of vorasidenib.
AUC0-inf of AGI-69460 (substudy B)
Time frame: Before dosing and at multiple time points up to 504 hours on Day 22 after administration of vorasidenib.
Cmax of ciprofloxacin (substudy B)
Time frame: Before dosing on Day 18 and on multiple time points up to 12 h after dosing
Tmax of ciprofloxacin (substudy B)
Time frame: Before dosing on Day 18 and on multiple time points up to 12 h after dosing
AUC0-t of ciprofloxacin (substudy B)
Time frame: Before dosing on Day 18 and on multiple time points up to 12 h after dosing
AUC0-12 of ciprofloxacin (substudy B)
Time frame: Before dosing on Day 18 and on multiple time points up to 12 h after dosing
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 14 Feb 2025.
- 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 40 mg Oral Tablet, Ciprofloxacin 500 mg Oral Tablet and Vorasidenib 10 mg Oral Tablet in people with Healthy Subjects, run by Servier Bio-Innovation LLC 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 10 inclusion and 34 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 14 Feb 2025. 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?
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 Vorasidenib (substudy A) (time frame: Day 1 before dosing (0 hour) and at multiple time points up to 504 hours post-dose). 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 14 Feb 2025.