Back to search results

A Study on How Fluconazole, Carbamazepine, and Itraconazole Affect ASP3082 in Healthy Adults

This study is looking at how your body processes a medicine called ASP3082 when it's taken with other common medicines: fluconazole, carbamazepine, and itraconazole. ASP3082 is being studied because it might help people with certain cancers that have a faulty KRAS gene (specifically, a G12D mutation). Researchers want to understand if these other medicines change how much ASP3082 stays in your system and for how long. You can join if you are a healthy adult between 18 and 65 years old. The main goal is to measure the levels of ASP3082 in your blood over time. The study is currently recruiting 54 healthy volunteers.

Study design
This is an interventional study involving 54 healthy adult participants. It is not specified if the study is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your blood levels of ASP3082 will be measured for up to 29 days after receiving the medication.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07395024

A Study to Learn How Fluconazole, Carbamazepine and Itraconazole Affect How the Body Processes ASP3082 in Healthy Adults

Active, Not Recruiting
PHASE1Ages 18–65InterventionalBasic science
Astellas Pharma Global Development, Inc.
~54 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:SetidegrasibFluconazoleCarbamazepineItraconazole

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pharmacokinetics (PK) of ASP3082 in plasma: Maximum Concentration (Cmax) in ASP3082
Measured over Up to 29 days
+20 more outcomes measured

Conditions

Healthy Volunteer

Explore related trials

Healthy Volunteer

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Medical Director · STUDY_DIRECTOR · Astellas Pharma Inc

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Participant is healthy and has no clinically significant medical condition based on the physical examination, electrocardiograms (ECGs) and protocol-defined clinical laboratory tests at screening or on day -1.
Female participant is not pregnant and is not a woman of childbearing potential (WOCBP)
Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period and for 5 half-lives (approximately 28 days after final study intervention administration).
Female participant must not donate ova starting at first administration of study intervention and throughout the investigational period and for 3 months after final study intervention administration.
Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 3 months after final study intervention administration.
Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 3 months after final study intervention administration.
Male participant must not donate sperm during the treatment period and for 3 months after final study intervention administration.
Participant agrees not to participate in another interventional study while participating in the present study.
Participant has a Body Mass Index (BMI) range of 18.0 to 32.0 kg/m\^2, inclusive, and weighs at least 50 kg at screening.

Exclusion

Participant is positive for Human Leukocyte Antigen (HLA) -B15:02 or HLA-A31:01, for Group 2 only.
Participant has been pregnant within 6 months prior to screening.
Participant has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease.
Participant has a history of malignancy within 2 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that is considered cured with minimal risk of recurrence).
Participant has had major surgery (e.g., requiring general anesthesia) within 90 days before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study or within 5 half-lives (approximately 28 days) after the last dose of study drug administration or end-of-study visit (ESV), whichever is longer.
Participant has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 28 days prior to day -1.
Participant has a history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) DSM-5 criteria within 2 years before screening.
Participant has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease or a family history of long QT syndrome.
Participant has used any prescribed or nonprescribed drugs (including vitamins, and natural and herbal remedies, e.g., St. John's wort) in the 28 days prior to day -1, except for occasional use of acetaminophen (up to 2 g/day), topical dermatological products (including corticosteroid products) and hormone replacement therapy (HRT).
Participant has used any inducer of metabolism (e.g., barbiturates and rifampin) in the 28 days prior to day -1.
Participant has received a coronavirus disease 2019 (COVID-19) vaccine within the 14 days prior to day -1 or will have a COVID-19 vaccine dose before the ESV.
Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening.
Participant has any liver test result alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST) or total bilirubin (TBL )) ≥ 1.5 ×upper limit of normal (ULN ) on day -1.
Participant has a creatinine level outside normal limits on day -1.
Participant has any of the following conditions on day -1: a mean pulse \< 45 or \> 90 bpm, mean systolic blood pressure (SBP ) \> 140 mmHg, or mean diastolic blood pressure (DBP) \> 90 mmHg (measurements taken in triplicate after participant has been resting in the supine position for at least 5 minutes; pulse measured automatically). If the mean blood pressure exceeds the limits above, 1 additional triplicate measurement may be taken.
Participant has a mean corrected QT interval using Fridericia's formula (QTcF ) of \> 450 msec on day -1.
Participant tests positive for alcohol at screening or on day -1.
Participant tests positive for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine and opiates) at screening or on day -1.
Participant tests positive for cannabinoids on day -1.
Participant has a positive serology test for hepatitis A virus (HAV) antibodies immunoglobulin M (IgM), hepatitis B (HBc) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies or antibodies to human immunodeficiency virus (HIV ) type 1 and/or type 2 at screening.
Participant has a positive rapid COVID-19 antigen test on day -1.
Participant has any condition that makes the participant unsuitable for study participation.
Participant has a known or suspected hypersensitivity to ASP3082 or any components of the formulation used.
Participant has a history of smoking \> 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to day -1 or the participant tests positive for cotinine at screening or day -1.
Participant has a history of consuming \> 10 units of alcoholic beverages per week within 3 months prior to screening (Note: 1 unit = 12 ounces of beer, 5 ounces of wine, 1.5 ounces of spirits/hard liquor).
Participant has used any drugs of abuse (e.g., amphetamines, barbiturates, benzodiazepines, cocaine and/or opiates) within 3 months prior to day -1.
Participant has had significant blood loss, donated ≥ 1 unit (450 mL) of whole blood or donated plasma within 7 days prior to day -1 and/or received a transfusion of any blood or blood products within 60 days prior to day -1.
Participant has had previous exposure to ASP3082.
Participant is an employee of Astellas, the study-related contract research organizations (CROs) or the clinical unit.

What this trial measures

  • Pharmacokinetics (PK) of ASP3082 in plasma: Maximum Concentration (Cmax) in ASP3082Up to 29 days

    Cmax will be recorded from the PK plasma samples collected.

  • PK of ASP3082 in plasma: area under the concentration-time curve from time zero to the time of the last measurable concentration (AUClast) in ASP3082Up to 29 days

    AUClast will be recorded from the PK plasma samples collected.

  • PK of ASP3082 in plasma: area under the concentration-time curve extrapolated to infinity (AUCinf) in ASP3082Up to 29 days

    AUCinf will be calculated from the PK plasma samples collected.

  • PK of ASP3082 in plasma: Cmax in ASP3082+ Fluconazole (FLZ)Up to 29 days

    Cmax will be recorded from the PK plasma samples collected.

  • PK of ASP3082 in plasma: AUClast in ASP3082+FLZUp to 29 days

    AUClast will be recorded from the PK plasma samples collected.

  • PK of ASP3082 in plasma: AUCinf in ASP3082+FLZUp to 29 days

    AUCinf will be calculated from the PK plasma samples collected.

  • Ratio of Cmax of ASP3082 and ASP3082+FLZUp to 29 days

    Ratios of Cmax will be calculated from the PK plasma samples collected.

  • Ratio of AUClast of ASP3082 and ASP3082+FLZUp to 29 days

    Ratios of AUClast will be calculated from the PK plasma samples collected.

  • Ratio of AUCinf of ASP3082 and ASP3082+FLZUp to 29 days

    Ratios of AUCinf will be calculated from the PK plasma samples collected.

  • PK of ASP3082 in plasma: Cmax in ASP3082+ Itraconazole (ITZ)Up to 29 days

    Cmax will be recorded from the PK plasma samples collected.

  • PK of ASP3082 in plasma: AUClast in ASP3082+ITZUp to 29 days

    AUClast will be recorded from the PK plasma samples collected.

  • PK of ASP3082 in plasma: AUCinf in ASP3082+ITZUp to 29 days

    AUCinf will be calculated from the PK plasma samples collected.

  • Ratio of Cmax of ASP3082 and ASP3082+ITZUp to 29 days

    Ratios of Cmax will be recorded from the PK plasma samples collected.

  • Ratio of AUClast for ASP3082 and ASP3082+ITZUp to 29 days

    Ratios of AUClast will be recorded from the PK plasma samples collected.

  • Ratio of AUCinf for ASP3082 and ASP3082+ITZUp to 29 days

    Ratios of AUCinf will be calculated from the PK plasma samples collected.

  • PK of ASP3082 in plasma: Cmax in ASP3082+ Carbamazepine (CAR)Up to 29 days

    Cmax will be recorded from the PK plasma samples collected.

  • PK of ASP3082 in plasma: AUClast in ASP3082+CARUp to 29 days

    AUClast will be recorded from the PK plasma samples collected.

  • PK of ASP3082 in plasma: AUCinf in ASP3082+CARUp to 29 days

    AUCinf will be calculated from the PK plasma samples collected.

  • Ratio of Cmax of ASP3082 and ASP3082+CARUp to 29 days

    Ratios of Cmax will be calculated from the PK plasma samples collected.

  • Ratio of AUClast for ASP3082 and ASP3082+CARUp to 29 days

    Ratios of AUClast will be calculated from the PK plasma samples collected.

  • Ratio of AUCinf for ASP3082 and ASP3082+CARUp to 29 days

    Ratios of AUCinf will be calculated from the PK plasma samples collected.