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New treatment option for Healthy Volunteer
Official title A Study to Learn How Fluconazole, Carbamazepine and Itraconazole Affect How the Body Processes ASP3082 in Healthy Adults
ClinicalTrials.gov ID: NCT07395024
What this study is testing
What is Setidegrasib?
Setidegrasib is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for healthy volunteer.
Also referred to as ASP3082.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Genes give your body instructions on how to make proteins. Proteins are needed to keep the body working properly.
- Phase 1: an early, usually small safety study
- Time commitment: about 1 month
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Participant is healthy and has no clinically significant medical condition based on the physical examination, electrocardiograms (ECGs) and...
- 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...
- Female participant must not donate ova starting at first administration of study intervention and throughout the investigational period and for 3...
- Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the...
You likely can't join if
- 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...
- Participant has a history of malignancy within 2 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma...
- Participant has had major surgery (e.g., requiring general anesthesia) within 90 days before screening, or will not have fully recovered from...
- Participant has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection...
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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 treatment 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.
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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 \ 90 bpm, mean systolic blood pressure (SBP ) \> 140 mmHg, or mean diastolic blood pressure (DBP) \> 90 mmHg (measurements taken in triplicate...
- 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...
- 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...
- Participant has had previous exposure to ASP3082.
- Participant is an employee of Astellas, the study-related contract research organizations (CROs) or the clinical unit.
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 1 month per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.