Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07395024 · ClinicalTrials.gov registry record · Phase 1
A Study to Learn How Fluconazole, Carbamazepine and Itraconazole Affect How the Body Processes ASP3082 in Healthy Adults
A Phase 1 study of Healthy Volunteer, sponsored by Astellas Pharma Global Development.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
- 1
- Study location
NCT07395024: Recruiting Phase 1 study of Healthy Volunteer, sponsored by Astellas Pharma Global Development.
NCT07395024 is a Phase 1 study of Healthy Volunteer that is actively recruiting participants, run by Astellas Pharma Global Development. The registered enrollment target is 54 participants, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07395024, a Phase 1 study of Healthy Volunteer, is actively recruiting participants, sponsored by Astellas Pharma Global Development.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
- 1
- Study location
Study Summary
Genes give your body instructions on how to make proteins. Proteins are needed to keep the body working properly. Many types of cancer are caused by changes in certain genes, making them faulty. Some people with solid tumors have a faulty KRAS gene. One such change in the KRAS gene is called a G12D mutation. Researchers are looking for ways to stop the actions of abnormal proteins made from the KRAS G12D mutation. ASP3082 is thought to replace some of the abnormal proteins made from the faulty KRAS gene. If other medicines are given at the same time as ASP3082, they may affect how the body processes ASP3082. In this study, fluconazole, itraconazole and carbamazepine are given with ASP3082 in healthy adults. The main aims are to check if fluconazole, itraconazole and carbamazepine affect how the body processes ASP3082. These medicines may affect how the body processes ASP3082 when they are taken at the same time. This study will have 3 groups of adults. One group will be given fluconazole and ASP3082, the second group will be given carbamazepine and ASP3082, and the third group will be given itraconazole and ASP3082. ASP3082 will be given to people slowly through a tube into the vein (infusion). Fluconazole and carbamazepine will be given as a tablet and itraconazole will be given as a liquid by mouth. People will be given study treatments for about 1 month. They will then return to the clinic about 1 week after they finish study treatment for a final safety check.
Primary Outcome
Cmax will be recorded from the PK plasma samples collected.
Conditions Studied
Interventions
- DRUG Fluconazole
- DRUG Itraconazole
- DRUG Setidegrasib
- DRUG Carbamazepine
Study Locations (1)
Maryland
- Parexel - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2026-02-03 |
| Est. Completion | 2026-07-31 |
| Phase | Phase 1 |
What NCT07395024 shows while recruiting
NCT07395024 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 201-participant average among 112 other Healthy Volunteer trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Healthy Volunteer appearing as the primary indexed condition, and to 4 interventions - of which Fluconazole is the first listed.
NCT07395024 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT07395024 about?
NCT07395024 is a clinical study titled "A Study to Learn How Fluconazole, Carbamazepine and Itraconazole Affect How the Body Processes ASP3082 in Healthy Adults". Genes give your body instructions on how to make proteins. Proteins are needed to keep the body working properly. Many types of cancer are caused by changes in certain genes, making them faulty. Some people with solid tumors have a faulty KRAS gene. One such change in the KRAS gene is called a G12D ...
What is the current status of trial NCT07395024?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2026-02-03. Estimated completion is 2026-07-31.
What conditions does trial NCT07395024 study?
This clinical trial studies the following conditions: Healthy Volunteer.
What interventions are being tested in trial NCT07395024?
The interventions under investigation include: Fluconazole (DRUG), Itraconazole (DRUG), Setidegrasib (DRUG), Carbamazepine (DRUG).
Who is sponsoring clinical trial NCT07395024?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07395024 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy Volunteer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07395024's enrollment target sits among peer trials
54 57th of 112 higher than 56 of 112 other Healthy Volunteer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Healthy Volunteer Study
RECRUITING · Phase 1
-
Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder
RECRUITING · Phase 1
-
Role of Metal Ion Transporter ZIP8 in Alcohol-Related Behaviors
RECRUITING · Phase 1
-
A First-in-Human Single and Multiple Ascending Dose Study of MT-201
RECRUITING · Phase 1
-
A Study to Assess the Adverse Events and How Oral Emraclidine Moves Through the Body of Healthy Elderly Adult Participants
RECRUITING · Phase 1
-
A Study to Assess How the Drug Moves Through the Body, Adverse Events, and Tolerability of Oral ABBV-722 Capsules of Single and Multiple Ascending Doses in Adult Participants and Single Doses in Adult Asian Participants
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01269853 · 54 participants · Phase 1
Repeated Super-selective Intraarterial Cerebral Infusion of Bevacizumab (Avastin) for Treatment of Relapsed GBM and AA
- NCT02390752 · 54 participants · Phase 1
Phase I Trial of TURALIO(R) (Pexidartinib, PLX3397) in Children and Young Adults With Refractory Leukemias and Refractory Solid Tumors Including Neurofibromatosis Type 1 (NF1) Associated Plexiform Neurofibromas (PN) and Tenosynovial Giant Cell Tumor ...
- NCT02991248 · 54 participants · NA
Improve Dynamic Lateral Balance of Humans With SCI
- NCT02993900 · 54 participants · NA
Image-Guided Gynecologic Brachytherapy
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI