A Study to Learn About How Itraconazole and Carbamazepine Affect the Level of BAY2927088 in the Blood When These Drugs Are Taken Together by Healthy Participants
Public ClinicalTrials.gov record NCT06348888. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1 Open Label, Two-arm, Fixed Sequence, Crossover Study to Investigate the Effects of Itraconazole and Carbamazepine on the Pharmacokinetics of BAY 2927088 in Healthy Participants
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called EGFR and HER2 mutations. Advanced NSCLC refers to a type of lung cancer that has spread from the lungs to nearby tissues or other body parts. People with advanced NSCLC may have changes in certain proteins like EGFR and HER2, that cause uncontrolled cell growth and increased spread of cancer. In this study, participants will be healthy and will not benefit from taking the study treatment, BAY2927088. However, the study will provide information about how to test BAY2927088 in future studies with people who have advanced NSCLC with EGFR or HER2 mutations. BAY2927088 is under development for the treatment of advanced NSCLC with EGFR or HER2 mutations. It is expected to work against these changed proteins, which might slow down the spread of cancer. BAY2927088 is broken down by an enzyme called CYP3A4 inside the body. Itraconazole is a drug that inhibits the activity of CYP3A4 while carbamazepine is a drug that enhances the activity of CYP3A4. Giving these drugs together will allow researchers to learn how the blood levels of BAY2927088 change when the CYP3A4 activity is inhibited or enhanced. The main purpose of this study is to find out how itraconazole and carbamazepine may affect the blood levels of BAY2927088. For this, researchers will measure the following for BAY2927088 when it is given with and without itraconazole and carbamazepine * Area under the curve (AUC): a measure of the total amount of BAY2927088 in participants' blood over time * Maximum observed concentration (Cmax): the highest amount of BAY2927088 in participants' blood The study will have 2 treatment groups. In Group 1, participants will take: * BAY2927088 as a single dose on Days 1 and 8. * Itraconazole once daily on Days 5 to 11. In Group 2, participants will take: * BAY2927088 as a single dose on Days 1 and 14. * Different doses of carbamazepine two times a day on Days 3 to 15. Participants will be in this study for about 7 weeks in Group 1 and 8 weeks in Group 2. Participants will visit the study clinic: * at least once, 2 to 28 days before the treatment starts in both groups, to confirm they can take part in this study * on Day 1, and will stay at the clinic until Day 12 in Group 1 and Day 16 in Group 2 * once, 7 to 10 days later from last dose of BAY2927088 in both groups, for a health check up During the study, the doctors and their study team will: * perform physical examinations * collect blood samples from the participants to measure the levels of BAY2927088 * check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram (ECG) * ask the participants questions about how they are feeling and what adverse events they are having An adverse event is any medical problem that a participant has during a study. The study doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.
Study identification
- NCT ID
- NCT06348888
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 30 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 9, 2024
- Primary completion
- Jun 11, 2024
- Completion
- Jun 11, 2024
- Last update posted
- Jun 19, 2024
2024
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Parexel Baltimore - Early Phase Clinical Unit | Baltimore | Maryland | 21225 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06348888, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 19, 2024 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06348888 live on ClinicalTrials.gov.