Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06221475
Other study ID # 22249
Secondary ID 2022-502771-38-0
Status Completed
Phase Phase 1
First received
Last updated
Start date January 25, 2024
Est. completion date April 5, 2024

Study information

Verified date April 2024
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Researchers are looking for a better way to treat men who have advanced non-small cell lung cancer (NSCLC). NSCLC is a group of lung cancers that have spread to nearby tissues or to other parts of the body. Epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) are proteins that help cells to grow and divide. A damage (also called mutation) to the building plans (genes) for these proteins in cancer cells leads to a production of abnormal EGFR and/or HER2. These abnormal proteins drive the growth and the spread of the cancer. Several EGFR and/or HER2 mutations exist in the cancer cells. The study treatment works by blocking the mutated EGFR and HER2 protein present in NSCLC cells and may help stop the further spread of NSCLC. BAY2927088 is under development, once it is approved, it may help treat people with NSCLC. The participants of this study will be healthy men and will have no benefit from the administration of BAY2927088. However, the study will provide important information for the design of subsequent studies with BAY2927088 in people with NSCLC. The participants in this study will get the non-radiolabeled and radio-labeled study treatment BAY2927088 in the form of tablets and solution by mouth and as an intravenous infusion in the arm. By radiolabeling the study treatment, researchers can track its movement and breakdown in the body of the participants. During the study, the study team will do physical examinations, take medical history, ask the participants questions about their smoking or alcohol consumption habits and other medications used, check vital signs such as blood pressure, heart rate, body temperature and the number of breaths taken per minute (respiratory rate), take blood and urine samples, do HIV (human immunodeficiency virus), hepatitis and optional COVID-19 tests per local regulations, and examine heart health using electrocardiogram (ECG). Each study participant will go through a first test phase (screening) of up to 28 days before the start of treatment. The study will have two parts. In part 1, the study participants will take a single dose of the non-radiolabeled study treatment in the form of tablets by mouth 30 minutes following a light meal. They will then receive the radiolabeled study treatment as an intravenous infusion in the arm over 15 minutes. After 2 days of washout, the same group of participants will move on to Part 2 of the study. They will take a single dose of the radio-labeled study treatment as a solution by mouth 30 minutes after a light meal. The participants and the study team know what treatment the participants will take. The total duration of the study will be approximately 8 weeks per participant, including an in house stay of approximately 23 days and 22 nights. There will be a final examination on the last day of their in-house stay before the participants are discharged and go home. The study doctors and their team will contact the participant to learn about the participant's health until the participant completes the study.


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date April 5, 2024
Est. primary completion date April 5, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - Capable of giving signed informed consent - Participant must be 18 or age of legal maturity to 55 years of age inclusive, at the time of signing the informed consent - Participants who are overtly healthy as determined by the investigator or medically qualified designee based on medical evaluation including medical history, laboratory tests, physical, cardiac, and neurologic examination - Body mass index (BMI) within the range [18 - 30] kg/m^2 (inclusive), with bodyweight above/equal to 50 kg - Male - Study participants of reproductive potential must agree to use adequate contraception when sexually active during the study period and for at least 3 months after the last dose of study intervention, and refrain from donating sperm during this period - Participant must have venous access sufficient to allow blood sampling as required by the protocol - Participant must be willing to undergo multiple blood draws as required by the protocol - Participant must be willing to comply with dietary and fluid requirements during the treatment period (including abstaining from alcohol use) - Ability to understand and follow study-related instructions Exclusion Criteria: - Existing relevant diseases of vital organs (e.g., liver diseases, heart diseases, gastrointestinal diseases, interstitial lung disease), central nervous system (for example seizures) or other organs (e.g., diabetes mellitus) - Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, and effects of the study intervention will not be normal - Any relevant diseases within 4 weeks prior to the first study intervention administration as judged by the investigator - A medical history of risk factors for Torsades de pointes (e.g., family history of long QT syndrome) or other clinically significant arrhythmias as judged by the investigator - Known history of hypersensitivity (or known allergic reaction) to BAY2927088-related compounds, or any components of the formulation - History of known or suspected malignant tumors - Participants with any type of psychiatric disorder, especially any mood disorders including medical history with suicidal ideation and/or suicide attempts, which may disable the participant to consent - Any condition which may result in longer than usual retention of urine or feces in the body, such as pronounced (less than one defecation in 3 days) constipation or symptomatic prostatic hypertrophy - Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton [excluding spinal column]), during work or during participation in a clinical study in the period of 1 year prior to screening - Participant will be excluded when he participated in another study with a radiation burden of 0.1 - 1 mSv (inclusive) in the period of 1 year prior to screening; 1.1 - 2 mSv (inclusive) in the period of 2 years prior to screening; 2.1 - 3 mSv (inclusive) in the period of 3 years prior to screening, etc. (add 1 year per 1 mSv)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BAY2927088 coated tablet 10 mg
4 coated tablets (10 mg) per single dose 30 min after a light meal
[14C]-BAY2927088 solution for infusion
IV infusion 15 min ending at 2 hours oral post-dose
[14C]-BAY2927088 oral solution
After a light meal

Locations

Country Name City State
Netherlands ICON plc Groningen

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary For Part 1: Absolute bioavailability (F) as percent F (%F) after oral administration as oral to IV ratio of AUC/D (Area under the concentration curve per dose) Day 1 of Part 1 pre-dose and at multiple time points (up to 3 days) post-dose
Primary For Part 1: AUC of BAY2927088 and [14C]-BAY2927088 Day 1 of Part 1 pre-dose and at multiple time points (up to 3 days) post-dose
Primary For Part 1: AUC/D of BAY2927088 and [14C]-BAY2927088 Day 1 of Part 1 pre-dose and at multiple time points (up to 3 days) post-dose
Primary For Part 1: Cmax (maximum concentration) of BAY2927088 and [14C]-BAY2927088 Day 1 of Part 1 pre-dose and at multiple time points (up to 3 days) post-dose
Primary For Part 1: Cmax/D of BAY2927088 and [14C]-BAY2927088 Day 1 of Part 1 pre-dose and at multiple time points (up to 3 days) post-dose
Primary For Part 2: Amount of BAY2927088 and its metabolites excreted in urine (%AEur), in feces (%AEfec), and in vomit as a percent of the dose (%AEvom, if applicable) Based on radioactivity excreted in urine and feces, and vomit as a percentage of the dose to assess mass balance of total radioactivity Day 1 of Part 2 pre-dose and at multiple time points (minimum up to 6 days, maximum up to 6 weeks) post-dose
Primary For Part 2: AUC of total radioactivity in plasma and whole blood. (AUC(0-tlast) will be used as primary parameter if mean AUC(tlast-8) >20% of AUC) Day 1 of Part 2 pre-dose and at multiple time points (minimum up to 6 days, maximum up to 6 weeks) post-dose
Primary For Part 2: Cmax of total radioactivity in plasma and whole blood Day 1 of Part 2 pre-dose and at multiple time points (minimum up to 6 days, maximum up to 6 weeks) post-dose
Primary For Part 2: AUC of BAY2927088 in plasma. (AUC[0-tlast] will be used as primary parameter if mean AUC[tlast-8] >20% of AUC) Day 1 of Part 2 pre-dose and at multiple time points (minimum up to 6 days, maximum up to 6 weeks) post-dose
Primary For Part 2: Cmax of BAY2927088 in plasma Day 1 of Part 2 pre-dose and at multiple time points (minimum up to 6 days, maximum up to 6 weeks) post-dose
Secondary Number of participants with treatment-emergent adverse events (TEAE) and severity of treatment-emergent adverse events From dosing up to 15 days after last dosing
See also
  Status Clinical Trial Phase
Completed NCT05001152 - Taste Assessment of Ozanimod Phase 1
Completed NCT05029518 - 3-Way Crossover Study to Compare the PK (Pharmokinetics) and to Evaluate the Effect of Food on the Bioavailability Phase 1
Completed NCT04493255 - A Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male Participants Phase 1
Completed NCT03457649 - IV Dose Study to Assess the Safety, Tolerability, PK, PD and Immunogenicity of ARGX-113 in Healthy Volunteers Phase 1
Completed NCT00995891 - Collection of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) Laboratory Research Studies
Completed NCT05043766 - Evaluation of Oral PF614 Relative to OxyContin Phase 1
Completed NCT05050318 - Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2021-2022 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively Phase 4
Completed NCT04466748 - A Multiple Ascending Dose Pharmacology Study of Anaprazole in Healthy Chinese Subjects Phase 1
Completed NCT00746733 - Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC Phase 1
Recruiting NCT05929651 - Study of Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Toddlers 12 to 23 Months, Regardless of the Quadrivalent Meningococcal Conjugate Vaccine Used for Priming in Infancy Phase 4
Completed NCT05954039 - Evaluation of the Efficacy of a Dietary Supplement on Hair Loss and Hair Aspect N/A
Completed NCT05045716 - A Study of Subcutaneous Lecanemab in Healthy Participants Phase 1
Active, not recruiting NCT02747927 - Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children Phase 3
Completed NCT05533801 - A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants Phase 1
Not yet recruiting NCT03931369 - Adaptation of Thirst to a Single Administration of Tolvaptan (TOLVATHIRST) Phase 2
Completed NCT03279146 - A Single Dose Study Evaluating PK of TXL Oral Formulations in Healthy Subjects Phase 1
Completed NCT06027437 - A Study to Assess the Relative Biological Availability and the Effect of Food on the Drug Levels of Danicamtiv in Healthy Adult Participants Phase 1
Recruiting NCT05619874 - Effects of Two Virtual HIFCT Programs in Adults With Abdominal Obesity N/A
Completed NCT05553418 - Investigational On-body Injector Clinical Study N/A
Completed NCT04092712 - Study Evaluating Pharmacokinetics and Mass Balance of [14C]-CTP-543 in Healthy Adult Male Volunteers Phase 1