A Clinical Trial to Evaluate MK-4208/Embibatinib in Healthy Adult Participants (MK-4208-001/Embibatinib-1014)
- Summary
- The goal of the study is to learn what happens to different doses and forms of Embibatinib in a healthy person's body over time. Researchers will compare what happens to different doses and forms of Embibatinib in a person's body over time when given with or without food, or with or without other medications. The goal of the study is to learn: * What happens to different doses of Embibatinib in a person's body over time when it is given with or without food, or with or without other medications. * About the safety of Embibatinib and if people tolerate it
- Short title
- A Clinical Trial to Evaluate MK-4208/Embibatinib in Healthy Adult Participants (MK-4208-001/Embibatinib-1014)
- Official title
- A Phase 1 Clinical Trial in Healthy Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Embibatinib, the Effects of Food, Acid-Reducing Agents, and Drug-Drug Interactions, and the Relative Bioavailability of New Tablet Formulations of Embibatinib.
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2026-06-30
- First posted
- 2026-09-24
- Registry last updated
- 2026-10-22
- Primary completion date
- 2026-06-30
- Start date
- 2023-12-21
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07838987
- ClinicalTrials.gov ID
- NCT07838987
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Sequential
- Purpose
- Basic science
- Masking
- No masking
Number of Participants Who Experience a Treatment Emergent Adverse Event (AE)
Timeframe: Up to approximately 102 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience a treatment emergent AE will be reported.
Number of Participants Who Discontinue Study Treatment Due to an AE
Timeframe: Up to approximately 102 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
Number of Participants with Clinically Significant Abnormalities in Systolic Blood Pressure
Timeframe: up to approximately 102 days
Blood pressure will be measured after the participant has been at rest in a supine position for at least 10 minutes. Blood pressure and pulse measurements will be assessed with a completely automated device; manual techniques will be used only if an automated device is not available. Blood pressure measurements will be carried out before blood sample collections or at least 30 minutes after any blood draws.
Number of Participants with Clinically Significant Abnormalities in Diastolic Blood Pressure
Timeframe: up to approximately 102 days
Blood pressure will be measured after the participant has been at rest in a supine position for at least 10 minutes. Blood pressure and pulse measurements will be assessed with a completely automated device; manual techniques will be used only if an automated device is not available. Blood pressure measurements will be carried out before blood sample collections or at least 30 minutes after any blood draws.
Number of Participants with Abnormal Clinical Hematology Test Results Reported as Adverse Events
Timeframe: up to approximately 102 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with abnormal hematology-related AEs will be reported.
Number of Participants with Abnormal Clinical Chemistry Test Results Reported as Adverse Events
Timeframe: up to approximately 102 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with abnormal chemistry-related AEs will be reported.
Number of Participants with Abnormal Urinalysis Results Reported as Adverse Events
Timeframe: up to approximately 102 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with abnormal urinalysis-related AEs will be reported.
Number of Participants with Clinically Significant Abnormalities in 12-Lead (ECG) Findings
Timeframe: up to approximately 102 days
During the 12-lead ECG collection participants will be instructed to lie supine for at least 10 minutes prior to ECG collection. During the collection, participants should be in a quiet setting, without distractions, and should refrain from talking or moving their arms or legs. All ECG acquisitions will be carried out before any blood sample collections or at least 30 minutes after any blood draws.
Area Under the Concentration versus Time Curve from Time 0 to the Last Quantifiable Concentration (AUC0-last) of Embibatinib in Plasma
Timeframe: Pre-dose and at designated time points up to 96 hours post dose
Blood samples will be collected to determine the AUC0-Last of Embibatinib.
Area Under the Concentration versus Time Curve Extrapolated to Infinite Time (AUC0-Inf) of Embibatinib in Plasma
Timeframe: Pre-dose and at designated time points up to 96 hours post dose
Blood samples will be collected to determine the AUC0-inf of Embibatinib.
Area Under the Concentration versus Time Curve Over the Dosing Interval (AUCtau) of Embibatinib in Plasma
Timeframe: Pre-dose and at designated time points up to 24 hours post dose
Blood samples will be collected to determine the AUCtau of Embibatinib.
Maximum Observed Concentration of Drug (Cmax) of Embibatinib in Plasma
Timeframe: Pre-dose and at designated time points up to 96 hours post dose
Blood samples will be collected to determine the Cmax of Embibatinib.
Apparent Terminal Elimination Half-Life (t1/2) of Embibatinib in Plasma
Timeframe: Pre-dose and at designated time points up to 96 hours post dose
Blood samples will be collected to determine the t1/2 of Embibatinib.
Time of Maximum Observed Concentration of Drug (Tmax) of Embibatinib in Plasma
Timeframe: Pre-dose and at designated time points up to 96 hours post dose
Blood samples will be collected to determine the Tmax of Embibatinib.
AUC0-last of Embibatinib in Plasma Under Fed Versus Fasted Conditions
Timeframe: Pre-dose and at designated time points up to 96 hours post dose
Blood samples will be collected to determine the AUC0-Last of Embibatinib under fed versus fasted conditions.
AUC0-Inf of Embibatinib in Plasma Under Fed Versus Fasted Conditions
Timeframe: Pre-dose and at designated time points up to 96 hours post dose
Blood samples will be collected to determine the AUC0-inf of Embibatinib under fed versus fasted conditions.
Cmax of Embibatinib in Plasma Under Fed Versus Fasted Conditions
Timeframe: Pre-dose and at designated time points up to 96 hours post dose
Blood samples will be collected to determine the Cmax of Embibatinib under fed versus fasted conditions.
Tmax of Embibatinib in Plasma Under Fed Versus Fasted Conditions
Timeframe: Pre-dose and at designated time points up to 96 hours post dose
Blood samples will be collected to determine the Tmax of Embibatinib under fed versus fasted conditions.
AUC0-last of Embibatinib Formulations in Plasma
Timeframe: Pre-dose and at designated time points up to 96 hours post dose
Blood samples will be collected to determine the AUC0-Last of Embibatinib formulations.
AUC0-Inf of Embibatinib Formulations in Plasma
Timeframe: Pre-dose and at designated time points up to 96 hours post dose
Blood samples will be collected to determine the AUC0-Inf of Embibatinib formulations.
Cmax of Embibatinib Formulations in Plasma
Timeframe: Pre-dose and at designated time points up to 96 hours post dose
Blood samples will be collected to determine the Cmax of Embibatinib formulations.
AUC0-last of Embibatinib in Plasma Administered With or Without an Acid-Reducing Agent
Timeframe: Pre-dose and at designated time points up to 96 hours post dose
Blood samples will be collected to determine the AUC0-Last of Embibatinib administered with or without an acid-reducing agent.
AUC0-Inf of Embibatinib in Plasma Administered With or Without an Acid-Reducing Agent
Timeframe: Pre-dose and at designated time points up to 96 hours post dose
Blood samples will be collected to determine the AUC0-inf of Embibatinib administered with or without an acid-reducing agent.
Cmax of Embibatinib in Plasma Administered With or Without an Acid-Reducing Agent
Timeframe: Pre-dose and at designated time points up to 96 hours post dose
Blood samples will be collected to determine the Cmax of Embibatinib administered with or without an acid-reducing agent.
AUC0-last of Midazolam in Plasma Administered With or Without Embibatinib
Timeframe: Pre-dose and at designated time points up to 96 hours post dose
Blood samples will be collected to determine the AUC0-Last of Midazolam administered with or without Embibatinib.
AUC0-Inf of Midazolam in Plasma Administered With or Without Embibatinib
Timeframe: Pre-dose and at designated time points up to 96 hours post dose
Blood samples will be collected to determine the AUC0-inf of Midazolam administered with or without Embibatinib.
Cmax of Midazolam in Plasma Administered With or Without Embibatinib
Timeframe: Pre-dose and at designated time points up to 96 hours post dose
Blood samples will be collected to determine the Cmax of Midazolam administered with or without Embibatinib.
AUC0-last of Montelukast in Plasma Administered With or Without Embibatinib
Timeframe: Pre-dose and at designated time points up to 96 hours post dose
Blood samples will be collected to determine the AUC0-Last of Montelukast administered with or without Embibatinib.
AUC0-Inf of Montelukast in Plasma Administered With or Without Embibatinib
Timeframe: Pre-dose and at designated time points up to 96 hours post dose
Blood samples will be collected to determine the AUC0-inf of Montelukast administered with or without Embibatinib.
Cmax of Montelukast in Plasma Administered With or Without Embibatinib
Timeframe: Pre-dose and at designated time points up to 96 hours post dose
Blood samples will be collected to determine the Cmax of Montelukast administered with or without Embibatinib.
AUC0-last of Omeprazole in Plasma Administered With or Without Embibatinib
Timeframe: Pre-dose and at designated time points up to 96 hours post dose
Blood samples will be collected to determine the AUC0-Last of Omeprazole administered with or without Embibatinib.
AUC0-Inf of Omeprazole in Plasma Administered With or Without Embibatinib
Timeframe: Pre-dose and at designated time points up to 96 hours post dose
Blood samples will be collected to determine the AUC0-inf of Omeprazole administered with or without Embibatinib.
Cmax of Omeprazole in Plasma Administered With or Without Embibatinib
Timeframe: Pre-dose and at designated time points up to 96 hours post dose
Blood samples will be collected to determine the Cmax of Omeprazole administered with or without Embibatinib.
AUC0-last of Digoxin in Plasma Administered With or Without Embibatinib
Timeframe: Pre-dose and at designated time points up to 96 hours post dose
Blood samples will be collected to determine the AUC0-Last of Digoxin administered with or without Embibatinib.
AUC0-Inf of Digoxin in Plasma Administered With or Without Embibatinib
Timeframe: Pre-dose and at designated time points up to 96 hours post dose
Blood samples will be collected to determine the AUC0-inf of Digoxin administered with or without Embibatinib.
Cmax of Digoxin in Plasma Administered With or Without Embibatinib
Timeframe: Pre-dose and at designated time points up to 96 hours post dose
Blood samples will be collected to determine the Cmax of Digoxin administered with or without Embibatinib.
AUC0-last of Pravastatin in Plasma Administered With or Without Embibatinib
Timeframe: Pre-dose and at designated time points up to 96 hours post dose
Blood samples will be collected to determine the AUC0-Last of Pravastatin administered with or without Embibatinib.
AUC0-Inf of Pravastatin in Plasma Administered With or Without Embibatinib
Timeframe: Pre-dose and at designated time points up to 96 hours post dose
Blood samples will be collected to determine the AUC0-inf of Pravastatin administered with or without Embibatinib.
Cmax of Pravastatin in Plasma Administered With or Without Embibatinib
Timeframe: Pre-dose and at designated time points up to 96 hours post dose
Blood samples will be collected to determine the Cmax of Pravastatin administered with or without Embibatinib.
And 15 more, listed on the interactive page.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Healthy volunteers
- Yes
The main inclusion criteria include but are not limited to the following:
- Has body weight ≥48 kg (105.6 lbs) and body mass index within the range of 18.5 to 32 kg/m^2 (inclusive)
- Is in good health
The main exclusion criteria include but are not limited to the following:
- Has history or clinical manifestation of any metabolic, allergic, autoimmune, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, ocular, respiratory, endocrine, or psychiatric disorder, or any condition that would affect drug absorption, distribution, metabolism, or excretion (eg, stomach or intestinal surgery, or gallbladder removal/cholecystectomy). Uncomplicated appendectomy and hernia repair will be allowed.
- Has history of QT prolongation syndrome, unexplained syncope, family history of sudden death, atrial fibrillation, malignant tumor, mental disorder, or any major disease
- Has positive screening test for Hepatitis B surface antigen, anti-Hepatitis C virus antibodies, or anti-Human immunodeficiency virus (HIV) 1 and 2 antibodies
- Has any known history of bleeding, or prothrombin time (Embibatinib + Probe Substrate Cocktail-2 arm only)
- ICONMillcreek, United States
- Related resource (www.merckclinicaltrials.com)
- MK-4208-001
- TERN701-1014
Related records
Drugs (11)
- Bosentan
- Digoxin
- Itraconazole
- Midazolam
- Montelukast
- Omeprazole
- Pravastatin
- Quinidine
- Rabeprazole
- Rosuvastatin
- Warfarin