A Clinical Trial to Evaluate MK-4208/TERN-701 in Healthy Adult Participants (MK-4208-001/TERN701-1014)

Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)196 enrolled

Overview

The goal of the study is to learn what happens to different doses and forms of TERN-701 in a healthy person's body over time. Researchers will compare what happens to different doses and forms of TERN-701 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 TERN-701 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 TERN-701 and if people tolerate it

Per protocol, participants will be randomized in Cohort 7 to the sequence in which they receive two TERN-701 formulations. All other cohorts will be non-randomized.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

196

Conditions

Healthy

Interventions

RabeprazoleDRUG

The United States commercially marketed 20 mg oral tablet formulation is being used in this trial.

MidazolamDRUG

2 mg oral syrup formulation administered as part of the probe substrate cocktail-1 and probe substrate cocktail-2. The United States commercially marketed formulation is being used in this trial.

DigoxinDRUG

0.25 mg oral tablet formulation administered as part of the probe substrate cocktail-1. The United States commercially marketed formulation is being used in this trial.

PravastatinDRUG

40 mg oral tablet formulation administered as part of the probe substrate cocktail-1. The United States commercially marketed formulation is being used in this trial.

MontelukastDRUG

10 mg oral tablet formulation administered as part of the probe substrate cocktail-1. The United States commercially marketed formulation is being used in this trial.

OmeprazoleDRUG

40 mg oral tablet formulation administered as part of the probe substrate cocktail-1. The United States commercially marketed formulation is being used in this trial.

ItraconazoleDRUG

The United States commercially marketed 200 mg oral capsule formulation is being used in this trial.

WarfarinDRUG

5 mg oral tablet formulation administered as part of the probe substrate cocktail-2. The United States commercially marketed formulation is being used in this trial.

RosuvastatinDRUG

10 mg oral tablet formulation administered as part of the probe substrate cocktail-2. The United States commercially marketed formulation is being used in this trial.

BosentanDRUG

The Europe commercially marketed 125 mg oral tablet formulation is being used in this trial.

QuinidineDRUG

The United States commercially marketed 300 mg oral tablet formulation is being used in this trial.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 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 Exclusion Criteria: 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 (TERN-701 + Probe Substrate Cocktail-2 arm only)

Locations (1)

ICON

Millcreek, Utah, United States

Outcomes

Primary Outcomes

Number of Participants Who Experience a Treatment Emergent Adverse Event (AE)

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.

Time frame: Up to approximately 102 days

Number of Participants Who Discontinue Study Treatment Due to an AE

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.

Time frame: Up to approximately 102 days

Number of Participants with Clinically Significant Abnormalities in Systolic Blood Pressure

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.

Time frame: up to approximately 102 days

Number of Participants with Clinically Significant Abnormalities in Diastolic Blood Pressure

Time frame: up to approximately 102 days

Number of Participants with Abnormal Clinical Hematology Test Results Reported as Adverse Events

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.

Time frame: up to approximately 102 days

Number of Participants with Abnormal Clinical Chemistry Test Results Reported as Adverse Events

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.

Time frame: up to approximately 102 days

Number of Participants with Abnormal Urinalysis Results Reported as Adverse Events

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.

Time frame: up to approximately 102 days

Number of Participants with Clinically Significant Abnormalities in 12-Lead (ECG) Findings

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.

Time frame: up to approximately 102 days

Area Under the Concentration versus Time Curve from Time 0 to the Last Quantifiable Concentration (AUC0-last) of TERN-701 in Plasma

Blood samples will be collected to determine the AUC0-Last of TERN-701.