Clinical trial NCT06589726: A TQT Study to Investigate the Effect of Enpatoran on Cardiac Repolarization in Healthy Participants
Official title: A Single-Dose, Randomized, Double-Blind, Placebo- and Positive-Controlled, 4-Way Crossover Study to Evaluate the Effect of Enpatoran on the QTc (Corrected QT) Interval in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
Collaborators: name: Merck KGaA, Darmstadt, Germany
First posted: 2024-09-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess potential effects of enpatoran on cardiac repolarization (i.e. prolongation of QT interval).


Eligibility criteria: Inclusion criteria:

* Participants are overtly healthy, as determined by medical evaluation, including no clinically significant abnormality identified on medical history, physical examination, vital signs, 12-lead ECG, or laboratory evaluation and no active clinically significant disorder, condition, infection, or disease that would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion
* Participants have a body weight within the range 50.0 to 100.0 kilograms (kg) (inclusive) and body mass index (BMI) within the range 19.0 to 30.0 kilograms per square meter (kg/m\^2) (inclusive)
* Other protocol defined inclusion criteria could apply

Exclusion criteria:

* History or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, musculoskeletal, genitourinary, immunological, dermatological, connective tissue, psychiatric (due to rare risk of hallucinations, agitation, and activation of psychosis), and other diseases or disorders, and epilepsy, as determined by medical evaluation
* Individuals with diagnosis of hemochromatosis, Wilson´s disease, alpha 1 antitrypsin deficiency, or any other chronic liver disease including Gilbert's disease
* Prior history of cholecystectomy or splenectomy, and any clinically relevant surgery within 6 months prior to the first administration of study intervention
* History of malignancy (e.g. hematologic, skin, solid tumor) less than or equal to (\<=) 10 years prior to Screening
* History of chronic or recurrent acute infection or any bacterial, viral, parasitic, or fungal infections within 30 days prior to Screening and at any time between Screening and admission to CRU, or hospitalization due to infection within 6 months prior to the first administration of study intervention
* History of shingles within 12 months prior to Screening
* Other protocol defined exclusion criteria could apply

Primary outcomes:
measure: Placebo-Corrected Change from Baseline in Heart Rate-Corrected QT Interval by Fridericia's Formula (QTcF) for Enpatoran
timeFrame: Pre-dose on Day 1 (baseline) up to 24 hours post-dose
Secondary outcomes:
measure: Placebo-Corrected Change from Baseline in Heart Rate-Corrected QT Interval by Fridericia's Formula (QTcF) for Moxifloxacin
timeFrame: Pre-dose on Day 1 (baseline) up to 24 hours post-dose
measure: Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Up to approximately 72 days
measure: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) by Severity
timeFrame: Up to approximately 72 days
measure: Number of Participants with Abnormal Laboratory Parameters, Vital Signs and 12-Lead Electrocardiogram (ECG) Findings
timeFrame: Up to approximately 72 days
measure: ECG Parameters: QT Interval, heart rate-corrected QT interval (QTc), individual corrected QT interval (QTcI), PR Interval, QRS interval and RR Interval
timeFrame: Pre-dose up to 24 hours post-dose
measure: ECG Parameter: Heart Rate (HR)
timeFrame: Pre-dose up to 24 hours post-dose
measure: Number of Participants with T-wave Morphology Changes and U-wave Presence
timeFrame: Pre-dose up to 24 hours post-dose
measure: Pharmacokinetic (PK) Plasma Concentrations of Enpatoran
timeFrame: Pre-dose up to 24 hours post-dose
measure: Pharmacokinetic (PK) Plasma Concentrations of Moxifloxacin
timeFrame: Pre-dose up to 24 hours post-dose
Other outcomes:
Locations:
city: Neu-Ulm
country: Germany
facility: Nuvisan GmbH
Study officials:
affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: