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Completed

NCT Number: NCT06589726

A TQT Study to Investigate the Effect of Enpatoran on Cardiac Repolarization in Healthy Participants

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

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nuvisan GmbH

Neu-Ulm, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Participants will receive a single oral dose of placebo matched to enpatoran in either of treatment period 1, 2, 3 and 4.

moxifloxacin

Drug

Participants will receive a single oral dose of moxifloxacin tablet (Treatment B) in either of treatment period 1, 2, 3 and 4.

Enpatoran low dose

Drug

Participants will receive a single oral low dose of enpatoran tablet (Treatment C) in either of treatment period 1, 2, 3 and 4.

Other names: M5049

Enpatoran high dose

Drug

Participants will receive a single oral high dose of enpatoran tablet (Treatment D) in either of treatment period 1, 2, 3 and 4.

Other names: M5049

Primary outcomes

  1. Placebo-Corrected Change from Baseline in Heart Rate-Corrected QT Interval by Fridericia's Formula (QTcF) for Enpatoran

    Time frame: Pre-dose on Day 1 (baseline) up to 24 hours post-dose

Secondary outcomes

  1. Placebo-Corrected Change from Baseline in Heart Rate-Corrected QT Interval by Fridericia's Formula (QTcF) for Moxifloxacin

    Time frame: Pre-dose on Day 1 (baseline) up to 24 hours post-dose

  2. Number of Participants with Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Up to approximately 72 days

  3. Number of Participants with Treatment-Emergent Adverse Events (TEAEs) by Severity

    Time frame: Up to approximately 72 days

  4. Number of Participants with Abnormal Laboratory Parameters, Vital Signs and 12-Lead Electrocardiogram (ECG) Findings

    Time frame: Up to approximately 72 days

  5. ECG Parameters: QT Interval, heart rate-corrected QT interval (QTc), individual corrected QT interval (QTcI), PR Interval, QRS interval and RR Interval

    Time frame: Pre-dose up to 24 hours post-dose

  6. ECG Parameter: Heart Rate (HR)

    Time frame: Pre-dose up to 24 hours post-dose

  7. Number of Participants with T-wave Morphology Changes and U-wave Presence

    Time frame: Pre-dose up to 24 hours post-dose

  8. Pharmacokinetic (PK) Plasma Concentrations of Enpatoran

    Time frame: Pre-dose up to 24 hours post-dose

  9. Pharmacokinetic (PK) Plasma Concentrations of Moxifloxacin

    Time frame: Pre-dose up to 24 hours post-dose

Sponsors and collaborators

Lead sponsor

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Industry

Collaborators

  • Merck KGaA, Darmstadt, Germany

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Dec 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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