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Completed

NCT Number: NCT03607513

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-64264681 in Healthy Male and Female Participants

The primary purpose of this study is to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of JNJ-64264681 in healthy participants after single and multiple oral doses.

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Key information

Conditions

Healthy

Age range

18 year–58 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Pharmacology Unit

Merksem, 2170, Belgium

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Participant must have a body mass index (BMI) between 18.0 and 30.0 kilogram per meter square (kg/m^2) (BMI = weight[kg]/height[m]^2), and a body weight of not less than 50 kilogram (kg)
  • Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12-lead Electrocardiogram (ECG) performed at screening and Day -1
  • Participant must be healthy on the basis of clinical laboratory tests performed at screening and Day -1. If the results of the serum chemistry panel, coagulation, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator
  • Participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
  • Female participants must not be of childbearing potential by fulfilling 1 of the criteria below: a) Be over 45 years of age with no menses for 12 months without an alternative medical cause, with screening follicle stimulating hormone (FSH) levels of greater than (>)40 International Units Per Liter (IU/L) or milli-international units per milliliter (mIU/mL). b) Be permanently surgically sterile. Permanent surgical sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy. Documentation of FSH levels is not required in the case of surgical sterility

Exclusion criteria

  • Participant has current, or history of clinically significant medical illness including, but not limited to, liver or renal insufficiency, significant cardiac (including heart valve disease), vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
  • Participant has a history of abnormal bleeding or bruising
  • Participant has a history of atrial fibrillation or history of arrhythmias
  • Participant has history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence)
  • Participant has known allergies, hypersensitivity, or intolerance to polyethylene glycol 400 (PEG400) (vehicle for JNJ-64264681 for oral solution dosing) for participant in a cohort where study drug is to be dosed as an oral solution, or to microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, silica dioxide, sodium lauryl sulfate, magnesium stearate, or gelatin (excipients in the solid dose formulation (capsule) of JNJ-64264681) for participant in a solid dose formulation cohort

Treatment and study plan

JNJ-64264681

Drug

For all cohorts except the solid dose formulation cohort, JNJ-64264681 wlll be administered as oral solution. For the solid dose formulation cohort, JNJ-64264681 will be provided as capsules for oral administration.

Placebo

Drug

Matching placebo to JNJ-64264681 will be administered as oral solution.

Primary outcomes

  1. Single Ascending Dose (SAD): Number of Participants with Adverse Events

    Time frame: Up to Day 14

    An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

  2. Multiple Ascending Dose (MAD): Number of Participants with Adverse Events

    Time frame: Up to Day 24

    An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

  3. SAD: Maximum Observed Plasma Concentration (Cmax)

    Time frame: Up to Day 4

    Cmax is the maximum observed plasma JNJ-64264681 concentration.

  4. MAD: Maximum Observed Plasma Concentration (Cmax)

    Time frame: Up to Day 13

    Cmax is the maximum observed plasma JNJ-64264681 concentration.

  5. SAD: Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: Up to Day 4

    Tmax is defined as actual sampling time to reach maximum observed concentration.

  6. MAD: Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: Up to Day 13

    Tmax is defined as actual sampling time to reach maximum observed concentration.

  7. SAD: Time to Last Quantifiable Plasma Concentration (Tlast)

    Time frame: Up to Day 4

    The Tlast is the time to last observed quantifiable plasma concentration.

  8. MAD: Time to Last Quantifiable Plasma Concentration (Tlast)

    Time frame: Up to Day 13

    The Tlast is the time to last observed quantifiable plasma concentration.

  9. SAD: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24])

    Time frame: Day 1: Up to 24 hours post-dose

    AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours.

  10. MAD: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours (AUC[0-24])

    Time frame: Day 1: Up to 24 hours post-dose

    AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours.

  11. SAD: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Observed Quantifiable Concentration (AUClast)

    Time frame: Up to Day 4

    AUClast is defined as area under the plasma JNJ-64264681 concentration-time curve from time 0 to time of the last observed quantifiable concentration.

  12. MAD: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)

    Time frame: Day 10

    AUCtau is area under the plasma JNJ-64264681 concentration-time curve during a dosing interval (tau) at steady-state.

  13. SAD: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])

    Time frame: Up to Day 3

    The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.

  14. SAD: Apparent Elimination Half-life (t1/2)

    Time frame: Up to Day 3

    t1/2 is apparent elimination half-life of JNJ-64264681 associated with the terminal slope (z) of the semi-logarithmic drug concentration-time curve.

  15. MAD: Apparent Elimination Half-life (t1/2)

    Time frame: Up to Day 13

    t1/2 is apparent elimination half-life of JNJ-64264681 associated with the terminal slope (z) of the semi-logarithmic drug concentration-time curve.

  16. MAD: Accumulation Ratio

    Time frame: Up to Day 13

    MAD: Accumulation Ratio obtained by dividing AUC of JNJ-64264681 at two different time points.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

A Double-blind, Placebo-controlled, Randomized, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-64264681 in Healthy Male and Female Subjects

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 31, 2018
Registry last updated
Feb 3, 2025

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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