A Study of JNJ-70033093 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: JNJ-70033093

• Registration Number: NCT04448964
• Lead Sponsor: Janssen Research & Development, LLC

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics (PK) and relative bioavailability of a single dose of JNJ-70033093 spray dried dispersion (SDD) tablets compared with JNJ-70033093 SDD granule capsules in healthy participants under fasting conditions in Part 1 and 2 and to assess the effect of food on the bioavailability of a single dose of JNJ-70033093 SDD tablets in Part 1.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-25
• Study First Submitted QC: 2020-06-25
• Study Start: 2020-06-26
• Study First Posted: 2020-06-26
• Primary Completion: 2020-11-14
• Study Completion: 2020-11-14
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and on Day -1 of Treatment Period 1. If there are abnormalities, the investigator may decide that the abnormalities or deviations from normal are not clinically significant, in which case the participant may be included
• Healthy on the basis of safety laboratory tests performed at screening and on Day -1 of Period 1. If the results of the safety laboratory tests 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
• If a woman, must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening and urine pregnancy test on Day 1 of each treatment period
• Body mass index (BMI) between 18.0 and 30.0 kilogram per meter square (kg/m^2, inclusive (BMI = weight/height^2), and body weight not less than 50 kg at screening
• After being supine for 5 minutes, systolic blood pressure between 90 and 140 millimeter of Mercury (mmHg), inclusive; and no higher than 90 mmHg diastolic blood pressure at screening and on Day -1 of Treatment Period 1
• Must sign an ICF indicating that they understand the purpose of, and procedures required for the study and is willing to participate in the study
• Before randomization, a woman must be either: a.) Not of childbearing potential (Postmenopausal- no menses for 12 months without an alternative medical cause and Permanently sterile- include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy); b.) of childbearing potential and practicing a highly effective method of contraception for at least 3 months prior to the study entry and agrees to remain on a highly effective method of contraception throughout the study and for at least 34 days after the last dose of study drug
• During the study, a man who is sexually active with a woman of childbearing potential or with a woman who is pregnant must agree to use a barrier method of contraception

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Exclusion Criteria

• History of any known illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant or that could prevent, limit or confound the protocol specified assessments.
• History of any clinically significant drug or food allergies (such as anaphylaxis or hepatotoxicity) and known allergy to the study drugs or any of the excipients of the formulation
• History of allergy to or unwillingness to consume any component of the standardized high-fat breakfast menu to be provided in this study
• Use of any systemic strong cytochrome P450 P glycoprotein ([CYP] 3A4/P-gp) inducers (example, [rifampin]) or inhibitors (example, [itraconazole]) within 4 weeks before the first dose of the study drug
• Participants with current hepatitis B infection (confirmed by hepatitis B surface antigen [HBsAg]), or hepatitis C infection (confirmed by hepatitis C virus [HCV] antibody), or human immunodeficiency virus type 1 (HIV-1) or human immunodeficiency virus type 2 (HIV-2) infection at study screening
• Clinically significant abnormal values for hematology, coagulation, clinical chemistry or urinalysis at screening or on Day -1 of Treatment Period 1 as determined by the investigator or appropriate designee
• Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for hormonal contraceptives, hormone replacement therapy and paracetamol (acetaminophen) within 14 days before the first dose of the study drug until completion of the study
• Any of the following on a 12-lead electrocardiogram (ECG) and the assessment of QT interval, confirmed by repeat at screening and Day -1 of Treatment Period 1: a.) Heart rate greater than (>) 100 beats per minute (bpm); b.) PR > 210 milliseconds (ms); c.) QRS > 120 ms; d.) QT corrected according to Fridericia's formula (QTcF) > 450 ms for male and > 470 ms for female

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Part 1: Treatment Sequence CAB	JNJ-70033093	Participants will receive Treatment C in Treatment Period 1, followed by Treatment A in Treatment Period 2, and then Treatment B in Treatment Period 3 on Day 1 of each Period during Part 1. There will be a wash-out period of at least 5 days and up to 2 weeks between Day 1 of each treatment period.
Part 1: Treatment Sequence BAC	JNJ-70033093	Participants will receive Treatment B in Treatment Period 1, followed by Treatment A in Treatment Period 2, and then Treatment C in Treatment Period 3 on Day 1 of each Period during Part 1. There will be a wash-out period of at least 5 days and up to 2 weeks between Day 1 of each treatment period.
Part 1: Treatment Sequence ABC	JNJ-70033093	Participants will receive a single dose of JNJ-70033093 spray-dried dispersion (SDD) tablet under fasted conditions (Treatment A) in Treatment Period 1, followed by JNJ-70033093 SDD tablet in fed conditions (Treatment B) in Treatment Period 2, and then JNJ-70033093 SDD granule capsule under fasted conditions (Treatment C) in Treatment Period 3 on Day 1 of each Period during Part 1. There will be a wash-out period of at least 5 days and up to 2 weeks between Day 1 of each treatment period.
Part 1: Treatment Sequence BCA	JNJ-70033093	Participants will receive Treatment B in Treatment Period 1, followed by Treatment C in Treatment Period 2, and then Treatment A in Treatment Period 3 on Day 1 of each Period during Part 1. There will be a wash-out period of at least 5 days and up to 2 weeks between Day 1 of each treatment period.
Part 1: Treatment Sequence ACB	JNJ-70033093	Participants will receive Treatment A in Treatment Period 1, followed by Treatment C in Treatment Period 2, and then Treatment B in Treatment Period 3 on Day 1 of each Period during Part 1. There will be a wash-out period of at least 5 days and up to 2 weeks between Day 1 of each treatment period.
Part 1: Treatment Sequence CBA	JNJ-70033093	Participants will receive Treatment C in Treatment Period 1, followed by Treatment B in Treatment Period 2, and then Treatment A in Treatment Period 3 on Day 1 of each Period during Part 1. There will be a wash-out period of at least 5 days and up to 2 weeks between Day 1 of each treatment period.
Part 2: Treatment Sequence DE	JNJ-70033093	Participants will receive Treatment D (single dose of JNJ-70033093 SDD tablet in fed conditions) in Treatment Period 1, and then Treatment E (single dose of JNJ-70033093 SDD granule capsule under fasted conditions) in Treatment Period 2 on Day 1 of each Period during Part 2. There will be a wash-out period of at least 5 days and up to 2 weeks between Day 1 of each treatment period.
Part 2: Treatment Sequence ED	JNJ-70033093	Participants will receive Treatment E in Treatment Period 1, and then Treatment D in Treatment Period 2 on Day 1 of each Period during Part 2. There will be a wash-out period of at least 5 days and up to 2 weeks between Day 1 of each treatment period.

Primary Outcome Measures

Name	Time	Method
Part 1 and 2: Apparent Elimination Half-life (t1/2) of JNJ-70033093	Up to 72 hours post dose	Apparent elimination half-life associated with the terminal slope lambda(z) of the semilogarithmic drug concentration-time curve.
Part 1 and 2: Maximum Observed Plasma Concentration (Cmax) of JNJ-70033093	Up to 72 hours post dose	Cmax is defined as maximum observed plasma concentration after administration of JNJ-70033093.
Part 1 and 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-70033093	Up to 72 hours post dose	Tmax is defined time to reach the maximum observed plasma concentration.
Part 1 and 2: Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC [0-last]) of JNJ-70033093	Up to 72 hours post dose	AUC (0-last) is defined as area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration after administration of JNJ-70033093.
Part 1 and 2: Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUC [0-inf]) of JNJ-70033093	Up to 72 hours post dose	AUC (0-inf) is defined as area under the plasma concentration-time curve from time 0 to infinity after administration of JNJ-70033093.

Secondary Outcome Measures

Name	Time	Method
Part 1 and 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability	Up to 2 Months	An AE is any untoward medical occurrence in a clinical study participant administered a investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment.
Part 1 and 2: Number of Participants with Clinically Significant Changes in Physical Examination	Up to 2 Months	Number of participants with clinically significant changes in physical examination including height and body weight will be reported.
Part 1 and 2: Number of Participants with Clinically Significant Changes in Vital Signs	Up to 2 Months	Number of participants with clinically significant changes in vital signs including temperature (axillary), pulse rate, respiratory rate, blood pressure will be reported.
Part 1 and 2: Number of Participants with Abnormalities in Electrocardiogram (ECG)	Up to 2 Months	Number of participants with abnormalities in ECG will be reported.

Trial Locations

Locations (1)

Clinical Pharmacology Unit; 🇧🇪 Merksem, Belgium