A Study of JNJ-64281802 in Healthy Adult Participants

• Sponsor: Janssen Research & Development, LLC (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05201937
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 6
• Anticipated Duration (Months): 10
• Patients Per Site Per Month: 4.8

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the pharmacokinetics (PK) of JNJ-64281802 in healthy participants when administered in different multiple dose regimens and as different dose strengths.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: JNJ-64281802	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 48 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A Phase 1, Open-Label Study in Healthy Adult Participants to Assess the Pharmacokinetics of JNJ-64281802 Administered as Different Multiple Dose Regimens
• Actual Study Start Date: Feb 23, 2022
• Anticipated Primary Completion Date: Dec 24, 2022
• Anticipated Study Completion Date: Dec 24, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A: Panel 1 (JNJ-64281802 High Dose Regimen) Participants will receive Loading Dose (LD) 1 of JNJ-64281802 twice daily on Days 1 and 2 followed by maintenance Dose (MD) 1 of JNJ-64281802 once daily on Days 3, 10, 17 and 24.	Drug: JNJ-64281802; JNJ-64281802 tablets will be administered orally as per the defined regimens.
Experimental: Arm A: Panel 2 (JNJ-64281802 High Dose Regimen) Participants will receive LD 1 of JNJ-64281802 twice daily on Days 1 and 2 followed by MD 2 of JNJ-64281802 once daily on Days 3, 6, 10, 13, 17, 20, 24, and 27.	Drug: JNJ-64281802; JNJ-64281802 tablets will be administered orally as per the defined regimens.
Experimental: Arm B: Panel 3 (JNJ-64281802 Low Dose Regimen) Participants will receive LD 2 of JNJ-64281802 twice daily on Days 1 and 2 followed by MD 3 of JNJ-64281802 once daily on Days 3, 10, 17 and 24.	Drug: JNJ-64281802; JNJ-64281802 tablets will be administered orally as per the defined regimens.
Experimental: Arm B: Panel 4 (JNJ-64281802 Low Dose Regimen) Participants will receive LD 2 of JNJ-64281802 twice daily on Days 1 and 2 followed by MD 4 of JNJ-64281802 once daily on Days 3, 6, 10, 13, 17, 20, 24, and 27.	Drug: JNJ-64281802; JNJ-64281802 tablets will be administered orally as per the defined regimens.
Experimental: Arm C: Panel 5 (JNJ-64281802 [Optional]) Participants dosing regimen(s) will be determined based on the results of Study Arm A and Study Arm B.	Drug: JNJ-64281802; JNJ-64281802 tablets will be administered orally as per the defined regimens.
Experimental: Arm C: Panel 6 (JNJ-64281802 [Optional]) Participants dosing regimen(s) will be determined based on the results of Study Arm A and Study Arm B.	Drug: JNJ-64281802; JNJ-64281802 tablets will be administered orally as per the defined regimens.

Outcome Measures

Primary Outcome Measures

1. Maximum Observed Plasma Concentration (Cmax) of JNJ-64281802 [Up to Day 62]

   Cmax is defined as maximum observed plasma concentration of JNJ-64281802.

2. Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-64281802 [Up to Day 62]

   Tmax is defined the actual sampling time to reach the maximum observed plasma concentration of JNJ-64281802.

3. Observed Plasma Concentration of JNJ-64281802 Just Prior to the Beginning of a Dosing Interval (Ctrough) [Up to Day 62]

   Ctrough is defined as observed plasma concentration of JNJ-64281802 just prior to the beginning of a dosing interval.

4. Apparent Terminal Elimination Half-life (t1/2) of JNJ-64281802 [Up to Day 62]

   t1/2 is defined as apparent terminal elimination half-life of JNJ-64281802.

5. Area Under the Curve From Time Zero to Last Measurable Concentration (AUC[0-last]) of JNJ-64281802 [Up to Day 62]

   AUC(0-last) is defined as area under the curve from time 0 to the time of the last measurable concentration of JNJ-64281802.

6. Area Under the Curve From Time Zero to Infinity (AUC[0-inf]) of JNJ-64281802 [Up to Day 62]

   AUC(0-inf) is defined as area under the curve of JNJ-64281802 from time 0 to infinity time.

7. Area Under the Curve From Time Zero to tau (AUC[0-tau]) of JNJ-64281802 [Up to Day 62]

   AUC(0-tau) is defined as area under the curve from time 0 to tau hours post dose of JNJ-64281802.

8. Total Apparent Oral Clearance (CL/F) of JNJ-64281802 [Up to Day 62]

   CL/F is defined as total apparent oral clearance of JNJ-64281802.

Secondary Outcome Measures

1. Number of Participants with Adverse Events (AEs) [Up to 62 days]

   An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

2. Number of Participants with Abnormalities in 12-lead Electrocardiograms (ECGs) [Up to 62 days]

   Number of participants with abnormalities in 12-lead ECGs will be reported.

3. Number of Participants with Abnormalities in Physical Examinations [Up to 62 days]

   Number of participants with abnormalities in physical examinations (including skin examination, height and body weight) will be reported.

4. Number of Participants with Abnormalities in Vital Sign Measurements [Up to 62 days]

   Number of participants with abnormalities in vital sign measurements (including temperature, temporal artery measurements, pulse/heart rate and blood pressure) will be reported.

5. Number of Participants with Abnormalities in Clinical Laboratory Tests [Up to 62 days]

   Number of participants with abnormalities in clinical laboratory tests (including hematology, serum chemistry and urinalysis) will be reported.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy on the basis of physical examination, medical history (at screening only), and vital signs performed at screening and Day -1. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities to be not clinically significant or to be appropriate and reasonable for the population under study

• Body weight not less than 50 kilogram (kg) and body mass index (BMI) within the range 18.0 and 30.0 kilogram per meter square (kg/m^2), extremes included, at screening and Day -1

• All women must have a negative highly sensitive serum (beta human chorionic gonadotropin [beta hCG]) at screening and a negative urine pregnancy test at Day -1

• Contraceptive use should be consistent with local regulations regarding the use of contraceptive methods for participant participating in clinical studies

• Must sign an informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study, before starting any screening activities

Exclusion Criteria:

• Any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, and urticaria

• Known allergies, hypersensitivity, or intolerance to JNJ-64281802 or its excipients

• Has been dosed with JNJ-64281802 in past 3 months

• Current human immunodeficiency virus type 1 (HIV-1) or type 2 (HIV-2) infection (confirmed by antibodies) at screening

• Current Coronavirus disease 2019 (COVID-19) infection (confirmed by severe acute respiratory syndrome coronavirus 2 [SARS-CoV2] polymerase chain reaction [PCR]) at the time of admission to the study site (Day -1)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini	Groningen		Netherlands	9728 NZ

Sponsors and Collaborators

• Janssen Research & Development, LLC

Investigators

• Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Janssen Research & Development, LLC
• ClinicalTrials.gov Identifier: NCT05201937
• Other Study ID Numbers: CR109139; 2021-005574-25; 64281802DNG1008
• First Posted: Jan 21, 2022
• Last Update Posted: Aug 3, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 3, 2022