A Study of JNJ-64251330 in Healthy Participants

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: JNJ-64251330; Drug: Tofacitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT04552197

64251330EDI1003 (Other Identifier)

CR108808

2020-000167-24 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to evaluate: systemic and local gut (rectum and sigmoid colon) exposure to JNJ-64251330, local tissue Pharmacodynamics (PD) using gut (rectum and sigmoid colon) biopsies (Part 1) and the effect of food on the rate and extent of absorption of JNJ-64251330 from oral tablet dosed with or without food (Part 2).

Enrollment: 36 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body mass index (BMI; weight [kilogram {kg}]/height^2 [meter {m}]^2) between 18.0 and 30.0 kilograms per meter square (kg/m^2) (inclusive), and body weight not less than 50.0 kg
• 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function, including: QTc interval less than or equal to (<=) 450 milliseconds (ms) for men and <= 470 ms for women
• Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, lipid panel, hematology, coagulation 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
• Have participant-reported normal consistency, regular bowel movements
• A woman must have a negative highly sensitive serum (beta-human chorionic gonadotropin [hCG])

Exclusion criteria

• History of hepatic or renal insufficiency; significant cardiac, vascular, pulmonary, endocrine, hematologic, rheumatologic, neurologic, oncologic, or psychiatric disease, or metabolic disturbances or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
• Active or chronic infection, a nontuberculous mycobacterial infection, or opportunistic infection (example, pneumocystosis and aspergillosis)
• History of severe allergic reaction to midazolam
• Contraindications to the use of tofacitinib per summary of product characteristics (SmPC)^14/ local prescribing information
• Female participant who is a breastfeeding mother

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 6 patient groups

Part 1: Treatment A (JNJ-64251330)

Experimental group

Description:

Participants will receive JNJ-64251330 (dose 1), once daily for 5 days under fasting conditions.

Treatment:

Drug: JNJ-64251330

Part 1: Treatment B (JNJ-64251330)

Experimental group

Description:

Participants will receive JNJ-64251330 (dose 1), twice daily for 5 days under fasting conditions.

Treatment:

Drug: JNJ-64251330

Part 1: Treatment C (JNJ-64251330)

Experimental group

Description:

Participants will receive JNJ-64251330 (dose 2), twice daily for 5 days under fasting conditions.

Treatment:

Drug: JNJ-64251330

Part 1: Treatment D (JNJ-64251330)

Active Comparator group

Description:

Participants will receive tofacitinib tablet twice daily for 5 days under fasting conditions.

Treatment:

Drug: Tofacitinib

Part 2: Treatment EF (JNJ-64251330)

Experimental group

Description:

Participants will receive a single dose of JNJ-64251330 (dose 2), on Day 1 once under fasting conditions (Treatment E) in Period 1 followed by a single dose of JNJ-64251330 (dose 2), on Day 1 once with high fat breakfast (Treatment F) in Period 2. There will be a minimum of 5 days washout between dosing in the two treatment periods.

Treatment:

Drug: JNJ-64251330

Part 2: Treatment FE (JNJ-64251330)

Experimental group

Description:

Participants will receive a single dose of JNJ-64251330 (dose 2), on Day 1 once with high fat breakfast (Treatment F) in Period 1 followed by a single dose of JNJ-64251330 (dose 2), on Day 1 once under fasting conditions (Treatment E) in Period 2. There will be a minimum of 5 days washout between dosing in the two treatment periods.

Treatment:

Drug: JNJ-64251330