A Study of JNJ-64251330 in Healthy Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-02

Study Completion Date

2020-12-29

Brief Summary

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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).

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Part 1: Treatment A (JNJ-64251330)

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

Group Type EXPERIMENTAL

JNJ-64251330

Intervention Type DRUG

JNJ-64251330 tablet will be administered orally.

Part 1: Treatment B (JNJ-64251330)

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

Group Type EXPERIMENTAL

JNJ-64251330

Intervention Type DRUG

JNJ-64251330 tablet will be administered orally.

Part 1: Treatment C (JNJ-64251330)

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

Group Type EXPERIMENTAL

JNJ-64251330

Intervention Type DRUG

JNJ-64251330 tablet will be administered orally.

Part 1: Treatment D (JNJ-64251330)

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

Group Type ACTIVE_COMPARATOR

Tofacitinib

Intervention Type DRUG

Tofacitinib tablets will be administered orally.

Part 2: Treatment EF (JNJ-64251330)

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.

Group Type EXPERIMENTAL

JNJ-64251330

Intervention Type DRUG

JNJ-64251330 tablet will be administered orally.

Part 2: Treatment FE (JNJ-64251330)

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.

Group Type EXPERIMENTAL

JNJ-64251330

Intervention Type DRUG

JNJ-64251330 tablet will be administered orally.

Interventions

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JNJ-64251330

JNJ-64251330 tablet will be administered orally.

Intervention Type DRUG

Tofacitinib

Tofacitinib tablets will be administered orally.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes