A Study of JNJ-64251330 in Healthy Participants

Sponsor
Janssen Research & Development, LLC
Study ID
NCT04552197
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • JNJ-64251330 — DRUG
    JNJ-64251330 tablet will be administered orally.
  • Tofacitinib — DRUG
    Tofacitinib tablets will be administered orally.

Study Details

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).

Key Dates

Start date
Sep 2, 2020
Status verified
Dec 2022
Primary completion
Dec 29, 2020
Completion
Dec 29, 2020

Study Design

Enrollment
36 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Part 1: Treatment A (JNJ-64251330)
    Participants will receive JNJ-64251330 (dose 1), once daily for 5 days under fasting conditions.
  • Experimental: Part 1: Treatment B (JNJ-64251330)
    Participants will receive JNJ-64251330 (dose 1), twice daily for 5 days under fasting conditions.
  • Experimental: Part 1: Treatment C (JNJ-64251330)
    Participants will receive JNJ-64251330 (dose 2), twice daily for 5 days under fasting conditions.
  • Active Comparator: Part 1: Treatment D (JNJ-64251330)
    Participants will receive tofacitinib tablet twice daily for 5 days under fasting conditions.
  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

Part 1: Maximum Observed Plasma Concentrations (Cmax) of JNJ-64251330 [ Time Frame: Predose, 0.25 hour (h), 0.5 h, 1 h, 2 h, 4 h, 6 h, 8 h, 12 h Postdose on Day 1 and Day 5; Predose on Day 2 ]

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