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A Study to Evaluate the Safety and Tolerability of JNJ-67670187 in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03723746
Recruitment Status : Completed
First Posted : October 30, 2018
Last Update Posted : February 19, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
The purpose of this study is to assess the safety and tolerability of single and multiple day dose of JNJ-67670187 compared to placebo.

Condition or disease Intervention/treatment Phase
Healthy Biological: JNJ-67670187 Biological: Placebo Phase 1

Detailed Description:
This study will be a Phase 1 randomized double-blind, placebo controlled multi dose study in up to 144 adult healthy volunteers. The safety, tolerability and impact on the microbiome following intake of oral dose of JNJ-67670187 for up to 14 days will be evaluated.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Day Dose Study to Assess the Safety and Tolerability of JNJ-67670187 in Healthy Participants
Actual Study Start Date : October 25, 2018
Actual Primary Completion Date : December 16, 2019
Actual Study Completion Date : December 16, 2019

Arm Intervention/treatment
Experimental: Cohort 1: Dose 1 or Placebo (Part 1 - SD)
Participants will receive a single oral dose (single day [SD] Dose 1) of either JNJ-67670187 or placebo capsules after an overnight fast on Day 1 of Part 1.
Biological: JNJ-67670187
Participants in Cohorts 1, 3 and 4 will receive Dose 1 and participants in Cohorts 2, 5, 6, 7, 8 and 9 will receive Dose 2.

Biological: Placebo
Participants will receive matching placebo in all cohorts.

Experimental: Cohort 2: Dose 2 or Placebo (Part 1 - SD)
Participants will receive a single oral dose (Dose 2) of either JNJ-67670187 or placebo capsules after an overnight fast on Day 1 of Part 1.
Biological: JNJ-67670187
Participants in Cohorts 1, 3 and 4 will receive Dose 1 and participants in Cohorts 2, 5, 6, 7, 8 and 9 will receive Dose 2.

Biological: Placebo
Participants will receive matching placebo in all cohorts.

Experimental: Cohort 3: Dose 1 or Placebo (Part 2 - MD)
Participants will receive an oral dose (Multiple Day [MD] Dose 1) of either JNJ-67670187 or placebo capsules once daily for 14 days without antibiotic pretreatment after an overnight fast in Part 2.
Biological: JNJ-67670187
Participants in Cohorts 1, 3 and 4 will receive Dose 1 and participants in Cohorts 2, 5, 6, 7, 8 and 9 will receive Dose 2.

Biological: Placebo
Participants will receive matching placebo in all cohorts.

Experimental: Cohort 4:Antibiotic + Dose 1 or Placebo (Part 2 - MD)
Participants will receive pretreatment with an oral antibiotic, followed by an oral dose (Dose 1) of either JNJ-67670187 or placebo capsules once daily for 14 days after an overnight fast in Part 2.
Biological: JNJ-67670187
Participants in Cohorts 1, 3 and 4 will receive Dose 1 and participants in Cohorts 2, 5, 6, 7, 8 and 9 will receive Dose 2.

Biological: Placebo
Participants will receive matching placebo in all cohorts.

Experimental: Cohort 5: Dose 2 or Placebo (Part 2 - MD)
Participants will receive an oral dose (Dose 2) of either JNJ-67670187 or placebo capsules once daily without antibiotic pretreatment for 14 days after an overnight fast in Part 2.
Biological: JNJ-67670187
Participants in Cohorts 1, 3 and 4 will receive Dose 1 and participants in Cohorts 2, 5, 6, 7, 8 and 9 will receive Dose 2.

Biological: Placebo
Participants will receive matching placebo in all cohorts.

Experimental: Cohort 6:Antibiotic + Dose 2 or Placebo (Part 2 - MD)
Participants will receive pretreatment with an oral antibiotic, followed by an oral dose (Dose 2) of either JNJ-67670187 or placebo capsules once daily for 14 days after an overnight fast in Part 2.
Biological: JNJ-67670187
Participants in Cohorts 1, 3 and 4 will receive Dose 1 and participants in Cohorts 2, 5, 6, 7, 8 and 9 will receive Dose 2.

Biological: Placebo
Participants will receive matching placebo in all cohorts.

Experimental: Cohort 7 (Optional): Laxative + Dose 2 or Placebo (Part 3)
Participants may receive pretreatment with an oral laxative, followed by an oral dose (Dose 2) of either JNJ-67670187 or placebo capsules once daily for 14 days after an overnight fast in Part 2. Cohort 7 (Part 3) will only be conducted if the strains are not detected in microbial analysis of Parts 1 and 2.
Biological: JNJ-67670187
Participants in Cohorts 1, 3 and 4 will receive Dose 1 and participants in Cohorts 2, 5, 6, 7, 8 and 9 will receive Dose 2.

Biological: Placebo
Participants will receive matching placebo in all cohorts.

Experimental: Cohort 8 (Optional):Antibiotic+Laxative+Dose 2/Placebo(Part 3)
Participants may receive pretreatment with an oral antibiotic and oral laxative, followed by an oral dose (Dose 2) of either JNJ-67670187 or placebo capsules once daily for 14 days after an overnight fast in Part 2. Cohort 8 (Part 3) will only be conducted if the strains are not detected in microbial analysis of Parts 1 and 2.
Biological: JNJ-67670187
Participants in Cohorts 1, 3 and 4 will receive Dose 1 and participants in Cohorts 2, 5, 6, 7, 8 and 9 will receive Dose 2.

Biological: Placebo
Participants will receive matching placebo in all cohorts.

Experimental: Cohort 9 (Optional): Dose 2 or Placebo (Part 3) + Biopsy
Participants may receive an oral dose (Dose 2) of either JNJ-67670187 or placebo capsules once daily for 14 days after an overnight fast in Part 2. After final dosing collection of sigmoid biopsies will be performed. Cohort 9 (Part 3) will only be conducted if the strains are not detected in microbial analysis of Parts 1 and 2.
Biological: JNJ-67670187
Participants in Cohorts 1, 3 and 4 will receive Dose 1 and participants in Cohorts 2, 5, 6, 7, 8 and 9 will receive Dose 2.

Biological: Placebo
Participants will receive matching placebo in all cohorts.




Primary Outcome Measures :
  1. Part 1 Single Day (SD) Dose: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 3 Months post final dose or up to Day 84 ]
    An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are AEs which will occur between administration of study drug and 3 months or up to Day 84 that were absent before treatment or that worsened relative to pre-treatment state. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  2. Part 2 Multiple Day (MD) Dose : Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 3 Months post final dose or up to Day 98 ]
    An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. TEAEs are AEs which will occur between administration of study drug and 3 months or up to Day 98 that were absent before treatment or that worsened relative to pre-treatment state. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  3. Part 1 SD: Number of Participants With Abnormalities in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings as a Measure of Safety and Tolerability [ Time Frame: Predose up to Day 84 ]
    Number of participants with abnormalities in vital signs, physical examinations, ECG and clinically significant laboratory findings will be reported.

  4. Part 2 MD: Number of Participants With Abnormalities in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Clinically Significant Laboratory Findings as a Measure of Safety and Tolerability [ Time Frame: Predose up to Day 98 ]
    Number of participants with abnormalities in vital signs, physical examinations, ECG and clinically significant laboratory findings will be reported.


Secondary Outcome Measures :
  1. Detection and Abundance of JNJ‑67670187 [ Time Frame: Pre-dose, up to Day 82 (SD) and up to Day 98 (MD) ]
    Stool assessment will be done to characterize the presence of JNJ-67670187.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Have a body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m^2) inclusive, and a body weight of at least 50 kilogram (kg)
  • Be otherwise healthy on the basis of physical examination, medical history, and vital signs, and 12 lead electrocardiogram (ECG) performed at screening and at admission
  • Be otherwise healthy on the basis of clinical laboratory tests performed at screening and at admission. If the results of the serum chemistry panel, hematology, 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
  • All women of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening and a negative urine pregnancy test on day of admission
  • Must have normal bowel movements

Exclusion Criteria:

  • Has a positive serum pregnancy test at screening, a positive urine pregnancy test, or is a female still lactating prior to study intervention administration
  • An active cigarette smoker or has quit cigarette smoking within the previous 6 months
  • Has a positive urine toxicology screen at screening or at admission for substances of abuse including but not limited to cocaine, cannabinoids, amphetamines, benzodiazepines, barbiturates, opiates, tricyclic antidepressants and methadone
  • History of any clinically significant medical illness or medical disorders the investigator considers should exclude the participant, including (but not limited to), neuromuscular, hematological disease, immune deficiency state, respiratory disease, hepatic or gastrointestinal (GI) disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease
  • Has an active systemic or GI acute or chronic infection as determined by appropriate clinical screening and laboratory tests

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03723746


Locations
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Belgium
Clinical Pharmacology Unit
Merksem, Belgium, 2170
Netherlands
PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini
Groningen, Netherlands, 9728 NZ
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03723746    
Other Study ID Numbers: CR108532
2018-002287-81 ( EudraCT Number )
67670187IBD1001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: October 30, 2018    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No