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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

Tracking Information
First Submitted Date  ICMJE October 26, 2018
First Posted Date  ICMJE October 30, 2018
Last Update Posted Date February 19, 2020
Actual Study Start Date  ICMJE October 25, 2018
Actual Primary Completion Date December 16, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2018)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety and Tolerability of JNJ-67670187 in Healthy Participants
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Biological: JNJ-67670187
    • Biological: Placebo
  • 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.
    Interventions:
    • Biological: JNJ-67670187
    • Biological: Placebo
  • 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.
    Interventions:
    • Biological: JNJ-67670187
    • Biological: Placebo
  • 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.
    Interventions:
    • Biological: JNJ-67670187
    • Biological: Placebo
  • 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.
    Interventions:
    • Biological: JNJ-67670187
    • Biological: Placebo
  • 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.
    Interventions:
    • Biological: JNJ-67670187
    • Biological: Placebo
  • 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.
    Interventions:
    • Biological: JNJ-67670187
    • Biological: Placebo
  • 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.
    Interventions:
    • Biological: JNJ-67670187
    • Biological: Placebo
  • 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.
    Interventions:
    • Biological: JNJ-67670187
    • Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 5, 2019)
74
Original Estimated Enrollment  ICMJE
 (submitted: October 26, 2018)
144
Actual Study Completion Date  ICMJE December 16, 2019
Actual Primary Completion Date December 16, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03723746
Other Study ID Numbers  ICMJE CR108532
2018-002287-81 ( EudraCT Number )
67670187IBD1001 ( Other Identifier: Janssen Research & Development, LLC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Janssen Research & Development, LLC
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Janssen Research & Development, LLC
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP