HealthyPhase 1NCT03723746
A Study to Evaluate the Safety and Tolerability of JNJ-67670187 in Healthy Participants
A Phase 1 study testing JNJ-67670187 in people with Healthy, run by Janssen Research & Development, LLC at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- JNJ-67670187
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 25 Oct 2018to 16 Dec 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Netherlands1 site
PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini
Groningen, 9728 NZ
About this study
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
The purpose of this study is to assess the safety and tolerability of single and multiple day dose of JNJ-67670187 compared to placebo.
Read the 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.
- Conditions
- Healthy
- Being tested
- JNJ-67670187, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-67670187Biological
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.
PlaceboBiological
Participants will receive matching placebo in all cohorts.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Dose 1 or Placebo (Part 1 - SD) | Experimental | 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. Receives: Biological: JNJ-67670187; Biological: Placebo |
| Cohort 2: Dose 2 or Placebo (Part 1 - SD) | Experimental | 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. Receives: Biological: JNJ-67670187; Biological: Placebo |
| Cohort 3: Dose 1 or Placebo (Part 2 - MD) | Experimental | 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. Receives: Biological: JNJ-67670187; Biological: Placebo |
| Cohort 4:Antibiotic + Dose 1 or Placebo (Part 2 - MD) | Experimental | 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. Receives: Biological: JNJ-67670187; Biological: Placebo |
| Cohort 5: Dose 2 or Placebo (Part 2 - MD) | Experimental | 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. Receives: Biological: JNJ-67670187; Biological: Placebo |
| Cohort 6:Antibiotic + Dose 2 or Placebo (Part 2 - MD) | Experimental | 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. Receives: Biological: JNJ-67670187; Biological: Placebo |
| Cohort 7 (Optional): Laxative + Dose 2 or Placebo (Part 3) | Experimental | 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. Receives: Biological: JNJ-67670187; Biological: Placebo |
| Cohort 8 (Optional):Antibiotic+Laxative+Dose 2/Placebo(Part 3) | Experimental | 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. Receives: Biological: JNJ-67670187; Biological: Placebo |
| Cohort 9 (Optional): Dose 2 or Placebo (Part 3) + Biopsy | Experimental | 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. Receives: Biological: JNJ-67670187; Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: 3 Months post final dose or up to Day 84
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
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.
Measured: 3 Months post final dose or up to Day 98
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
Number of participants with abnormalities in vital signs, physical examinations, ECG and clinically significant laboratory findings will be reported.
Measured: Predose up to Day 84
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
Number of participants with abnormalities in vital signs, physical examinations, ECG and clinically significant laboratory findings will be reported.
Measured: Predose up to Day 98
Secondary outcomes (1)
Detection and Abundance of JNJ-67670187
Stool assessment will be done to characterize the presence of JNJ-67670187.
Measured: Pre-dose, up to Day 82 (SD) and up to Day 98 (MD)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start25 Oct 2018
- Primary completion16 Dec 2019
- Study completion16 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03723746
- Sponsor's protocol ID
- CR108532
- Other IDs
- 2018-002287-81, 67670187IBD1001, 2018
- Status last verified
- Feb 2020
- First submitted
- 26 Oct 2018
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03723746
- Acronym / sponsor ID
- CR108532
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2018 (actual)
- Primary completion
- 16 Dec 2019 (actual)
- Study completion
- 16 Dec 2019 (actual)
- First posted
- 30 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Dose 1 or Placebo (Part 1 - SD) | Experimental | Biological: JNJ-67670187, Biological: PlaceboParticipants 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. |
| Cohort 2: Dose 2 or Placebo (Part 1 - SD) | Experimental | Biological: JNJ-67670187, Biological: PlaceboParticipants 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. |
| Cohort 3: Dose 1 or Placebo (Part 2 - MD) | Experimental | Biological: JNJ-67670187, Biological: PlaceboParticipants 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. |
| Cohort 4:Antibiotic + Dose 1 or Placebo (Part 2 - MD) | Experimental | Biological: JNJ-67670187, Biological: PlaceboParticipants 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. |
| Cohort 5: Dose 2 or Placebo (Part 2 - MD) | Experimental | Biological: JNJ-67670187, Biological: PlaceboParticipants 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. |
| Cohort 6:Antibiotic + Dose 2 or Placebo (Part 2 - MD) | Experimental | Biological: JNJ-67670187, Biological: PlaceboParticipants 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. |
| Cohort 7 (Optional): Laxative + Dose 2 or Placebo (Part 3) | Experimental | Biological: JNJ-67670187, Biological: PlaceboParticipants 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. |
| Cohort 8 (Optional):Antibiotic+Laxative+Dose 2/Placebo(Part 3) | Experimental | Biological: JNJ-67670187, Biological: PlaceboParticipants 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. |
| Cohort 9 (Optional): Dose 2 or Placebo (Part 3) + Biopsy | Experimental | Biological: JNJ-67670187, Biological: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-67670187Participants 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 | Cohort 1: Dose 1 or Placebo (Part 1 - SD), Cohort 2: Dose 2 or Placebo (Part 1 - SD), Cohort 3: Dose 1 or Placebo (Part 2 - MD), Cohort 4:Antibiotic + Dose 1 or Placebo (Part 2 - MD), Cohort 5: Dose 2 or Placebo (Part 2 - MD), Cohort 6:Antibiotic + Dose 2 or Placebo (Part 2 - MD), Cohort 7 (Optional): Laxative + Dose 2 or Placebo (Part 3), Cohort 8 (Optional):Antibiotic+Laxative+Dose 2/Placebo(Part 3), Cohort 9 (Optional): Dose 2 or Placebo (Part 3) + Biopsy |
| PlaceboParticipants will receive matching placebo in all cohorts. | Biological | Cohort 1: Dose 1 or Placebo (Part 1 - SD), Cohort 2: Dose 2 or Placebo (Part 1 - SD), Cohort 3: Dose 1 or Placebo (Part 2 - MD), Cohort 4:Antibiotic + Dose 1 or Placebo (Part 2 - MD), Cohort 5: Dose 2 or Placebo (Part 2 - MD), Cohort 6:Antibiotic + Dose 2 or Placebo (Part 2 - MD), Cohort 7 (Optional): Laxative + Dose 2 or Placebo (Part 3), Cohort 8 (Optional):Antibiotic+Laxative+Dose 2/Placebo(Part 3), Cohort 9 (Optional): Dose 2 or Placebo (Part 3) + Biopsy |
Primary outcome
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.
1 secondary outcome
Detection and Abundance of JNJ-67670187
Time frame: Pre-dose, up to Day 82 (SD) and up to Day 98 (MD)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-67670187 in people with Healthy, run by Janssen Research & Development, LLC at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2020.