HealthyPhase 1NCT03139500
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-61803534 and to Evaluate the Effect of JNJ-61803534 on the Pharmacokinetics of Midazolam in Healthy Participants
A Phase 1 study testing JNJ-61803534 and Midazolam in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.
Trial summary
The purpose of this study is to evaluate the safety and tolerability and pharmacokinetics of JNJ61803534 in healthy participants after administration of single ascending oral doses of JNJ-61803534 (Part 1) and multiple ascending oral doses of JNJ-61803534, administered for 14 consecutive days (Part 2) as well as the… 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-61803534 and Midazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteBelgium
- Study dates
- 17 May 2017to 5 Apr 2018
- 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
- Participant must have a body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m^2) (BMI = weight/height^2), and a body weight of not less than 50 kilogram (kg)
- Participant must be healthy on the basis of their medical history, a physical examination, vital signs, and 12-lead electrocardiogram (ECG) performed during screening
- Participant must be healthy on the basis of clinical laboratory tests performed during screening and at Day -1
- A woman must have a negative urine pregnancy test at screening and a negative highly sensitive serum pregnancy test on Day -1
Who cannot join
- Participant has a history of liver or renal insufficiency or significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, dermatologic, rheumatologic, psychiatric, or metabolic disturbances
- Participant has a history of malignancy before screening. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or a malignancy which is considered cured with minimal risk of recurrence
- Participant has an active acute or chronic infection (including chronic recurrent or invasive candidiasis) or diagnosed latent infection
- Participant has received an investigational treatment (including investigational vaccines) within 2 months or 5 half-lives (whichever is longer) or used an invasive investigational medical device within 3 months before the planned first dose of study treatment or is currently enrolled in an investigational study
- Participant had major surgery, (example, requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to participate in the study or within 4 weeks after the last dose of study treatment administration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-61803534 and an Open-Label Study to Evaluate the Effect of JNJ-61803534 on the Pharmacokinetics of Midazolam in Healthy Participants
The purpose of this study is to evaluate the safety and tolerability and pharmacokinetics of JNJ61803534 in healthy participants after administration of single ascending oral doses of JNJ-61803534 (Part 1) and multiple ascending oral doses of JNJ-61803534, administered for 14 consecutive days (Part 2) as well as the potential of JNJ-61803534 to interact with other drugs (Part 3).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-61803534Drug
Participants will receive JNJ-61803534 tablets orally.
PlaceboDrug
Participants will receive matching placebo.
MidazolamDrug
Participants will receive single oral dose of midazolam.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Single Ascending Dose (SAD) | Experimental | Participants will receive single oral doses of JNJ-61803534 or placebo in the fasted or fed state. Receives: Drug: JNJ-61803534; Drug: Placebo |
| Part 2: Multiple Ascending Dose (MAD) | Experimental | Participants will receive JNJ-61803534 or placebo over a 14-day period. Receives: Drug: JNJ-61803534; Drug: Placebo |
| Part 3: Drug-drug Interaction (DDI) | Experimental | Participants will receive single oral doses of midazolam on Day 1 and Day 16 and will receive JNJ-61803534 daily from Day 3 through Day 16 for 14 days at a dose based on the data from the SAD and MAD part. Receives: Drug: JNJ-61803534; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Adverse Events (AEs) as a Measure of Safety: Part 1
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.
Measured: Approximately up to 12 weeks
Percentage of Participants With AEs as a Measure of Safety: Part 2
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.
Measured: Approximately up to 14 weeks
Secondary outcomes (3)
Plasma Concentration of JNJ-61803534 (Parts 1, 2 and 3)
Plasma concentration assessment will be done to characterize the pharmacokinetics (PK) of of JNJ-61803534.
Measured: Pre-dose, up to Day 50 (Part 1), up to Day 60 (Part 2), and up to Day 63 (Part 3)
Plasma Concentration of Midazolam (Part 3)
Plasma concentration assessment will be done to characterize the effect of JNJ-61803534 on the PK of midazolam.
Measured: Pre-dose and up to Day 18
Inhibition of Stimulated IL-17A Production in Diluted Whole Blood (Parts 1 and 2)
The amount of IL-17A secreted during the ex-vivo stimulation will be measured during the dosing period.
Measured: Pre-dose, up to Day 22 (Part 1 - SAD) and up to Day 43 (Part 2 - MAD)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start17 May 2017
- Primary completion5 Apr 2018
- Study completion5 Apr 2018
Why it stopped: Terminated due to nonclinical findings
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 47 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
- NCT03139500
- Sponsor's protocol ID
- CR108320
- Other IDs
- 2016-004085-26, 61803534NAP1001, 2016
- Status last verified
- Jul 2018
- First submitted
- 2 May 2017
- Last updated
- 20 Jul 2018
- 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 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-61803534 and an Open-Label Study to Evaluate the Effect of JNJ-61803534 on the Pharmacokinetics of Midazolam in Healthy Participants
- ClinicalTrials.gov ID
- NCT03139500
- Acronym / sponsor ID
- CR108320
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to nonclinical findings
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 17 May 2017 (actual)
- Primary completion
- 5 Apr 2018 (actual)
- Study completion
- 5 Apr 2018 (actual)
- First posted
- 4 May 2017 (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 evaluate the safety and tolerability and pharmacokinetics of JNJ61803534 in healthy participants after administration of single ascending oral doses of JNJ-61803534 (Part 1) and multiple ascending oral doses of JNJ-61803534, administered for 14 consecutive days (Part 2) as well as the potential of JNJ-61803534 to interact with other drugs (Part 3).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1: Single Ascending Dose (SAD) | Experimental | Drug: JNJ-61803534, Drug: PlaceboParticipants will receive single oral doses of JNJ-61803534 or placebo in the fasted or fed state. |
| Part 2: Multiple Ascending Dose (MAD) | Experimental | Drug: JNJ-61803534, Drug: PlaceboParticipants will receive JNJ-61803534 or placebo over a 14-day period. |
| Part 3: Drug-drug Interaction (DDI) | Experimental | Drug: JNJ-61803534, Drug: MidazolamParticipants will receive single oral doses of midazolam on Day 1 and Day 16 and will receive JNJ-61803534 daily from Day 3 through Day 16 for 14 days at a dose based on the data from the SAD and MAD part. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participant must have a body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m^2) (BMI = weight/height^2), and a body weight of not less than 50 kilogram (kg)
- Participant must be healthy on the basis of their medical history, a physical examination, vital signs, and 12-lead electrocardiogram (ECG) performed during screening
- Participant must be healthy on the basis of clinical laboratory tests performed during screening and at Day -1
- A woman must have a negative urine pregnancy test at screening and a negative highly sensitive serum pregnancy test on Day -1
Key exclusion criteria (5 listed)
- Participant has a history of liver or renal insufficiency or significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, dermatologic, rheumatologic, psychiatric, or metabolic disturbances
- Participant has a history of malignancy before screening. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or a malignancy which is considered cured with minimal risk of recurrence
- Participant has an active acute or chronic infection (including chronic recurrent or invasive candidiasis) or diagnosed latent infection
- Participant has received an investigational treatment (including investigational vaccines) within 2 months or 5 half-lives (whichever is longer) or used an invasive investigational medical device within 3 months before the planned first dose of study treatment or is currently enrolled in an investigational study
- Participant had major surgery, (example, requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to participate in the study or within 4 weeks after the last dose of study treatment administration
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-61803534Participants will receive JNJ-61803534 tablets orally. | Drug | Part 1: Single Ascending Dose (SAD), Part 2: Multiple Ascending Dose (MAD), Part 3: Drug-drug Interaction (DDI) |
| PlaceboParticipants will receive matching placebo. | Drug | Part 1: Single Ascending Dose (SAD), Part 2: Multiple Ascending Dose (MAD) |
| MidazolamParticipants will receive single oral dose of midazolam. | Drug | Part 3: Drug-drug Interaction (DDI) |
Primary outcome
Percentage of Participants With Adverse Events (AEs) as a Measure of Safety: Part 1
Time frame: Approximately up to 12 weeks
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.
Percentage of Participants With AEs as a Measure of Safety: Part 2
Time frame: Approximately up to 14 weeks
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.
3 secondary outcomes
Plasma Concentration of JNJ-61803534 (Parts 1, 2 and 3)
Time frame: Pre-dose, up to Day 50 (Part 1), up to Day 60 (Part 2), and up to Day 63 (Part 3)
Plasma Concentration of Midazolam (Part 3)
Time frame: Pre-dose and up to Day 18
Inhibition of Stimulated IL-17A Production in Diluted Whole Blood (Parts 1 and 2)
Time frame: Pre-dose, up to Day 22 (Part 1 - SAD) and up to Day 43 (Part 2 - MAD)
Results and safety
The study was stopped early (reason given: Terminated due to nonclinical findings). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2018.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-61803534 and Midazolam in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.
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 4 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: stopped early, as of the sponsor's last update on 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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 was stopped early (reason given: Terminated due to nonclinical findings). Results are not available in the source record.
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?
Percentage of Participants With Adverse Events (AEs) as a Measure of Safety: Part 1 (time frame: Approximately up to 12 weeks). The study lists 2 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 20 Jul 2018.