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HealthyPhase 1NCT04448964

A Study of JNJ-70033093 in Healthy Participants

A Phase 1 study testing JNJ-70033093 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the pharmacokinetics (PK) and relative bioavailability of a single dose of JNJ-70033093 spray dried dispersion (SDD) tablets compared with JNJ-70033093 SDD granule capsules in healthy participants under fasting conditions in Part 1 and 2 and to assess the effect of food on the… Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
JNJ-70033093
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteBelgium
Study dates
26 Jun 2020to 14 Nov 2020
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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and on Day -1 of Treatment Period 1. If there are abnormalities, the investigator may decide that the abnormalities or deviations from normal are not clinically significant, in which case the participant may be included
  • Healthy on the basis of safety laboratory tests performed at screening and on Day -1 of Period 1. If the results of the safety laboratory tests 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
  • If a woman, must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening and urine pregnancy test on Day 1 of each treatment period
  • Body mass index (BMI) between 18.0 and 30.0 kilogram per meter square (kg/m^2, inclusive (BMI = weight/height^2), and body weight not less than 50 kg at screening
  • After being supine for 5 minutes, systolic blood pressure between 90 and 140 millimeter of Mercury (mmHg), inclusive; and no higher than 90 mmHg diastolic blood pressure at screening and on Day -1 of Treatment Period 1
  • Must sign an ICF indicating that they understand the purpose of, and procedures required for the study and is willing to participate in the study
  • Before randomization, a woman must be either: a.) Not of childbearing potential (Postmenopausal- no menses for 12 months without an alternative medical cause and Permanently sterile- include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy); b.) of childbearing potential and practicing a highly effective method of contraception for at least 3 months prior to the study entry and agrees to remain on a highly effective method of contraception throughout the study and for at least 34 days after the last dose of study drug
  • During the study, a man who is sexually active with a woman of childbearing potential or with a woman who is pregnant must agree to use a barrier method of contraception

Who cannot join

  • History of any known illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant or that could prevent, limit or confound the protocol specified assessments.
  • History of any clinically significant drug or food allergies (such as anaphylaxis or hepatotoxicity) and known allergy to the study drugs or any of the excipients of the formulation
  • History of allergy to or unwillingness to consume any component of the standardized high-fat breakfast menu to be provided in this study
  • Use of any systemic strong cytochrome P450 P glycoprotein ([CYP] 3A4/P-gp) inducers (example, [rifampin]) or inhibitors (example, [itraconazole]) within 4 weeks before the first dose of the study drug
  • Participants with current hepatitis B infection (confirmed by hepatitis B surface antigen [HBsAg]), or hepatitis C infection (confirmed by hepatitis C virus [HCV] antibody), or human immunodeficiency virus type 1 (HIV-1) or human immunodeficiency virus type 2 (HIV-2) infection at study screening
  • Clinically significant abnormal values for hematology, coagulation, clinical chemistry or urinalysis at screening or on Day -1 of Treatment Period 1 as determined by the investigator or appropriate designee
  • Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for hormonal contraceptives, hormone replacement therapy and paracetamol (acetaminophen) within 14 days before the first dose of the study drug until completion of the study
  • Any of the following on a 12-lead electrocardiogram (ECG) and the assessment of QT interval, confirmed by repeat at screening and Day -1 of Treatment Period 1: a.) Heart rate greater than (>) 100 beats per minute (bpm); b.) PR > 210 milliseconds (ms); c.) QRS > 120 ms; d.) QT corrected according to Fridericia's formula (QTcF) > 450 ms for male and > 470 ms for female

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Clinical Pharmacology Unit

    Merksem, 2170

Other trials in Belgium

About this study

Official title: A Randomized, Open-Label, 3-way Cross-over (Part 1) and 2-way Cross-over (Part 2) Study in Healthy Participants to Evaluate the Relative Bioavailability and the Food Effect of an Oral Tablet Formulation Relative to a Capsule Formulation of JNJ-70033093

The purpose of this study is to evaluate the pharmacokinetics (PK) and relative bioavailability of a single dose of JNJ-70033093 spray dried dispersion (SDD) tablets compared with JNJ-70033093 SDD granule capsules in healthy participants under fasting conditions in Part 1 and 2 and to assess the effect of food on the bioavailability of a single dose of JNJ-70033093 SDD tablets in Part 1.

Conditions
Healthy
Being tested
JNJ-70033093

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-70033093Drug

    Also called BMS-986177

    JNJ-70033093 will be administered orally as per assigned treatment sequence.

Study groups in NCT04448964
Study groupRoleWhat they receive
Part 1: Treatment Sequence ABCExperimentalParticipants will receive a single dose of JNJ-70033093 spray-dried dispersion (SDD) tablet under fasted conditions (Treatment A) in Treatment Period 1, followed by JNJ-70033093 SDD tablet in fed conditions (Treatment B) in Treatment Period 2, and then JNJ-70033093 SDD granule capsule under fasted conditions (Treatment C) in Treatment Period 3 on Day 1 of each Period during Part 1. There will be a wash-out period of at least 5 days and up to 2 weeks between Day 1 of each treatment period.
Receives: Drug: JNJ-70033093
Part 1: Treatment Sequence BCAExperimentalParticipants will receive Treatment B in Treatment Period 1, followed by Treatment C in Treatment Period 2, and then Treatment A in Treatment Period 3 on Day 1 of each Period during Part 1. There will be a wash-out period of at least 5 days and up to 2 weeks between Day 1 of each treatment period.
Receives: Drug: JNJ-70033093
Part 1: Treatment Sequence CABExperimentalParticipants will receive Treatment C in Treatment Period 1, followed by Treatment A in Treatment Period 2, and then Treatment B in Treatment Period 3 on Day 1 of each Period during Part 1. There will be a wash-out period of at least 5 days and up to 2 weeks between Day 1 of each treatment period.
Receives: Drug: JNJ-70033093
Part 1: Treatment Sequence ACBExperimentalParticipants will receive Treatment A in Treatment Period 1, followed by Treatment C in Treatment Period 2, and then Treatment B in Treatment Period 3 on Day 1 of each Period during Part 1. There will be a wash-out period of at least 5 days and up to 2 weeks between Day 1 of each treatment period.
Receives: Drug: JNJ-70033093
Part 1: Treatment Sequence BACExperimentalParticipants will receive Treatment B in Treatment Period 1, followed by Treatment A in Treatment Period 2, and then Treatment C in Treatment Period 3 on Day 1 of each Period during Part 1. There will be a wash-out period of at least 5 days and up to 2 weeks between Day 1 of each treatment period.
Receives: Drug: JNJ-70033093
Part 1: Treatment Sequence CBAExperimentalParticipants will receive Treatment C in Treatment Period 1, followed by Treatment B in Treatment Period 2, and then Treatment A in Treatment Period 3 on Day 1 of each Period during Part 1. There will be a wash-out period of at least 5 days and up to 2 weeks between Day 1 of each treatment period.
Receives: Drug: JNJ-70033093
Part 2: Treatment Sequence DEExperimentalParticipants will receive Treatment D (single dose of JNJ-70033093 SDD tablet in fed conditions) in Treatment Period 1, and then Treatment E (single dose of JNJ-70033093 SDD granule capsule under fasted conditions) in Treatment Period 2 on Day 1 of each Period during Part 2. There will be a wash-out period of at least 5 days and up to 2 weeks between Day 1 of each treatment period.
Receives: Drug: JNJ-70033093
Part 2: Treatment Sequence EDExperimentalParticipants will receive Treatment E in Treatment Period 1, and then Treatment D in Treatment Period 2 on Day 1 of each Period during Part 2. There will be a wash-out period of at least 5 days and up to 2 weeks between Day 1 of each treatment period.
Receives: Drug: JNJ-70033093

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1 and 2: Maximum Observed Plasma Concentration (Cmax) of JNJ-70033093

    Cmax is defined as maximum observed plasma concentration after administration of JNJ-70033093.

    Measured: Up to 72 hours post dose

  2. Part 1 and 2: Area Under the Plasma Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC [0-last]) of JNJ-70033093

    AUC (0-last) is defined as area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration after administration of JNJ-70033093.

    Measured: Up to 72 hours post dose

  3. Part 1 and 2: Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUC [0-inf]) of JNJ-70033093

    AUC (0-inf) is defined as area under the plasma concentration-time curve from time 0 to infinity after administration of JNJ-70033093.

    Measured: Up to 72 hours post dose

  4. Part 1 and 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-70033093

    Tmax is defined time to reach the maximum observed plasma concentration.

    Measured: Up to 72 hours post dose

  5. Part 1 and 2: Apparent Elimination Half-life (t1/2) of JNJ-70033093

    Apparent elimination half-life associated with the terminal slope lambda(z) of the semilogarithmic drug concentration-time curve.

    Measured: Up to 72 hours post dose

Secondary outcomes (4)

  1. Part 1 and 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability

    An AE is any untoward medical occurrence in a clinical study participant administered a investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment.

    Measured: Up to 2 Months

  2. Part 1 and 2: Number of Participants with Clinically Significant Changes in Vital Signs

    Number of participants with clinically significant changes in vital signs including temperature (axillary), pulse rate, respiratory rate, blood pressure will be reported.

    Measured: Up to 2 Months

  3. Part 1 and 2: Number of Participants with Abnormalities in Electrocardiogram (ECG)

    Number of participants with abnormalities in ECG will be reported.

    Measured: Up to 2 Months

  4. Part 1 and 2: Number of Participants with Clinically Significant Changes in Physical Examination

    Number of participants with clinically significant changes in physical examination including height and body weight will be reported.

    Measured: Up to 2 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2020
  2. Study start26 Jun 2020
  3. Primary completion14 Nov 2020
  4. Study completion14 Nov 2020

Resources

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
Crossover
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04448964
Sponsor's protocol ID
CR108803
Other IDs
2020-000565-17, 70033093THR1005
Status last verified
Mar 2025
First submitted
25 Jun 2020
Last updated
30 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JNJ-70033093 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 8 inclusion and 8 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 30 Mar 2025. 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 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 and 2: Maximum Observed Plasma Concentration (Cmax) of JNJ-70033093 (time frame: Up to 72 hours post dose). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04448964.

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 30 Mar 2025.

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