HealthyPhase 1NCT04206488
A Study of JNJ-70033093 and Digoxin in Healthy Participants
A Phase 1 study testing JNJ-70033093 and Digoxin 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 potential pharmacokinetic (PK) interaction between JNJ-70033093 and digoxin in healthy participants after single dose administration and at steady state. 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 and Digoxin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 9 Jan 2020to 9 Jun 2021
- 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, Electrocardiogram (ECG), and laboratory test results, including serum chemistry, blood coagulation, hematology, and urinalysis performed at screening. 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. This determination must be recorded in the participant's source documents and initialed by the investigator
- Normal renal function at screening as evidenced by an estimated glomerular filtration rate (eGFR) of greater than or equal to (>=) 90 milliliter per minute (mL/min) per 1.73 meter square (m^2) calculated with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
- A woman of childbearing potential must have a negative serum beta human chorionic gonadotropin (beta-hCG) test at screening and a negative urine (beta-hCG) test on Day -1 of Period 1
- Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies. Before screening, a woman must either be: a) Not of childbearing potential b) Of childbearing potential c) Women must have no history of excessive menstrual bleeding or hemorrhage following pregnancy delivery
- Body mass index (BMI; weight [kilogram {kg}] per height square (height^2 [meter^2]) between 18.0 and 30.0 kilogram per meter square (kg/m^2) (inclusive), and body weight not less than 55 kg
- A 12-lead ECG consistent with normal cardiac conduction and function at screening and on Day 1 of Period 1, including: a) Sinus rhythm, b) Heart rate between 55 and 90 beats per minute (bpm), c) Corrected QT (QTc) interval of less than or equal to (<=) 450 milliseconds (ms) for male participants and <= 470 ms for female participants (QT interval will be corrected for heart rate using the Fridericia correction, d) QRS interval of less than (<) 110 ms, e) PR interval <200 ms, f) Morphology consistent with healthy cardiac conduction and function
Who cannot join
- Participant is a woman who is pregnant, breastfeeding, or planning to become pregnant during this study or within 34 days after the last study drug administration
- History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, gastrointestinal disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- History of clinically significant ECG abnormalities, sinus node disease, or incomplete atrioventricular (AV) block or a family history of prolonged QT interval syndrome
- Positive blood screen for hepatitis C virus antibody, hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) type 1 and type 2 antibody
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for oral contraceptives, hormonal replacement therapy (HRT), and paracetamol, within 14 days before the first dose of the study drug is scheduled
- Received an experimental drug/placebo or used an experimental medical device within 3 months or within a period less than 5 times the drug's half-life (whichever is longer) prior to the planned first dose of study drugs or is enrolled in an investigational study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Open-label, Fixed-sequence, Study Evaluating the Two-way Drug-drug Interaction Between JNJ-70033093 and Digoxin in Healthy Subjects
The purpose of this study is to evaluate the potential pharmacokinetic (PK) interaction between JNJ-70033093 and digoxin in healthy participants after single dose administration and at steady state.
- Conditions
- Healthy
- Being tested
- JNJ-70033093, Digoxin
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
Participants will receive JNJ-70033093 orally.
DigoxinDrug
Also called Lanoxin
Participants will receive digoxin orally.
| Study group | Role | What they receive |
|---|---|---|
| JNJ-70033093 + Digoxin | Experimental | Participants will receive JNJ-70033093 as oral capsules (Treatment A) in Period 1, followed by digoxin tablets as loading dose and maintenance doses (Treatment B) in Period 2, and then digoxin tablets along with JNJ-70033093 (Treatment C) in Period 3. There will be a washout period of minimum 5 days (and maximum 7 days) between the last dosing day of Period 1 and the first dosing day of Period 2. There is no washout between Periods 2 and 3 (that is, the last day of Treatment B is to be followed by the first day of Treatment C). Receives: Drug: JNJ-70033093; Drug: Digoxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) Geometric Mean Ratio of Treatment C (JNJ-70033093 + Digoxin) Relative to Treatment A (JNJ-70033093)
Cmax is the maximum observed plasma concentration. Cmax geometric mean ratio of Treatment C (JNJ-70033093 + digoxin) relative to Treatment A (JNJ-70033093) will be reported to assess the effect of digoxin on the pharmacokinetics (PK) of JNJ-70033093.
Measured: Up to Day 21
Cmax Geometric Mean Ratio of Treatment C (JNJ-70033093 + Digoxin) Relative to Treatment B (Digoxin)
Cmax is the maximum observed plasma concentration. Cmax geometric mean ratio of Treatment C (JNJ-70033093 + Digoxin) relative to Treatment B (digoxin) will be reported to assess the effect of JNJ-70033093 on the PK of digoxin.
Measured: Up to Day 21
Area Under the Plasma Concentration-time Curve from Time 0 to 24 Hours Postdose (AUC [0-24 hours]) Geometric Mean Ratio of Treatment C (JNJ-70033093 + Digoxin) Relative to Treatment A (JNJ-70033093)
AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours postdose. AUC (0-24) geometric mean ratio of Treatment C (JNJ-70033093 + digoxin) relative to Treatment A (JNJ-70033093) will be reported to assess the effect of digoxin on the PK of JNJ-70033093.
Measured: Up to 24 hours postdose
AUC (0-24) Geometric Mean Ratio of Treatment C (JNJ-70033093 + Digoxin) Relative to Treatment B (Digoxin)
AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours postdose. AUC (0-24) geometric mean ratio of Treatment C (JNJ-70033093 + digoxin) relative to Treatment B (digoxin) will be reported to assess the effect of JNJ-70033093 on the PK of digoxin.
Measured: Up to 24 hours postdose
Secondary outcomes (5)
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 medicinal (investigational or non-investigational) product does not necessarily have a causal relationship with the treatment. Therefore, it can be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product.
Measured: Up to 63 Days
Number of Participants with Vital Sign Abnormalities as a Measure of Safety and Tolerability
Number of participants with vital sign (tympanic temperature, resting [supine] pulse rate, and blood pressure) abnormalities will be reported.
Measured: Up to 63 Days
Number of Participants with 12-lead Electrocardiogram (ECG) Abnormalities as a Measure of Safety and Tolerability
Number of participants with 12-lead ECG abnormalities will be reported.
Measured: Up to 63 Days
Number of Participants with Laboratory Abnormalities as a Measure of Safety and Tolerability
Number of participants with laboratory abnormalities (hematology, coagulation tests, clinical chemistry, and urinalysis) will be reported.
Measured: Up to 63 Days
Percent Change From Baseline in Activated Partial Thromboplastin Time (aPTT)
Percent change from baseline in aPTT will be reported.
Measured: Baseline up to Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start9 Jan 2020
- Primary completion9 Jun 2021
- Study completion9 Jun 2021
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04206488
- Sponsor's protocol ID
- CR108712
- Other IDs
- 70033093THR1001, 2019-003783-46, 2019
- Status last verified
- Mar 2025
- First submitted
- 18 Dec 2019
- 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label, Fixed-sequence, Study Evaluating the Two-way Drug-drug Interaction Between JNJ-70033093 and Digoxin in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04206488
- Acronym / sponsor ID
- CR108712
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 9 Jun 2021 (actual)
- Study completion
- 9 Jun 2021 (actual)
- First posted
- 20 Dec 2019 (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 potential pharmacokinetic (PK) interaction between JNJ-70033093 and digoxin in healthy participants after single dose administration and at steady state.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JNJ-70033093 + Digoxin | Experimental | Drug: JNJ-70033093, Drug: DigoxinParticipants will receive JNJ-70033093 as oral capsules (Treatment A) in Period 1, followed by digoxin tablets as loading dose and maintenance doses (Treatment B) in Period 2, and then digoxin tablets along with JNJ-70033093 (Treatment C) in Period 3. There will be a washout period of minimum 5 days (and maximum 7 days) between the last dosing day of Period 1 and the first dosing day of Period 2. There is no washout between Periods 2 and 3 (that is, the last day of Treatment B is to be followed by the first day of Treatment C). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy on the basis of physical examination, medical history, vital signs, Electrocardiogram (ECG), and laboratory test results, including serum chemistry, blood coagulation, hematology, and urinalysis performed at screening. 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. This determination must be recorded in the participant's source documents and initialed by the investigator
- Normal renal function at screening as evidenced by an estimated glomerular filtration rate (eGFR) of greater than or equal to (>=) 90 milliliter per minute (mL/min) per 1.73 meter square (m^2) calculated with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
- A woman of childbearing potential must have a negative serum beta human chorionic gonadotropin (beta-hCG) test at screening and a negative urine (beta-hCG) test on Day -1 of Period 1
- Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies. Before screening, a woman must either be: a) Not of childbearing potential b) Of childbearing potential c) Women must have no history of excessive menstrual bleeding or hemorrhage following pregnancy delivery
- Body mass index (BMI; weight [kilogram {kg}] per height square (height^2 [meter^2]) between 18.0 and 30.0 kilogram per meter square (kg/m^2) (inclusive), and body weight not less than 55 kg
Key exclusion criteria (6 listed)
- Participant is a woman who is pregnant, breastfeeding, or planning to become pregnant during this study or within 34 days after the last study drug administration
- History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, gastrointestinal disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- History of clinically significant ECG abnormalities, sinus node disease, or incomplete atrioventricular (AV) block or a family history of prolonged QT interval syndrome
- Positive blood screen for hepatitis C virus antibody, hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) type 1 and type 2 antibody
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for oral contraceptives, hormonal replacement therapy (HRT), and paracetamol, within 14 days before the first dose of the study drug is scheduled
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-70033093Also: BMS-986177Participants will receive JNJ-70033093 orally. | Drug | JNJ-70033093 + Digoxin |
| DigoxinAlso: LanoxinParticipants will receive digoxin orally. | Drug | JNJ-70033093 + Digoxin |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) Geometric Mean Ratio of Treatment C (JNJ-70033093 + Digoxin) Relative to Treatment A (JNJ-70033093)
Time frame: Up to Day 21
Cmax is the maximum observed plasma concentration. Cmax geometric mean ratio of Treatment C (JNJ-70033093 + digoxin) relative to Treatment A (JNJ-70033093) will be reported to assess the effect of digoxin on the pharmacokinetics (PK) of JNJ-70033093.
Cmax Geometric Mean Ratio of Treatment C (JNJ-70033093 + Digoxin) Relative to Treatment B (Digoxin)
Time frame: Up to Day 21
Cmax is the maximum observed plasma concentration. Cmax geometric mean ratio of Treatment C (JNJ-70033093 + Digoxin) relative to Treatment B (digoxin) will be reported to assess the effect of JNJ-70033093 on the PK of digoxin.
Area Under the Plasma Concentration-time Curve from Time 0 to 24 Hours Postdose (AUC [0-24 hours]) Geometric Mean Ratio of Treatment C (JNJ-70033093 + Digoxin) Relative to Treatment A (JNJ-70033093)
Time frame: Up to 24 hours postdose
AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours postdose. AUC (0-24) geometric mean ratio of Treatment C (JNJ-70033093 + digoxin) relative to Treatment A (JNJ-70033093) will be reported to assess the effect of digoxin on the PK of JNJ-70033093.
AUC (0-24) Geometric Mean Ratio of Treatment C (JNJ-70033093 + Digoxin) Relative to Treatment B (Digoxin)
Time frame: Up to 24 hours postdose
AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours postdose. AUC (0-24) geometric mean ratio of Treatment C (JNJ-70033093 + digoxin) relative to Treatment B (digoxin) will be reported to assess the effect of JNJ-70033093 on the PK of digoxin.
5 secondary outcomes
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Time frame: Up to 63 Days
Number of Participants with Vital Sign Abnormalities as a Measure of Safety and Tolerability
Time frame: Up to 63 Days
Number of Participants with 12-lead Electrocardiogram (ECG) Abnormalities as a Measure of Safety and Tolerability
Time frame: Up to 63 Days
Number of Participants with Laboratory Abnormalities as a Measure of Safety and Tolerability
Time frame: Up to 63 Days
Percent Change From Baseline in Activated Partial Thromboplastin Time (aPTT)
Time frame: Baseline up to Day 21
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 30 Mar 2025.
- Individual participant dataSharing planned: 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
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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
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-70033093 and Digoxin 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 6 inclusion and 6 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?
Maximum Observed Plasma Concentration (Cmax) Geometric Mean Ratio of Treatment C (JNJ-70033093 + Digoxin) Relative to Treatment A (JNJ-70033093) (time frame: Up to Day 21). 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 30 Mar 2025.