Hepatic ImpairmentPhase 1NCT02524717
A Study to Evaluate the Pharmacokinetics of JNJ-56021927 in Participants With Mild or Moderate Hepatic Impairment Compared With Participants With Normal Hepatic Function
A Phase 1 study testing JNJ-56021927 in people with Hepatic Impairment, run by Aragon Pharmaceuticals, Inc. at 2 sites in United States.
Trial summary
The purpose of this study is to characterize the pharmacokinetics of JNJ-56021927 in participants with mild and moderate hepatic impairment. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- JNJ-56021927
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Aug 2015to 9 Feb 2017
- 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 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must have a clinically stable hepatic function as confirmed by the serum bilirubin and transaminase levels measured during Screening and those measured within 24 hours prior to study drug administration
- Sign an informed consent document indicating that the participant understands the purpose of and procedures required for the study and are willing to participate in the study. Participants must not have hepatic encephalopathy greater than or equal to (>=) Grade 3 where the participant lacks the capacity to provide informed consent as judged by the investigator. Mild or moderate hepatic encephalopathy that would not impede informed consent in the investigator's judgment is permitted
- Willing and able to adhere to the prohibitions and restrictions as specified in the protocol
- If a man is sexually active with a woman of childbearing potential and has not had a vasectomy, he must agree to use an adequate contraception method as deemed appropriate by the Investigator, always use a condom during sexual intercourse, and agree to not donate sperm during the study and for 3 months after receiving the study drug
- Body mass index (BMI) between 18 and 35 kilogram (kg)/meter (m)^2 (inclusive), and body weight not less than 50 kg
- The participant must have a total Child-Pugh score of 5 to 6, inclusive (mild); or 7 to 9, inclusive (moderate); the investigator will determine hepatic impairment
Who cannot join
- Screening thyroid-stimulating hormone (TSH) level greater than (>) Upper Limit of Normal (ULN), or participants with known history of thyroid disorders
- Participant who is on thyroid replacement therapy
- History of drug abuse according to Diagnostic and Statistical Manual of Mental Disorders (4th edition) (DSM-IV) criteria within 2 years before Screening or positive test result(s) for drugs of abuse (that is, opiates, barbiturates, benzodiazepines, cocaine, cannabinoids, and amphetamines) at Screening or Day -1. A positive test for participants with prescriptions for drugs that may interfere with the drug screen (that is, opiates and benzodiazepines) may be allowed
- Known allergy to the study drug or any of the excipients of the formulation
- Intention to donate blood or blood products during the study or for 3 months after the administration of the study drug
- A man who plans to father a child while enrolled in the study or for 3 months after receiving the study drug
Show all 13Show fewer
- Known history of seizure or condition that may predispose to seizure or on medication that lowers seizure threshold
- History of stomach or intestinal surgery or resection that would potentially alter absorption or excretion of orally administered drugs
- Gall bladder (example, cholecystitis and cholelithiasis) or biliary tract disease
- Clinically significant renal laboratory findings including serum creatinine level greater than (>) 1.5 times ULN
- Inability to fast for 12 hours
- History of or current clinically significant medical illness
- Positive test for human immunodeficiency virus (HIV) 1 and 2 antibodies
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Knoxville, Tennessee
Study site
San Antonio, Texas
About this study
Official title: A Single-Dose, Open-Label Study to Evaluate the Pharmacokinetics of JNJ-56021927 in Subjects With Mild or Moderate Hepatic Impairment Compared With Subjects With Normal Hepatic Function
The purpose of this study is to characterize the pharmacokinetics of JNJ-56021927 in participants with mild and moderate hepatic impairment.
Read the detailed description
This is an open-label (all people know the identity of the intervention), single-dose, single-center, non-randomized study of JNJ-56021927 in participants who either have hepatic impairment or qualify for the control group. The study consists of 3 Phases: Screening Phase (21 Days), open-label treatment Phase (8 Days) and follow up Phase (49 Days). The duration of participation in the study for each participant is approximately 78 Days. Primarily the pharmacokinetics of JNJ-56021927 will be measured. Participants' safety will be monitored throughout the study.
- Conditions
- Hepatic Impairment
- Being tested
- JNJ-56021927
- Keywords
- Hepatic Impairment, JNJ-56021927
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-56021927Drug
Participants will receive JNJ-56021927 240 milligram (mg) orally once on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| JNJ-56021927 | Experimental | Participants with mild and moderate hepatic impairment and with normal hepatic function will receive JNJ-56021927 240 milligram (mg) orally once on Day 1. Receives: Drug: JNJ-56021927 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) of JNJ-56021927
The Cmax is the maximum observed plasma concentration of JNJ-56021927.
Measured: Pre-dose up to 1344 hours post-dose
Maximum Plasma Concentration Corrected for Unbound Fraction (Cmax_unb) of JNJ-56021927
The Cmax_unb is the maximum observed plasma concentration corrected for unbound fraction of JNJ-56021927.
Measured: Pre-dose up to 1344 hours post-dose
Time to Reach the Maximum Plasma Concentration (Tmax) of JNJ-56021927
The Tmax is the time to reach the maximum observed plasma concentration of JNJ-56021927.
Measured: Pre-dose up to 1344 hours post-dose
Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC[0-24]) Post Dose of JNJ-56021927
The AUC(0-24hrs) is the area under the plasma concentration-time curve from 0 to 24 hours post dosing.
Measured: Pre-dose up to 1344 hours post-dose
Area Under the Plasma Concentration-Time Curve From 0 to 168 Hours (AUC[0-168]) Post Dose of JNJ-56021927
The AUC(0-168hrs) is the area under the plasma concentration-time curve from 0 to 168 hours post dosing.
Measured: Pre-dose up to 1344 hours post-dose
Area Under the Plasma Concentration-Time Curve From 0 to Last Quantifiable Concentration (AUC[0-last]) Post Dose of JNJ-56021927
The AUC(0-last) is the area under the plasma concentration-time curve from 0 to time of the last quantifiable concentration.
Measured: Pre-dose up to 1344 hours post-dose
Area Under the Plasma Concentration-Time Curve From 0 to Last Quantifiable Concentration Corrected for Unbound Fraction (AUC[last_unb]) Post Dose of JNJ-56021927
The AUC(last_unb) corrected for unbound fraction is the area under the plasma concentration-time curve from 0 to time of the last quantifiable concentration.
Measured: Pre-dose up to 1344 hours post-dose
Area Under the Plasma Concentration-Time Curve From 0 to Infinite Time (AUC[0-infinity]) Post Dose of JNJ-56021927
The AUC (0-infinity) is the area under the plasma JNJ-56021927 concentration-time curve from time 0 to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z), in which AUC(0-last) is area under the plasma JNJ-56021927 concentration-time curve from time zero to time of the last quantifiable concentration, C(last) is the last observed quantifiable concentration and lambda(z) is elimination rate constant.
Measured: Pre-dose up to 1344 hours post-dose
Area Under the Plasma Concentration-Time Curve From 0 to Infinite Time Corrected for Unbound Fraction (AUC[infinity_unb]) Post Dose of JNJ-56021927
The AUC(infinity_unb) is the area under the plasma JNJ-56021927 concentration-time curve from time 0 to infinite time corrected for unbound fraction, calculated as the sum of AUC (0-last) and C(last)/lambda(z), in which AUC(0-last) is area under the plasma JNJ-56021927 concentration-time curve from time zero to time of the last quantifiable concentration, C(last) is the last observed quantifiable concentration and lambda(z) is elimination rate constant.
Measured: Pre-dose up to 1344 hours post-dose
Percentage of Area Under the Plasma Concentration-Time Curve Obtained by Extrapolation (%AUC[infinity,ex])
The %AUC[infinity,ex] is calculated by dividing the difference of AUC(0-infinity) and AUC(0-last) by AUC(0-infinity) and then multiplying by 100, (AUC[0-infinity] - AUC[0-last])*100/AUC[0-infinity].
Measured: Pre-dose up to 1344 hours post-dose
Terminal Half-life (t[1/2]) of JNJ-56021927
Elimination half-life associated with the terminal slope Lambda (z) of the semi logarithmic drug concentration-time curve, calculated as 0.693/Lambda (z).
Measured: Pre-dose up to 1344 hours post-dose
Elimination Rate Constant (Lambda [z]) of JNJ-56021927
The Lambda (z) determined by first-order rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
Measured: Pre-dose up to 1344 hours post-dose
Time of Last Measurable Plasma Concentration (Tlast) of JNJ-56021927
Time to last measurable plasma concentration is evaluated.
Measured: Pre-dose up to 1344 hours post-dose
Total Apparent Clearance (CL/F) of JNJ-56021927
The CL/F is defined as Dose/AUC (0-infinity).
Measured: Pre-dose up to 1344 hours post-dose
Apparent Volume of Distribution (Vd/F) of JNJ-56021927
The Vd/F is defined as Dose/[Lambda (z)*AUC (0-infinity)].
Measured: Pre-dose up to 1344 hours post-dose
Metabolite to Parent Drug Ratio for Maximum Observed Plasma Concentration (MPR Cmax)
The (MPR Cmax) is metabolite to parent drug ratio for maximum observed plasma concentration.
Measured: Pre-dose up to 1344 hours post-dose
Metabolite to Parent Drug Ratio for Area Under the Plasma Concentration-Time Curve From Time 0 to Last Observed Quantifiable Concentration (MPR AUC[0-last])
The MPR AUClast is metabolite to parent drug ratio for area under the plasma concentration-time curve from time 0 to last quantifiable concentration (AUC [0-last]).
Measured: Pre-dose up to 1344 hours post-dose
Metabolite to Parent Drug Ratio for Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (MPR AUC [0-infinity])
The MPR AUC [0-infinity] is metabolite to parent drug ratio for area under the plasma concentration-time curve from time zero to extrapolated infinite time (AUC [0-infinity]).
Measured: Pre-dose up to 1344 hours post-dose
Secondary outcomes (1)
Number of Participants with Adverse Events (AEs) and Serious AEs
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (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: Screening up to follow-up (56 days after dose administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study start13 Aug 2015
- Primary completion9 Feb 2017
- Study completion9 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aragon Pharmaceuticals, Inc.
- 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
- NCT02524717
- Sponsor's protocol ID
- CR107774
- Other IDs
- 56021927PCR1018
- Status last verified
- Jan 2025
- First submitted
- 13 Aug 2015
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Open-Label Study to Evaluate the Pharmacokinetics of JNJ-56021927 in Subjects With Mild or Moderate Hepatic Impairment Compared With Subjects With Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT02524717
- Acronym / sponsor ID
- CR107774
- Conditions
- Hepatic Impairment
- Keywords
- Hepatic Impairment, JNJ-56021927
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Aragon Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Aug 2015 (actual)
- Primary completion
- 9 Feb 2017 (actual)
- Study completion
- 9 Feb 2017 (actual)
- First posted
- 17 Aug 2015 (estimated)
- 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 characterize the pharmacokinetics of JNJ-56021927 in participants with mild and moderate hepatic impairment.
Detailed description
This is an open-label (all people know the identity of the intervention), single-dose, single-center, non-randomized study of JNJ-56021927 in participants who either have hepatic impairment or qualify for the control group. The study consists of 3 Phases: Screening Phase (21 Days), open-label treatment Phase (8 Days) and follow up Phase (49 Days). The duration of participation in the study for each participant is approximately 78 Days. Primarily the pharmacokinetics of JNJ-56021927 will be measured. Participants' safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JNJ-56021927 | Experimental | Drug: JNJ-56021927Participants with mild and moderate hepatic impairment and with normal hepatic function will receive JNJ-56021927 240 milligram (mg) orally once on Day 1. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must have a clinically stable hepatic function as confirmed by the serum bilirubin and transaminase levels measured during Screening and those measured within 24 hours prior to study drug administration
- Sign an informed consent document indicating that the participant understands the purpose of and procedures required for the study and are willing to participate in the study. Participants must not have hepatic encephalopathy greater than or equal to (>=) Grade 3 where the participant lacks the capacity to provide informed consent as judged by the investigator. Mild or moderate hepatic encephalopathy that would not impede informed consent in the investigator's judgment is permitted
- Willing and able to adhere to the prohibitions and restrictions as specified in the protocol
- If a man is sexually active with a woman of childbearing potential and has not had a vasectomy, he must agree to use an adequate contraception method as deemed appropriate by the Investigator, always use a condom during sexual intercourse, and agree to not donate sperm during the study and for 3 months after receiving the study drug
- Body mass index (BMI) between 18 and 35 kilogram (kg)/meter (m)^2 (inclusive), and body weight not less than 50 kg
Key exclusion criteria (13 listed)
- Screening thyroid-stimulating hormone (TSH) level greater than (>) Upper Limit of Normal (ULN), or participants with known history of thyroid disorders
- Participant who is on thyroid replacement therapy
- History of drug abuse according to Diagnostic and Statistical Manual of Mental Disorders (4th edition) (DSM-IV) criteria within 2 years before Screening or positive test result(s) for drugs of abuse (that is, opiates, barbiturates, benzodiazepines, cocaine, cannabinoids, and amphetamines) at Screening or Day -1. A positive test for participants with prescriptions for drugs that may interfere with the drug screen (that is, opiates and benzodiazepines) may be allowed
- Known allergy to the study drug or any of the excipients of the formulation
- Intention to donate blood or blood products during the study or for 3 months after the administration of the study drug
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-56021927Participants will receive JNJ-56021927 240 milligram (mg) orally once on Day 1. | Drug | JNJ-56021927 |
Primary outcome
Maximum Plasma Concentration (Cmax) of JNJ-56021927
Time frame: Pre-dose up to 1344 hours post-dose
The Cmax is the maximum observed plasma concentration of JNJ-56021927.
Maximum Plasma Concentration Corrected for Unbound Fraction (Cmax_unb) of JNJ-56021927
Time frame: Pre-dose up to 1344 hours post-dose
The Cmax_unb is the maximum observed plasma concentration corrected for unbound fraction of JNJ-56021927.
Time to Reach the Maximum Plasma Concentration (Tmax) of JNJ-56021927
Time frame: Pre-dose up to 1344 hours post-dose
The Tmax is the time to reach the maximum observed plasma concentration of JNJ-56021927.
Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC[0-24]) Post Dose of JNJ-56021927
Time frame: Pre-dose up to 1344 hours post-dose
The AUC(0-24hrs) is the area under the plasma concentration-time curve from 0 to 24 hours post dosing.
Area Under the Plasma Concentration-Time Curve From 0 to 168 Hours (AUC[0-168]) Post Dose of JNJ-56021927
Time frame: Pre-dose up to 1344 hours post-dose
The AUC(0-168hrs) is the area under the plasma concentration-time curve from 0 to 168 hours post dosing.
Area Under the Plasma Concentration-Time Curve From 0 to Last Quantifiable Concentration (AUC[0-last]) Post Dose of JNJ-56021927
Time frame: Pre-dose up to 1344 hours post-dose
The AUC(0-last) is the area under the plasma concentration-time curve from 0 to time of the last quantifiable concentration.
Area Under the Plasma Concentration-Time Curve From 0 to Last Quantifiable Concentration Corrected for Unbound Fraction (AUC[last_unb]) Post Dose of JNJ-56021927
Time frame: Pre-dose up to 1344 hours post-dose
The AUC(last_unb) corrected for unbound fraction is the area under the plasma concentration-time curve from 0 to time of the last quantifiable concentration.
Area Under the Plasma Concentration-Time Curve From 0 to Infinite Time (AUC[0-infinity]) Post Dose of JNJ-56021927
Time frame: Pre-dose up to 1344 hours post-dose
The AUC (0-infinity) is the area under the plasma JNJ-56021927 concentration-time curve from time 0 to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z), in which AUC(0-last) is area under the plasma JNJ-56021927 concentration-time curve from time zero to time of the last quantifiable concentration, C(last) is the last observed quantifiable concentration and lambda(z) is elimination rate constant.
Area Under the Plasma Concentration-Time Curve From 0 to Infinite Time Corrected for Unbound Fraction (AUC[infinity_unb]) Post Dose of JNJ-56021927
Time frame: Pre-dose up to 1344 hours post-dose
The AUC(infinity_unb) is the area under the plasma JNJ-56021927 concentration-time curve from time 0 to infinite time corrected for unbound fraction, calculated as the sum of AUC (0-last) and C(last)/lambda(z), in which AUC(0-last) is area under the plasma JNJ-56021927 concentration-time curve from time zero to time of the last quantifiable concentration, C(last) is the last observed quantifiable concentration and lambda(z) is elimination rate constant.
Percentage of Area Under the Plasma Concentration-Time Curve Obtained by Extrapolation (%AUC[infinity,ex])
Time frame: Pre-dose up to 1344 hours post-dose
The %AUC[infinity,ex] is calculated by dividing the difference of AUC(0-infinity) and AUC(0-last) by AUC(0-infinity) and then multiplying by 100, (AUC[0-infinity] - AUC[0-last])*100/AUC[0-infinity].
Terminal Half-life (t[1/2]) of JNJ-56021927
Time frame: Pre-dose up to 1344 hours post-dose
Elimination half-life associated with the terminal slope Lambda (z) of the semi logarithmic drug concentration-time curve, calculated as 0.693/Lambda (z).
Elimination Rate Constant (Lambda [z]) of JNJ-56021927
Time frame: Pre-dose up to 1344 hours post-dose
The Lambda (z) determined by first-order rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
Time of Last Measurable Plasma Concentration (Tlast) of JNJ-56021927
Time frame: Pre-dose up to 1344 hours post-dose
Time to last measurable plasma concentration is evaluated.
Total Apparent Clearance (CL/F) of JNJ-56021927
Time frame: Pre-dose up to 1344 hours post-dose
The CL/F is defined as Dose/AUC (0-infinity).
Apparent Volume of Distribution (Vd/F) of JNJ-56021927
Time frame: Pre-dose up to 1344 hours post-dose
The Vd/F is defined as Dose/[Lambda (z)*AUC (0-infinity)].
Metabolite to Parent Drug Ratio for Maximum Observed Plasma Concentration (MPR Cmax)
Time frame: Pre-dose up to 1344 hours post-dose
The (MPR Cmax) is metabolite to parent drug ratio for maximum observed plasma concentration.
Metabolite to Parent Drug Ratio for Area Under the Plasma Concentration-Time Curve From Time 0 to Last Observed Quantifiable Concentration (MPR AUC[0-last])
Time frame: Pre-dose up to 1344 hours post-dose
The MPR AUClast is metabolite to parent drug ratio for area under the plasma concentration-time curve from time 0 to last quantifiable concentration (AUC [0-last]).
Metabolite to Parent Drug Ratio for Area Under the Plasma Concentration-Time Curve From Time Zero to Extrapolated Infinite Time (MPR AUC [0-infinity])
Time frame: Pre-dose up to 1344 hours post-dose
The MPR AUC [0-infinity] is metabolite to parent drug ratio for area under the plasma concentration-time curve from time zero to extrapolated infinite time (AUC [0-infinity]).
1 secondary outcome
Number of Participants with Adverse Events (AEs) and Serious AEs
Time frame: Screening up to follow-up (56 days after dose administration)
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 3 Feb 2025.
- A Single-Dose, Open-Label Study to Evaluate the Pharmacokinetics of JNJ-56021927 in Subjects With Mild or Moderate Hepatic Impairment Compared With Subjects With Normal Hepatic FunctionLink provided by the sponsor.
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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 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-56021927 in people with Hepatic Impairment, run by Aragon Pharmaceuticals, Inc. at 2 sites in United States.
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 13 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 3 Feb 2025. 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 United States. 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 Plasma Concentration (Cmax) of JNJ-56021927 (time frame: Pre-dose up to 1344 hours post-dose). The study lists 18 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 3 Feb 2025.