HealthyPhase 1NCT02455856
Study to Investigate Effects of Repeated Administration of Itraconazole on Pharmacokinetics of JNJ-42847922 in Healthy Male Participants
A Phase 1 study testing JNJ-42847922 and Itraconazole in people with Healthy, run by Janssen Cilag N.V./S.A. at 1 site in Germany.
Trial summary
The purpose of this study is to assess the effects of repeated once daily administration of 200 milligram (mg) of itraconazole (steady state) on the single-dose pharmacokinetics of JNJ 42847922 in healthy, male participants. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- JNJ-42847922 and Itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- 18 May 2015to 19 Jun 2015
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male participants aged between 18 and 55 years, inclusive
- Body mass index (BMI) between 18 and 30 kilogram/meter^2 inclusive (BMI = weight/height^2)
- Nonsmoker (not smoked for at least 3 months prior to screening)
- Men who are sexually active with a woman of childbearing potential and have not had a vasectomy must agree to use a barrier method of birth control e.g., either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 3 months after receiving the last dose of study drug. In addition, their female partners should also use an appropriate method of birth control for at least the same duration
- Participants must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study and comply with the study procedures and restrictions
Who cannot join
- Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or admission
- Clinically significant abnormal physical examination, vital signs or 12-lead ECG at screening, on Day -1 or on Day 1, predose
- History of or current significant psychiatric and other illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematological disease, lipid abnormalities, bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, Parkinson's disease, infection, or any other illness that the Investigator considers should exclude the subject. History of epilepsy or fits or unexplained black-outs
- Serology positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies (HCV) or human immunodeficiency virus (HIV) antibodies
- History of clinically significant drug and/or food allergies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Investigate the Potential Effects of Repeated Administration of Itraconazole on the Pharmacokinetics of JNJ-42847922 in Healthy Male Subjects
The purpose of this study is to assess the effects of repeated once daily administration of 200 milligram (mg) of itraconazole (steady state) on the single-dose pharmacokinetics of JNJ 42847922 in healthy, male participants.
Read the detailed description
This is an open-label (all people know the identity of the intervention), fixed-sequence, single-center, single-dose study designed to assess the effects of steady-state itraconazole exposure on the pharmacokinetics of a single oral dose of JNJ 42847922 in healthy male participants. The duration of study will be approximately of 6 weeks per participant. The study consists of 3 parts: Screening (that is, 21 days before study commences on Day 1); Open-label Treatment (6 days); and Follow-up (7 to 14 days after last dose of study drug or early withdrawal).
All eligible participants will receive single oral doses of 5 milligram (mg) JNJ-42847922 on Day 1 and Day 6. A daily dose of 200 mg itraconazole will be administered from Day 2 to Day 6. Followed by an overnight fast of at least 8 hours participants will be administered with study treatment 30 minutes after light breakfast. Participants will not be allowed to have food until 4 hours of drug administration. Blood samples will be collected for evaluation of pharmacokinetics at pre-dose and post-dose of study treatment. Participants' safety will be monitored throughout the study.
- Conditions
- Healthy
- Being tested
- JNJ-42847922, Itraconazole
- Keywords
- Healthy, Itraconazole, JNJ-42847922
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-42847922Drug
Participants will receive single dose of 5 milligram (mg) JNJ-42847922 as 5 mg/milliliter [mL] oral solution on Day 1 and Day 6.
ItraconazoleDrug
Participants will receive single dose of itraconazole as 200 mg (2*100 mg capsule) from Day 2 to Day 6.
| Study group | Role | What they receive |
|---|---|---|
| JNJ-42847922 plus Itraconazole | Experimental | Participants will receive single dose of 5 milligram (mg) JNJ-42847922 as 5 mg/milliliter [mL] oral solution on Day 1 and Day 6 and itraconazole as 200 mg (2*100 mg capsule) from Day 2 to Day 6. Receives: Drug: JNJ-42847922; Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) of JNJ-42847922
The Cmax is the maximum plasma concentration.
Measured: up to Day 6
Time to Reach Maximum Concentration (tmax) of JNJ-42847922
The tmax is time to reach the maximum observed plasma concentration.
Measured: up to Day 6
Time to Reach Last Quantifiable Plasma Concentration (tlast) of JNJ-42847922
The tmax is time to last observed quantifiable plasma concentration.
Measured: up to Day 6
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) of JNJ-42847922
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.
Measured: up to Day 6
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-42847922
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z), wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time; C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.
Measured: up to Day 6
Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC [0-24]) of JNJ-42847922
The AUC (0-24) is the area under the plasma concentration-time curve from time 0 to time 24 hours
Measured: up to Day 6
Elimination Half-Life (t [1/2] Lambda) of JNJ-42847922
Elimination half-life (t [1/2] Lambda) is associated with the terminal slope (lambda [z]) of the semi logarithmic drug concentration-time curve, calculated as 0.693/lambda(z).
Measured: up to Day 6
Rate Constant (Lambda[z])
Lambda(z) is 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: up to Day 6
Apparent total body clearance (CL/F) of JNJ-42847922
Clearance is a quantitative measure of the rate at which a drug substance is removed from the body. The CL/F will be calculated by dividing the dose by AUC (0-infinity)
Measured: up to Day 6
Apparent volume of distribution at the terminal Phase (Vd[z] /F) of JNJ-42847922
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.The Vd(z)/F will be calculated by dividing CL/F by lambda(z).
Measured: up to Day 6
Mean Residence Time of JNJ-42847922
Mean residence time, calculated as area under the first moment curve (AUMC[0-infinity]/AUC(0-infinity).
Measured: up to Day 6
Amount of JNJ-42847922 Excreted in Urine (Ae)
amount excreted into the urine, calculated by multiplying the urinary volume with the urinary concentration.
Measured: up to Day 6
Percentage of JNJ-42847922 Dose Excreted in Urine
Amount excreted into the urine, expressed as a percentage of the administered dose, calculated as [Ae/dose]*100, and corrected for molecular weight when necessary.
Measured: up to Day 6
Renal Clearance
Renal clearance calculated as Ae (total)/AUC (infinity).
Measured: up to Day 6
Secondary outcomes (1)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was 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. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: up to End of study (7 to 14 days after lasr dose of study drug or early withdrawal)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study start18 May 2015
- Primary completion19 Jun 2015
- Study completion19 Jun 2015
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.
- 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Cilag N.V./S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02455856
- Sponsor's protocol ID
- CR107144
- Other IDs
- 42847922EDI1005, 2014-005499-27, 2014
- Status last verified
- Jul 2017
- First submitted
- 26 May 2015
- Last updated
- 11 Jul 2017
- 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 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Investigate the Potential Effects of Repeated Administration of Itraconazole on the Pharmacokinetics of JNJ-42847922 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02455856
- Acronym / sponsor ID
- CR107144
- Conditions
- Healthy
- Keywords
- Healthy, Itraconazole, JNJ-42847922
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Janssen Cilag N.V./S.A.Industry (pharma, biotech, devices)
- Study start
- 18 May 2015 (actual)
- Primary completion
- 19 Jun 2015 (actual)
- Study completion
- 19 Jun 2015 (actual)
- First posted
- 28 May 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 assess the effects of repeated once daily administration of 200 milligram (mg) of itraconazole (steady state) on the single-dose pharmacokinetics of JNJ 42847922 in healthy, male participants.
Detailed description
This is an open-label (all people know the identity of the intervention), fixed-sequence, single-center, single-dose study designed to assess the effects of steady-state itraconazole exposure on the pharmacokinetics of a single oral dose of JNJ 42847922 in healthy male participants. The duration of study will be approximately of 6 weeks per participant. The study consists of 3 parts: Screening (that is, 21 days before study commences on Day 1); Open-label Treatment (6 days); and Follow-up (7 to 14 days after last dose of study drug or early withdrawal).
All eligible participants will receive single oral doses of 5 milligram (mg) JNJ-42847922 on Day 1 and Day 6. A daily dose of 200 mg itraconazole will be administered from Day 2 to Day 6. Followed by an overnight fast of at least 8 hours participants will be administered with study treatment 30 minutes after light breakfast. Participants will not be allowed to have food until 4 hours of drug administration. Blood samples will be collected for evaluation of pharmacokinetics at pre-dose and post-dose of study treatment. 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-42847922 plus Itraconazole | Experimental | Drug: JNJ-42847922, Drug: ItraconazoleParticipants will receive single dose of 5 milligram (mg) JNJ-42847922 as 5 mg/milliliter [mL] oral solution on Day 1 and Day 6 and itraconazole as 200 mg (2*100 mg capsule) from Day 2 to Day 6. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male participants aged between 18 and 55 years, inclusive
- Body mass index (BMI) between 18 and 30 kilogram/meter^2 inclusive (BMI = weight/height^2)
- Nonsmoker (not smoked for at least 3 months prior to screening)
- Men who are sexually active with a woman of childbearing potential and have not had a vasectomy must agree to use a barrier method of birth control e.g., either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 3 months after receiving the last dose of study drug. In addition, their female partners should also use an appropriate method of birth control for at least the same duration
- Participants must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study and comply with the study procedures and restrictions
Key exclusion criteria (5 listed)
- Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or admission
- Clinically significant abnormal physical examination, vital signs or 12-lead ECG at screening, on Day -1 or on Day 1, predose
- History of or current significant psychiatric and other illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematological disease, lipid abnormalities, bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, Parkinson's disease, infection, or any other illness that the Investigator considers should exclude the subject. History of epilepsy or fits or unexplained black-outs
- Serology positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies (HCV) or human immunodeficiency virus (HIV) antibodies
- History of clinically significant drug and/or food allergies
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-42847922Participants will receive single dose of 5 milligram (mg) JNJ-42847922 as 5 mg/milliliter [mL] oral solution on Day 1 and Day 6. | Drug | JNJ-42847922 plus Itraconazole |
| ItraconazoleParticipants will receive single dose of itraconazole as 200 mg (2*100 mg capsule) from Day 2 to Day 6. | Drug | JNJ-42847922 plus Itraconazole |
Primary outcome
Maximum Plasma Concentration (Cmax) of JNJ-42847922
Time frame: up to Day 6
The Cmax is the maximum plasma concentration.
Time to Reach Maximum Concentration (tmax) of JNJ-42847922
Time frame: up to Day 6
The tmax is time to reach the maximum observed plasma concentration.
Time to Reach Last Quantifiable Plasma Concentration (tlast) of JNJ-42847922
Time frame: up to Day 6
The tmax is time to last observed quantifiable plasma concentration.
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) of JNJ-42847922
Time frame: up to Day 6
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-42847922
Time frame: up to Day 6
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z), wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time; C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.
Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC [0-24]) of JNJ-42847922
Time frame: up to Day 6
The AUC (0-24) is the area under the plasma concentration-time curve from time 0 to time 24 hours
Elimination Half-Life (t [1/2] Lambda) of JNJ-42847922
Time frame: up to Day 6
Elimination half-life (t [1/2] Lambda) is associated with the terminal slope (lambda [z]) of the semi logarithmic drug concentration-time curve, calculated as 0.693/lambda(z).
Rate Constant (Lambda[z])
Time frame: up to Day 6
Lambda(z) is 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.
Apparent total body clearance (CL/F) of JNJ-42847922
Time frame: up to Day 6
Clearance is a quantitative measure of the rate at which a drug substance is removed from the body. The CL/F will be calculated by dividing the dose by AUC (0-infinity)
Apparent volume of distribution at the terminal Phase (Vd[z] /F) of JNJ-42847922
Time frame: up to Day 6
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.The Vd(z)/F will be calculated by dividing CL/F by lambda(z).
Mean Residence Time of JNJ-42847922
Time frame: up to Day 6
Mean residence time, calculated as area under the first moment curve (AUMC[0-infinity]/AUC(0-infinity).
Amount of JNJ-42847922 Excreted in Urine (Ae)
Time frame: up to Day 6
amount excreted into the urine, calculated by multiplying the urinary volume with the urinary concentration.
Percentage of JNJ-42847922 Dose Excreted in Urine
Time frame: up to Day 6
Amount excreted into the urine, expressed as a percentage of the administered dose, calculated as [Ae/dose]*100, and corrected for molecular weight when necessary.
Renal Clearance
Time frame: up to Day 6
Renal clearance calculated as Ae (total)/AUC (infinity).
1 secondary outcome
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: up to End of study (7 to 14 days after lasr dose of study drug or early withdrawal)
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 11 Jul 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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-42847922 and Itraconazole in people with Healthy, run by Janssen Cilag N.V./S.A. at 1 site in Germany.
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 11 Jul 2017. 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 Germany. 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-42847922 (time frame: up to Day 6). The study lists 14 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 11 Jul 2017.