HealthyPhase 1NCT01690286
Effect of Ketoconazole on the Pharmacokinetics of JNJ-38518168 in Healthy Volunteers
A Phase 1 study testing JNJ-38518168 3 mg, JNJ-38518168 30 mg and JNJ-38518168 10 mg in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effects of repeated twice-daily administration of 200 mg ketoconazole on the steady-state pharmacokinetics of JNJ-38518168. 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-38518168 3 mg, JNJ-38518168 30 mg and JNJ-38518168 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Dec 2012
- 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
- Signed informed consent document indicating that the participant understands the purpose of and procedures required for the study and is willing to participate in the study
- If a woman, must be postmenopausal, surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before, throughout, and for 3 months after the study
- If a man, must agree to use an adequate contraception method, or partner using effective contraception, and to not donate sperm during the study and for 3 months after the study
- Body mass index (BMI; weight [kg]/height2 [m]2) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg
- Blood pressure between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
- Non-smoker
Who cannot join
- History of or current clinically significant medical illness, condition or disease that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- Clinically significant abnormal lab results at screening or at admission to the study center
- Clinically significant abnormal physical examination or electrocardiogram (ECG) at screening or at admission to the study center
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen and oral contraceptives and hormonal replacement therapy within 14 days before the first dose of study drug is scheduled
- Has a history of malignancy (the tendency of a medical condition, especially tumors, to become progressively worse) within the previous 5 years before screening (certain less serious malignancies during the previous 5 years, such as basal cell carcinoma of the skin which has been adequately treated, may be allowed by the study doctor)
- Donated blood or had a substantial loss of blood within 3 months before first administration of study drug
- Pregnant or currently breast-feeding
- Smoking or using nicotine-containing products within 3 months of screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Study to Assess the Effects of Repeated Twice-Daily Doses of Ketoconazole on the Steady-State Pharmacokinetics of JNJ-38518168 in Healthy Subjects
The purpose of this study is to evaluate the effects of repeated twice-daily administration of 200 mg ketoconazole on the steady-state pharmacokinetics of JNJ-38518168.
Read the detailed description
This is an open-label (all people know the identity of the intervention), single-sequence, randomized (dose of JNJ-38518168 (3 mg or 30 mg) is assigned by chance), single-center, multiple-dose study designed to assess the potential effects of multiple oral administration of ketoconazole (KTZ) on the steady-state (a situation where the overall intake of a drug is in equilibrium with its elimination) pharmacokinetics of JNJ-38518168. Pharmacokinetics (PK) explores how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time. The study consists of 3 phases: a Screening Phase of approximately 3 weeks (Days -22 to -2); an Open-Label Phase (Days -1 to 26); and a Follow-up Phase occurring from 7 to 10 days after the last dose of study drug. Participants will be randomly assigned to receive either a daily dose of 3 mg JNJ-38518168 (Group 1) or a daily dose of 30 mg JNJ-38518168 (Group 2) orally administered for 25 days. All participants will receive multiple oral doses of KTZ (200 mg every 12 hours for both Groups 1 and 2) from Day 22 through Day 25. An optional group of participants receiving 10 mg once daily of JNJ-38518168 (Group 3) may be evaluated if the data from Groups 1 and 2 do not allow the sponsor to estimate sufficiently the interaction between KTZ and daily dose of 10 mg JNJ-38518168. The participants will receive an oral dose of the study drugs in the morning of specified days, after an overnight fast for at least 10 hours. Blood samples will be collected at various times throughout the study for evaluation of drug concentrations in plasma. Safety will be assessed by reporting of adverse events, vital signs, physical examination results, weight, and electrocardiogram (ECG) evaluations. Participants will leave the study center on Day 26 after the collection of the last scheduled PK blood sample. For each participant, a follow-up visit will occur 7 to 10 days after the last dose of study drug. For each participant, the total duration of the study is approximately 8 weeks.
- Conditions
- Healthy
- Being tested
- JNJ-38518168 3 mg, JNJ-38518168 30 mg, JNJ-38518168 10 mg, Ketoconazole 200 mg
- Keywords
- Healthy, Ketoconazole, JNJ-38518168, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-38518168 3 mgDrug
One oral daily dose of JNJ-38518168 3 mg for 25 days.
JNJ-38518168 30 mgDrug
One oral daily dose of JNJ-38518168 30 mg for 25 days.
JNJ-38518168 10 mgDrug
One oral daily dose of JNJ-38518168 10 mg for 25 days.
Ketoconazole 200 mgDrug
Oral doses of ketoconazole 200 mg every 12 hours, from Day 22 through Day 25.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: JNJ-38518168 3 mg/ ketoconazole | Experimental | Not described Receives: Drug: JNJ-38518168 3 mg; Drug: Ketoconazole 200 mg |
| Group 2: JNJ-38518168 30 mg/ ketoconazole | Experimental | Not described Receives: Drug: JNJ-38518168 30 mg; Drug: Ketoconazole 200 mg |
| Group 3: JNJ-38518168 10 mg/ ketoconazole (optional) | Experimental | Not described Receives: Drug: JNJ-38518168 10 mg; Drug: Ketoconazole 200 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The plasma concentrations of JNJ-38518168
Measured: From Day 13 up to Day 26
The plasma concentrations of ketoconazole
Measured: Day 25
Secondary outcomes (1)
The time to attain steady-state pharmacokinetics following JNJ-38518168 once daily doses for 21 consecutive days
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2012
- Study completionDec 2012
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 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
- NCT01690286
- Sponsor's protocol ID
- CR100915
- Other IDs
- 38518168ARA1003
- Status last verified
- Jul 2013
- First submitted
- 19 Sep 2012
- Last updated
- 16 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Assess the Effects of Repeated Twice-Daily Doses of Ketoconazole on the Steady-State Pharmacokinetics of JNJ-38518168 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01690286
- Acronym / sponsor ID
- CR100915
- Conditions
- Healthy
- Keywords
- Healthy, Ketoconazole, JNJ-38518168, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 21 Sep 2012 (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 evaluate the effects of repeated twice-daily administration of 200 mg ketoconazole on the steady-state pharmacokinetics of JNJ-38518168.
Detailed description
This is an open-label (all people know the identity of the intervention), single-sequence, randomized (dose of JNJ-38518168 (3 mg or 30 mg) is assigned by chance), single-center, multiple-dose study designed to assess the potential effects of multiple oral administration of ketoconazole (KTZ) on the steady-state (a situation where the overall intake of a drug is in equilibrium with its elimination) pharmacokinetics of JNJ-38518168. Pharmacokinetics (PK) explores how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time. The study consists of 3 phases: a Screening Phase of approximately 3 weeks (Days -22 to -2); an Open-Label Phase (Days -1 to 26); and a Follow-up Phase occurring from 7 to 10 days after the last dose of study drug. Participants will be randomly assigned to receive either a daily dose of 3 mg JNJ-38518168 (Group 1) or a daily dose of 30 mg JNJ-38518168 (Group 2) orally administered for 25 days. All participants will receive multiple oral doses of KTZ (200 mg every 12 hours for both Groups 1 and 2) from Day 22 through Day 25. An optional group of participants receiving 10 mg once daily of JNJ-38518168 (Group 3) may be evaluated if the data from Groups 1 and 2 do not allow the sponsor to estimate sufficiently the interaction between KTZ and daily dose of 10 mg JNJ-38518168. The participants will receive an oral dose of the study drugs in the morning of specified days, after an overnight fast for at least 10 hours. Blood samples will be collected at various times throughout the study for evaluation of drug concentrations in plasma. Safety will be assessed by reporting of adverse events, vital signs, physical examination results, weight, and electrocardiogram (ECG) evaluations. Participants will leave the study center on Day 26 after the collection of the last scheduled PK blood sample. For each participant, a follow-up visit will occur 7 to 10 days after the last dose of study drug. For each participant, the total duration of the study is approximately 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: JNJ-38518168 3 mg/ ketoconazole | Experimental | Drug: JNJ-38518168 3 mg, Drug: Ketoconazole 200 mg |
| Group 2: JNJ-38518168 30 mg/ ketoconazole | Experimental | Drug: JNJ-38518168 30 mg, Drug: Ketoconazole 200 mg |
| Group 3: JNJ-38518168 10 mg/ ketoconazole (optional) | Experimental | Drug: JNJ-38518168 10 mg, Drug: Ketoconazole 200 mg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Signed informed consent document indicating that the participant understands the purpose of and procedures required for the study and is willing to participate in the study
- If a woman, must be postmenopausal, surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before, throughout, and for 3 months after the study
- If a man, must agree to use an adequate contraception method, or partner using effective contraception, and to not donate sperm during the study and for 3 months after the study
- Body mass index (BMI; weight [kg]/height2 [m]2) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg
- Blood pressure between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
Key exclusion criteria (8 listed)
- History of or current clinically significant medical illness, condition or disease that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- Clinically significant abnormal lab results at screening or at admission to the study center
- Clinically significant abnormal physical examination or electrocardiogram (ECG) at screening or at admission to the study center
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen and oral contraceptives and hormonal replacement therapy within 14 days before the first dose of study drug is scheduled
- Has a history of malignancy (the tendency of a medical condition, especially tumors, to become progressively worse) within the previous 5 years before screening (certain less serious malignancies during the previous 5 years, such as basal cell carcinoma of the skin which has been adequately treated, may be allowed by the study doctor)
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-38518168 3 mgOne oral daily dose of JNJ-38518168 3 mg for 25 days. | Drug | Group 1: JNJ-38518168 3 mg/ ketoconazole |
| JNJ-38518168 30 mgOne oral daily dose of JNJ-38518168 30 mg for 25 days. | Drug | Group 2: JNJ-38518168 30 mg/ ketoconazole |
| JNJ-38518168 10 mgOne oral daily dose of JNJ-38518168 10 mg for 25 days. | Drug | Group 3: JNJ-38518168 10 mg/ ketoconazole (optional) |
| Ketoconazole 200 mgOral doses of ketoconazole 200 mg every 12 hours, from Day 22 through Day 25. | Drug | Group 1: JNJ-38518168 3 mg/ ketoconazole, Group 2: JNJ-38518168 30 mg/ ketoconazole, Group 3: JNJ-38518168 10 mg/ ketoconazole (optional) |
Primary outcome
The plasma concentrations of JNJ-38518168
Time frame: From Day 13 up to Day 26
The plasma concentrations of ketoconazole
Time frame: Day 25
1 secondary outcome
The time to attain steady-state pharmacokinetics following JNJ-38518168 once daily doses for 21 consecutive days
Time frame: 21 days
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 16 Jul 2013.
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-38518168 3 mg, JNJ-38518168 30 mg and JNJ-38518168 10 mg in people with Healthy, run by Janssen Research & Development, LLC at 1 site 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 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 16 Jul 2013. 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 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?
The plasma concentrations of JNJ-38518168 (time frame: From Day 13 up to Day 26). 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 16 Jul 2013.