HealthyPhase 1NCT01202734
A Pharmacokinetics and Safety of Methylphenidate HCl in Healthy Japanese Adult Male Volunteers
A Phase 1 study testing Methylphenidate HCl in people with Healthy, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the pharmacokinetics and safety of 3 single doses of Methylphenidate HCl in healthy Japanese adult male volunteers. Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Methylphenidate HCl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Nov 2010
- 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 20 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) between 18.5 and 25.0 kg/m², inclusive
- Body weight of not less than 50 kg
- Supine (lying down) blood pressure between 90 and 140 mmHg systolic, inclusive, and not higher than 90 mmHg diastolic
Who cannot join
- History of or current medical illness judged by the investigator to be clinically significant
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen, within 14 days before the first dose of study drug
- History of drug or alcohol abuse within the past 5 years
- History of smoking or use of nicotine containing substances within the previous 2 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single-Ascending-Dose Study to Investigate the Pharmacokinetics and Safety of CONCERTA in Healthy Japanese Adult Male Subjects
The purpose of the study is to evaluate the pharmacokinetics and safety of 3 single doses of Methylphenidate HCl in healthy Japanese adult male volunteers.
Read the detailed description
This is an open-label (name of assigned treatment is known), single-center study of the pharmacokinetics (blood levels) and safety of 3 single doses of methylphenidate HCl administered orally (by mouth) to healthy Japanese adult male volunteers. Methylphenidate HCl is a drug that is currently approved for the treatment of adults with attention-deficit/hyperactivity disorder (ADHD) in regions outside Japan, including the United States where this study will be conducted. Volunteers will participate in the study for a maximum of 42 days. Blood samples will be collected from volunteers during the study to determine the concentration of the methylphenidate HCl in the blood after dosing. Safety will be monitored throughout the study by evaluating adverse events reported, changes in clinical laboratory test results, vital signs measurements, physical examination results, and other protocol-specified safety assessments. All volunteers will receive a single oral dose of methylphenidate HCl with 240 mL (1 cup) of noncarbonated water after at least a 10-hour fast (without eating food) during 3 treatment periods as follows: Period 1, one 36-mg tablet; Period 2, three 18-mg tablets; and Period 3, two 36-mg tablets. Treatment periods will be separated by 3 to 7 days. Volunteers will continue fasting until at least 4 hours after dosing.
- Conditions
- Healthy
- Being tested
- Methylphenidate HCl
- Keywords
- CONCERTA, Methylphenidate HCl, Pharmacokinetic, Safety, Adult, Men, Male
- Medical subject headings
- Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylphenidate HClDrug
Period 1: One tablet, oral, 36 mg, once daily, single-dose on Day 1
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | Methylphenidate HCl Period 1: One tablet oral 36 mg once daily single-dose on Day 1 Period 2: Three tablets oral 18 mg once daily single-dose on Day 1 Period 3: Two tablets oral 36 mg once daily single-dose on Day 1. (Each treatment period will be separated by 3-7 days) Receives: Drug: Methylphenidate HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations of total methylphenidate HCl and its major metabolite, a-phenyl-piperidine-acetic acid (PPAA)
Measured: At protocol-specified times on Day 1 through Day 3 in Treatment Periods 1, 2, and 3
Secondary outcomes (1)
The number and type of treatment-emergent adverse events
Measured: Day 1 of Period 1 through Day 3 of Period 3 (approximately 23 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionOct 2010
- Study completionNov 2010
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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01202734
- Sponsor's protocol ID
- CR017464
- Status last verified
- May 2014
- First submitted
- 14 Sep 2010
- Last updated
- 16 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-Ascending-Dose Study to Investigate the Pharmacokinetics and Safety of CONCERTA in Healthy Japanese Adult Male Subjects
- ClinicalTrials.gov ID
- NCT01202734
- Acronym / sponsor ID
- CR017464
- Conditions
- Healthy
- Keywords
- CONCERTA, Methylphenidate HCl, Pharmacokinetic, Safety, Adult, Men, Male
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 16 Sep 2010 (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 the study is to evaluate the pharmacokinetics and safety of 3 single doses of Methylphenidate HCl in healthy Japanese adult male volunteers.
Detailed description
This is an open-label (name of assigned treatment is known), single-center study of the pharmacokinetics (blood levels) and safety of 3 single doses of methylphenidate HCl administered orally (by mouth) to healthy Japanese adult male volunteers. Methylphenidate HCl is a drug that is currently approved for the treatment of adults with attention-deficit/hyperactivity disorder (ADHD) in regions outside Japan, including the United States where this study will be conducted. Volunteers will participate in the study for a maximum of 42 days. Blood samples will be collected from volunteers during the study to determine the concentration of the methylphenidate HCl in the blood after dosing. Safety will be monitored throughout the study by evaluating adverse events reported, changes in clinical laboratory test results, vital signs measurements, physical examination results, and other protocol-specified safety assessments. All volunteers will receive a single oral dose of methylphenidate HCl with 240 mL (1 cup) of noncarbonated water after at least a 10-hour fast (without eating food) during 3 treatment periods as follows: Period 1, one 36-mg tablet; Period 2, three 18-mg tablets; and Period 3, two 36-mg tablets. Treatment periods will be separated by 3 to 7 days. Volunteers will continue fasting until at least 4 hours after dosing.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: Methylphenidate HClMethylphenidate HCl Period 1: One tablet oral 36 mg once daily single-dose on Day 1 Period 2: Three tablets oral 18 mg once daily single-dose on Day 1 Period 3: Two tablets oral 36 mg once daily single-dose on Day 1. (Each treatment period will be separated by 3-7 days) |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index (BMI) between 18.5 and 25.0 kg/m², inclusive
- Body weight of not less than 50 kg
- Supine (lying down) blood pressure between 90 and 140 mmHg systolic, inclusive, and not higher than 90 mmHg diastolic
Key exclusion criteria (4 listed)
- History of or current medical illness judged by the investigator to be clinically significant
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen, within 14 days before the first dose of study drug
- History of drug or alcohol abuse within the past 5 years
- History of smoking or use of nicotine containing substances within the previous 2 months
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 |
|---|---|---|
| Methylphenidate HClPeriod 1: One tablet, oral, 36 mg, once daily, single-dose on Day 1 | Drug | 001 |
Primary outcome
Plasma concentrations of total methylphenidate HCl and its major metabolite, a-phenyl-piperidine-acetic acid (PPAA)
Time frame: At protocol-specified times on Day 1 through Day 3 in Treatment Periods 1, 2, and 3
1 secondary outcome
The number and type of treatment-emergent adverse events
Time frame: Day 1 of Period 1 through Day 3 of Period 3 (approximately 23 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 May 2014.
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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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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 Methylphenidate HCl in people with Healthy, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. 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 3 inclusion and 4 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 May 2014. 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?
Plasma concentrations of total methylphenidate HCl and its major metabolite, a-phenyl-piperidine-acetic acid (PPAA) (time frame: At protocol-specified times on Day 1 through Day 3 in Treatment Periods 1, 2, and 3). 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 May 2014.