A Pharmacokinetics and Safety of Methylphenidate HCl in Healthy Japanese Adult Male Volunteers

May 15, 2014 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 001
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)
Drug: Methylphenidate HCl
Period 1: One tablet, oral, 36 mg, once daily, single-dose on Day 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
At protocol-specified times on Day 1 through Day 3 in Treatment Periods 1, 2, and 3

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
Day 1 of Period 1 through Day 3 of Period 3 (approximately 23 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

September 14, 2010

First Submitted That Met QC Criteria

September 14, 2010

First Posted (Estimate)

September 16, 2010

Study Record Updates

Last Update Posted (Estimate)

May 16, 2014

Last Update Submitted That Met QC Criteria

May 15, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR017464

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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