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

NCT01202734 | Completed Phase 1

• 1 other identifier: CR017464
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

CONCERTA; Methylphenidate HCl; Pharmacokinetic; Safety; Adult; Men; Male

Outcome Measures

Primary Outcomes (1)

• Plasma concentrations of total methylphenidate HCl and its major metabolite, a-phenyl-piperidine-acetic acid (PPAA)

  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

  Day 1 of Period 1 through Day 3 of Period 3 (approximately 23 days)

Study Arms (1)

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)

Drug: Methylphenidate HCl

Interventions

Methylphenidate HCl DRUG

Period 1: One tablet, oral, 36 mg, once daily, single-dose on Day 1

001

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Study Sites (1)

Unknown Facility

Cypress, California, United States

Location

MeSH Terms

Conditions

Multiple Endocrine Neoplasia Type 1

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2010
• First Posted: September 16, 2010
• Study Start: September 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: November 1, 2010
• Last Updated: May 16, 2014

Record last verified: 2014-05

Locations

US (1)