A Pharmacokinetic Study to Assess the Effect of Food in Healthy Male Participants Receiving TMC435

NCT01799603 | Completed Phase 1

• 2 other identifiers: CR100854TMC435HPC1007
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the effect of food on the pharmacokinetics (explores what the body does to the drug) and safety of TMC435 in Japanese healthy adult male participants.

Conditions

Healthy

Keywords

Healthy; TMC435; G008

Outcome Measures

Primary Outcomes (2)

• Maximum Plasma Concentration (C[max])

  The C(max) is the maximum plasma concentration.

  -3 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose on Day 1

• Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[infinity])

  The AUC (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; and C (last) is the last observed quantifiable concentration; and lambda (z) is elimination rate constant.

  -3 hours (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post-dose on Day 1

Study Arms (2)

TMC435 in fasted then fed condition

EXPERIMENTAL

Participants under fasting condition will be administered with TMC435, 100 milligram (mg) as oral capsule on Day 1 of first treatment period and then will be administered with TMC435, 100 mg oral capsule on Day 1 under fed condition of second treatment period (after washout period of 9 days, between the two treatment periods).

Drug: TMC435

TMC435 in fed then fasted condition

EXPERIMENTAL

Participants under fed condition will be administered with TMC435, 100 milligram (mg) as oral capsule on Day 1 of first treatment period and then will be administered with TMC435, 100 mg oral capsule on Day 1 under fasting condition of second treatment period (after washout period of 9 days, between the two treatment periods).

Drug: TMC435

Interventions

TMC435 DRUG

TMC435, 100 milligram oral capsule will be administered on Day 1 of each treatment period, separated by washout period of 9 days.

Also known as: G008

TMC435 in fasted then fed condition; TMC435 in fed then fasted condition

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Be a Japanese man aged 20 to 40 years, inclusive at the day of informed consent being signed
• Must agree to use an adequate contraception method (for example, double-barrier method) as deemed appropriate by the Investigators during the study and for 3 months after receiving the last dose of study drug
• Body mass index (BMI) between 18.5 and 25.0 kilogram per square meter (kg/m\^2) and body weight not less than 50 kilogram
• Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic
• Non-smoker or participant who has quitted any tobacco or nicotine containing products more than one year prior to screening

You may not qualify if:

• History of or current clinically significant medical illness including (but not limited to), cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the Investigator considers should exclude the participant or that could interfere with the interpretation of the study results
• Use of any prescription or non-prescription medication (including vitamins and supplements) within 14 days before the administration on Day 1 of treatment Period 1
• History of drug or alcohol abuse within the past 5 years and positive test for drugs of abuse, such as cannabinoids, opiates, cocaine, amphetamines, benzodiazepines or barbiturates and serum alcohol test
• Known allergy to the study drug or any of the excipients of the formulation
• Participated in another clinical study and received another study drugs administration or used an experimental medical device within 120 days or within a period less than 10 times the drug's half life, whichever is longer, before Day 1 of the first treatment period

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Unknown Facility

Toshima City, Japan

Location

MeSH Terms

Interventions

Simeprevir

Intervention Hierarchy (Ancestors)

Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2013
• First Posted: February 27, 2013
• Study Start: May 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: April 29, 2013

Record last verified: 2013-04

Locations

JP (1)