A

• Conditions: Multi-drug resistant tuberculosis; MedDRA version: 14.1Level: PTClassification code 10044755Term: TuberculosisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2012-005492-13-NL
• Lead Sponsor: Janssen infectious diseases BVBA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-07
• Last Update Posted: 18 November 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1)Healthy participant on the basis of physical examination, medical history, vital signs, and electrocardiogram (ECG), and the results of blood biochemistry and hematology tests and a urinalysis performed at screening
2)Must have a Body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.5 to 30.0 kg/m2, extremes included
3)Women must be postmenopausal for at least 2 years
4) Men must agree to use a highly effective method of birth control (i.e., male condom with either female intrauterine device, diaphragm, cervical cap or hormone based contraceptives by their female partner) when having sexual intercourse with a female partner of childbearing potential, and to not donate sperm during the study and for 6 months after receiving the last dose of study drug. Men who have had a vasectomy and have a female partner of childbearing potential must agree to use a male condom during the study and for 6 months after receiving the last dose of study drug -Participants must be non-smokers for at least 3 months prior to screening
5) Participants must be non-smokers for at least 3 months prior to screening
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 36
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Human immunodeficiency virus – type 1 (HIV-1) or type 2 (HIV-2) infection confirmed at screening -Hepatitis A, B or C infection confirmed at screening
3) A positive urine drug test or alcohol breath test at screening. Urine will be tested for the presence of amphetamines, barbiturates, benzodiazepines, cocaine, methadone, and opioids
4) History or any currently active disease or condition that the Investigator considers to be clinically significant for which, in the opinion of the Investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified ssessments

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified