Status:
COMPLETED
A Study in Healthy Participants Investigating the Safety, Tolerability and Plasma Pharmacokinetics (PK) of Single Oral Doses of JNJ-47910382
Lead Sponsor:
Janssen R&D Ireland
Conditions:
Hepatitis C Virus Infection
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to investigate the safety, tolerability and plasma pharmacokinetics (PK) of JNJ-47910382 after increasing single oral doses (taken with food) from 10 mg up to 600 mg or up...
Detailed Description
This is a Phase I, single-center, first-in-human, double-blind (neither the participant nor the investigator/medical staff knows whether placebo or JNJ-47910382 is given at a certain moment), randomiz...
Eligibility Criteria
Inclusion
- Caucasian subjects between 18 and 45 years of age, inclusive.
- Japanese subjects between 20 and 45 years of age, inclusive.
- MALE Japanese subjects who has resided outside of Japan for no more than 5 years and whose parents and maternal and paternal grandparents are Japanese
- A body weight above 50 kg at screening
- Non-smoking for at least 3 months prior to screening
Exclusion
- Female Caucasian, except if postmenopausal for at least 2 years or be surgically sterile.
- Hepatitis A, B or C infection
- Human Immunodeficiency Virus Type 1 (HIV-1) or Human Immunodeficiency Virus Type 2 (HIV-2) infection
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01482611
Start Date
November 1 2011
End Date
April 1 2012
Last Update
February 20 2013
Active Locations (1)
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1
Neuss, Germany