A Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK2336805 Alone and With the Co-administration of TMC435 in Healthy Japanese Participants.
Completed · Phase 1
Conditions studied: Healthy
In brief
The purpose of the study is to investigate the safety, tolerability, and pharmacokinetic (what the body does to a medication) of GSK2336805 alone and with the co-administration of TMC435 in healthy Japanese participants.
Key facts
- Study ID
- NCT02018536
- Run by
- Janssen R&D Ireland
- People needed
- 48
- Starts
- 2013-10-01
- Expected to finish
- 2014-03-01
- Last updated by the study team
- 2014-06-17
Who can join
Age: 20 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy Japanese participants on the basis of medical history, physical examination, vital signs, triplicate 12-lead electrocardiogram, and clinical laboratory testing performed at screening
- Must have signed an Informed Consent Form (ICF) indicating they understand the purpose of and procedures required for the study
- Must be willing to adhere to the prohibitions and restrictions specified in the protocol
- Women must be of non-childbearing potential (postmenopausal for at least 2 years or surgically sterile)
- Women, except for postmenopausal women, should have a negative serum b-human chorionic gonadotropin (hCG) pregnancy test at screening
You may not qualify if…
- History or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use within the past one year
- Participants with hepatitis A, B, or C infection or human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection at study screening
- Female participants who are breastfeeding at screening
- History of liver or renal impairment; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances
- Participants with known allergies, hypersensitivity, or intolerance to GSK2336805, TMC435 or excipients of the drug products used
Where it is running
- Study site — Cypress, California, United States
Full record on ClinicalTrials.gov
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