Overview

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ALS-008176 in Healthy Japanese Adult Participants

Status:
Completed
Trial end date:
2015-07-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ALS-008176 following oral administration of single ascending dose of ALS-008176 in healthy Japanese adult participants.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Janssen Pharmaceutical K.K.
Criteria
Inclusion Criteria:

- Be a Japanese participant whose parents and grandparents are Japanese as determined by
the participant's verbal report

- Each participant must sign an Informed Consent Form (ICF) indicating that he or she
understands the purpose of and procedures required for the study and are willing to
participate in the study

- Participant must be willing and able to adhere to the prohibitions and restrictions
specified in this protocol

- A female participant must be either:

1. Not of childbearing potential: postmenopausal [greater than (>) 45 years of age
with amenorrhea for at least 2 years, or any age with amenorrhea for at least 6
months and a serum follicle stimulating hormone (FSH) level >40 International
Units (IU)/ liter (L) (to be confirmed at Screening for all postmonopausal
women)] OR

2. Permanently sterilized (eg, bilateral tubal occlusion [which includes tubal
ligation procedures as consistent with local regulations], hysterectomy,
bilateral salpingectomy, bilateral oophorectomy) or otherwise incapable of
becoming pregnant, OR c. If of childbearing potential and heterosexually active,
practicing an effective method of birth control before entry and agree to
continue to use two effective methods of contraception throughout the study and
for at least 30 days after receiving the study drug

- Participant must be a non-smoker for at least one month prior to screening

Exclusion Criteria:

- Participant has a history of 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, hepatic or renal 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

- Participant with a past history of heart arrhythmias (extrasystoli, tachycardia at
rest), history of risk factors for Torsade de Pointes syndrome (eg, hypokalemia,
family history of long QT Syndrome)

- Participant has creatinine clearance of lower than 70 millilitre (mL)/min

- Participant has taken any disallowed therapies as noted in protocol, Pre-study and
Concomitant Therapy before the planned study drug

- Participant has a history of human immunodeficiency virus (HIV) antibody positive, or
tests positive for HIV at screening