Study to Evaluate the Pharmacokinetics, Tolerability, and Safety of ACT-128800 in Japanese and Caucasian Healthy Male and Female Subjects
Study to Evaluate the Pharmacokinetics, Tolerability, and Safety of ACT-128800 in Japanese and Caucasian Healthy Male and Female Subjects
This is a study to evaluate the relative pharmacokinetic properties and the tolerability and
 safety of ACT-128800 in Japanese and Caucasian healthy male and female subjects after
 single-dose administration.
10 Japanese and 10 Caucasian healthy male and female subjects in a one to one male to female
 ratio will be included in the study. Japanese and Caucasian subjects will be matched for body
 weight.
Inclusion Criteria:

 -  Signed informed consent prior to any study-mandated procedure.

 -  Japanese or Caucasian. (Japanese subjects: both parents of the subject are Japanese
 [born in Japan]. Caucasian subjects: both parents of the subject are Caucasian).

 -  Body mass index between 18 and 28 kg/m^2, inclusive.

 -  Women not of childbearing potential:

 -  Women of childbearing potential must have a negative serum pregnancy test at screening
 and a negative urine pregnancy test prior to drug intake on Day 1; use a reliable
 method of contraception and continue this contraception for the duration of the study
 and for at least 2 months after study drug intake. In addition, her partner must use a
 condom.

 -  Systolic blood pressure 100-145 mmHg, diastolic blood pressure 50-90 mmHg, and heart
 rate (HR) 50-95 beats per minute (inclusive).

 -  12-lead electrocardiogram without clinically relevant abnormalities at screening.

 -  Hematology and clinical chemistry results not deviating from the normal range to a
 clinically relevant extent at screening.

 -  Negative results from urine drug screen at screening.

 -  Ability to communicate well with the Investigator (if necessary with the help of an
 interpreter) and to understand and comply with the requirements of the study.

 Exclusion Criteria:

 -  Electrocardiograph PQ/PR interval (time interval from the beginning of the P wave to
 the beginning of the QRS complex) > 200 milliseconds at screening.

 -  Nursing woman.

 -  History of asthma or chronic obstructive pulmonary disease.

 -  Known hypersensitivity to any excipients of the drug formulation.

 -  Treatment with another investigational drug within 3 months prior to screening.

 -  Excessive caffeine consumption, defined as > 800 mg per day at screening.

 -  History or clinical evidence of any disease and/or existence of any surgical or
 medical condition that might interfere with the absorption, distribution, metabolism
 or excretion of the study drug.

 -  Any cardiac condition or illness, including ECG abnormalities, with a potential to
 increase the cardiac risk of the subject.

 -  Smoking within the last month prior to screening.

 -  Any immunosuppressive treatment within 6 weeks before study drug administration.

 -  Previous treatment with any prescribed or over-the-counter medications within 2 weeks
 prior to screening.

 -  Loss of 250 mL or more of blood within 3 months prior to screening.

 -  Lymphopenia (< 1,000 lymphocytes/μL).

 -  Viral, fungal, bacterial or protozoal infection within 4 weeks before study drug
 administration.

 -  Positive results from the hepatitis serology, except for vaccinated subjects, at
 screening.

 -  Positive results from human immunodeficiency vrus serology at screening.

 -  Legal incapacity or limited legal capacity at screening.

 -  History of alcoholism or drug abuse.

 -  Any circumstances or conditions, which, in the opinion of the investigator, may affect
 full participation in the study or compliance with the protocol.