Status:
COMPLETED
Study to Evaluate the Pharmacokinetics, Tolerability, and Safety of ACT-128800 in Japanese and Caucasian Healthy Male and Female Subjects
Lead Sponsor:
Actelion
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
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 administr...
Detailed Description
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02223832
Start Date
February 1 2009
End Date
April 1 2009
Last Update
August 22 2014
Active Locations (1)
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1
Hawaii Clinical Research Center
Honolulu, Hawaii, United States, 96813