Study to Evaluate the Pharmacokinetics, Tolerability, and Safety of ACT-128800 in Japanese and Caucasian Healthy Male and Female Subjects

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT02223832

Run by

Actelion

People needed

20

Starts

2009-02-01

Expected to finish

2009-04-01

Last updated by the study team

2014-08-22

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Hawaii Clinical Research Center — Honolulu, Hawaii, United States

Full record on ClinicalTrials.gov

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