A randomized, single-blinded, 3-way cross-over trial to investigate the pharmacokinetics of sustained release cysteamine bitartrate (PO-001) in healthy adult volunteers.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 9

Inclusion Criteria

Subjects must meet all of the following criteria to be considered eligible to
participate in the study:
1. Healthy male, and 18-55 years of age (inclusive);
2. Body Mass Index between 18 and 27 kg/m2 (inclusive) and body weight minimal
50 kg (inclusive);
3. Ability to read and understand the written consent form, complete
study-related procedures, and communicate with the study staff;
4. All males must practice effective contraception during the study and be
willing and able to continue contraception for at least 90 days after their
last dose of study treatment;
5. Subjects must be able to swallow the drug-administered capsules with the
capsule intact;
6. Willingness to comply with study restrictions and requirements.

Exclusion Criteria

Subjects are not allowed to participate in the study if any of the following
exclusion criteria apply:
1. Clinically relevant abnormal history or presence of physical and mental
health as determined by medical history taking and physical examinations
obtained during the screening visit and/or at the start of the first study day
(as judged by the investigator);
2. Clinically relevant abnormal laboratory results, ECG and vital signs at
screening and/or at the start of the first study day (as judged by the
investigator);
3. Acute disease state (e.g. nausea, vomiting, fever, or diarrhea) within 7
days before the first study day;
4. Abnormal renal function (eGFR (MDRD) < 60 mL/min/1.73m2);
5. Positive test for hepatitis B, C or HIV at screening;
6. 6. History of alcoholism or substance abuse within three years prior to
screening or current use of more than 21 units alcohol per week or drug abuse;
7. Subjects using, on average, more than 3 units of alcohol per day, and unable
to refrain from alcohol use from 24 hours prior to screening, each study day
and whilst in study unit;
8. Subjects smoking, on average, more than 5 cigarettes per day, and unable to
refrain from smoking during the study days;
9. Positive drug- (i.e. positive for cocaine, opioids, amphetamines, opiates,
cannabinoids, benzodiazepines, and/or methadone) or alcohol test at screening
and/or first study day;
10. Inability to refrain from the use of concomitant (prescription and over the
counter) medication which, in the opinion of the investigator, interferes with
their ability to participate in the trial, from one week (or less than 5
half-lives (whichever is longer) prior to the first the first study day until
the last study day;
11. Use of any dietary supplements within 7 days of study drug administration,
or less than 5 half-lives (whichever is longer). Exceptions can be made as
judged by the investigator;
12. A history of severe allergies, or has had an anaphylactic reaction or
significant intolerability (hypersensitivity) to prescription or
non-prescription drugs or food;
13. Hypersensitive (allergic) to cysteamine (mercaptamine) or any of the other
ingredients, e.g. to penicillamine;
14. History or clinical evidence of any disease and/or existence of any
surgical or medical condition which might interfere with the absorption,
distribution, metabolism or excretion of the study drug;
15. Participation in an investigational drug study within 90 days prior to
screening or more than 4 times a year;
16. Loss or donation of blood over 500 mL within 90 days prior to screening or
intention to donate blood or blood products during the study;
17. Inadequate venous accessibility as judged by the physician or nurse;
18. Any known factor, condition, or disease or any reason that might interfere
in the opinion of the medical responsible person with the well-being of the
subject, treatment compliance, study conduct or interpretation of the results.