Single-dose Trial of Enteric-coated Cysteamine Bitartrate Capsules in Healthy Adults

JRCT ID: jRCTs031240346

Registered date:20/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Cystinosis
• Date of first enrollment: 20/09/2024
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Single dose of enteric-coated cysteamine bitartrate capsules

Outcome(s)

• Primary Outcome: Pharmacokinetic parameters of cysteamine [AUC (area under the plasma drug concentration-time curve), CL/F (apparent clearance), Vd/F (apparent volume of distribution), ka (absorption rate constant), kel (disappearance rate constant) etc.)] are calculated.
• Secondary Outcome: The difference in nausea (vomiting) between the period after administration of the investigational drug and the period after administration of the control drug. Nausea (vomiting) will be evaluated using the Numerical Rating Scale (NRS: 0 = no nausea (vomiting) at all to 5 = the most severe nausea (vomiting) imaginable).

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Japanese who are 18 years or older at the time of obtaining consent.
2. Individuals who weigh more than 50 kg.
3. Individuals who have no clinically significant abnormalities in clinical test results or medical history at the time of screening.
4. Individuals who can sign the informed consent form (ICF) and comply with the requirements and restrictions described in the ICF and the study protocol.

Exclude criteria

1. Subjects with significant and clinically relevant comorbidities or histories of metabolic endocrine, liver, kidney, blood, cardiovascular, gastrointestinal, urinary, immune, neurological, and psychiatric diseases, as judged inappropriate for this study by the principal investigator or sub-investigator.
2. Subjects with a history of abdominal surgery that may affect drug absorption (excluding appendectomy).
3. Subjects with chronic constipation, fecal impaction tendency, or diarrhea.
4. Subjects with a history of peptic ulcer.
5. Subjects with hypersensitivity or allergy (or suspected) to Cystagon capsules and penicillamine, or a history of such conditions.
6. Subjects with hypersensitivity or allergy (or suspected) to Eudragit L100 or polyethylene glycol (PEG) 6000, or a history of such conditions.
7. Subjects who are pregnant or may be pregnant.
8. Subjects who are breastfeeding.
9. Subjects deemed inappropriate for participation in this clinical trial by the principal investigator or sub-investigator.

Related Information

• Primary Sponsor: Katagiri Daisuke
• Source(s) of Monetary Support: International Medical Research and Development Fund, Project Number 24A1012, Fiscal Years 2024-2026