Single-dose study of OMD-001 in healthy adult volunteers

JRCT ID: jRCT2071200085

Registered date:20/01/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Adult T-cell Leukemia-Lymphoma
• Date of first enrollment: 20/01/2021
• Target sample size: 8
• Study type: Interventional

Intervention(s)

Administration of investigational drug (5- aminolevulinic acid)
10mg/kg Single-dose , Oral

Outcome(s)

• Primary Outcome: Pharmacokinetics and Safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 45age old
• Gender: Male

Include criteria

1) Subjects who signed the written informed consent
2) Male
3) Age>=20 and =<45 at time of consent
4) Body mass index (BMI) >=18.5 and <25.0

Exclude criteria

1) History of any significant drug allergy.
2) History of drug and/or alcohol abuse
3) History of renal, hepatic, cardiovascular, metabolic, respiratory disease.
4) A positive infection test and/or urine drug screen for substance of abuse at screening.
5) Subjects having taken an following drug and/or food.
- Prescription and over-the-counter drugs : within the 14 days prior to the administration of investigational drug.
- The following drugs known to cause photosensitivity : within the 14 days prior to the administration of investigational drug.
Tetracycline antibiotics, sulfonamides, new quinolone antibacterial agents, hypericin (Hypericum erectum extract)
- Supplements containing 5-aminolevulinic acid : within the 14 days prior to the administration of investigational drug.
- Foods containing St. John's Wort (St. John's Wort) : within the 14 days prior to the administration of investigational drug.
- Consumption of alcohol: within the 3 days prior to the administration of investigational drug.
6) Subjects who participated in other clinical trials within 16 weeks prior to the administration of investigational drug.
7) Subjects who received 200 mL of blood (donated blood, etc.) within 4 weeks, 400 mL within 12 weeks, or 1200 mL or more within 1 year prior to the administration of investigational drug. and those who donated blood components within 2 weeks.
8) body weight : < 50 kg
9) Subjects who scheduled to visit another hospital during the clinical trial period
10) Subjects who had Clinically significant abnormality at screening phase and judged by the investigator to be unhealthy
11) Subjects who are judged by the investigator to be inappropriate for conducting this clinical study safely.

Related Information

• Primary Sponsor: Murakami Harumi