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

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

8

Healty adult male (Japanese) Mean Age (SD) years : 28.5 (8.09) years Mean Weigt (SD) kg : 59.50 (6.967) kg Mean BMI (SD) kg/m2 : 21.11 (1.547) kg/m2

Of the 23 subjects who received written consent, 8 subjects were enrolled in this study and were treated with OMD-001, excluding 15 screen-failers (subjects who did not receive the study drug after obtaining consent). The study was completed in all treated subjects, and none were discontinued.

Mild nausea was noted in 2 of 8 cases (25%). Both were judged adverse reaction(ADR).

Plasma 5-ALA increased rapidly after OMD-001 administration, reached Cmax at 0.50 hours (median), then disappeared rapidly, and decreased to below the lower limit of quantification in all subjects 12 hours after administration. Plasma PpIX reached Cmax 4.00 hours (median) after administration, and then decreased to below the lower limit of quantification in all subjects 48 hours after administration. Plasma PpIX Tmax and T1 / 2, z were all longer than 5-ALA, and 5-ALA was rapidly converted to PpIX. The mean value of intracellular PpIX in peripheral blood mononuclear cells reached the maximum 2 hours after administration, and decreased to less than the lower limit of quantification in all subjects 24 hours after administration. After that, it remained below the lower limit of quantification or at an extremely low value.

The safety and tolerability of a single oral administration of OMD-001 10 mg / kg to healthy adult males were confirmed, and no notable problems were found in the PK profile.

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2071200085

Murakami Harumi

Souseikai Sumida Hospital

1-29-1, Honjo, Sumida-ku, TOKYO 130-0004, JAPAN

harumi-murakami@lta-med.com

Haraguchi Mikiko

Otsuka Medical Device Co., Ltd.

2-2, Kanda-Tsukasamachi, Chiyoda-ku, Tokyo , Japan

+81-3-6361-7459

OtsukaRegistry-CT@otsuka.jp

Complete

Jan. 19, 2021

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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

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.

Male

Adult T-cell Leukemia-Lymphoma

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

Pharmacokinetics and Safety

+81-92-283-7701

Jan. 15, 2021

none