臨床研究等提出・公開システム

SK-5307 Phase I (multiple-dose study in healthy adult male subjects)

SK-5307 P I multiple-dose study

12

Healthy Japanese adult males: 12 subjects Age: 28.1+-5.1 years Body weight: 63.64+-3.80 kg BMI: 21.33+-1.69 kg/m2 (mean+-SD)

Open-label, two-arm two-period crossover study on repeated oral doses of SK-5307 administered before or after a meal Number of participants: Subjects who underwent the screening test: 38 Subjects deemed eligible for the study inclusion: 18 Period I: 12 subjects Completed: 12 (Discontinuation: 0, Dropout: 0) One subject withdrew from the study before the beginning of Period II Period II: 11 subjects Completed: 11 (Discontinuation: 0, Dropout: 0)

One adverse event was observed in one of 11 subjects after the postprandial administration. The event was judged to be related to the investigational drug. Three adverse events were observed in 3 of 12 subjects after the preprandial administration.

Safety: No deaths, serious adverse events or significant adverse events were observed. In addition, there were no clinically significant findings or changes in vital signs or resting 12-lead EGC. Pharmacodynamics: After repeated administration of SK-5307 for 7 days, the serum IGF-1 concentration on Day 7 was lower than that before administration.

The repeated administration of SK-5307 after or before a meal for 7 days showed no safety concerns and profiles regarding pharmacokinetic and pharmacodynamic evaluation were obtained.

Dec. 15, 2023

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2071220064

Asano Kenji

Sanwa Kagaku Kenkyusho Co.,Ltd.

35, Higashi Sotobori-cho, Higashi-ku, Nagoya City, Aichi Prefecture

clinicaltrials@ml.skk-net.com

Asano Kenji

Sanwa Kagaku Kenkyusho Co.,Ltd.

35, Higashi Sotobori-cho, Higashi-ku, Nagoya City, Aichi Prefecture

+81-52-951-8130

clinicaltrials@ml.skk-net.com

Complete

Oct. 28, 2022

Interventional

randomized controlled trial

open(masking not used)

uncontrolled control

crossover assignment

other

1. Subjects aged 18 years or older but less than 40 years (at the time of informed consent)
2. Subjects whose BMI (weight (kg)/[height (m)]2) is between 18.5 and 25.0 (at the time of screening test)
3. Subjects considered eligible for this study based on the results of screening examination by the investigator or sub-investigator.
4. Subjects who have the capacity to consent and whose written consent has been obtained from the subject

1. Subjects with current medical history.
2. Subjects with a history of liver disease, renal disease, cardiovascular disease, hematological disease, endocrine system disease, digestive system disease, respiratory system disease, psychiatric or cranial nerve disease (including epilepsy), infectious disease that the investigator or sub-investigator judges to affect the safety of the subject or the evaluation of the investigational drug.
3. Subjects with clinically abnormalities in the screening or rest on the day of admission of 12-lead electrocardiogram in period I.
4. Subjects with a complication or a history of drug dependence or alcohol dependence.
5. Subjects with a complication or a history of drug hypersensitivity.
6. Subjects with a complication or a history of food allergy.
7. Subjects who had an average of 20 grams or more of alcohol per day.
8. Subjects who used any drug or supplement within 2 weeks prior to hospitalization in period I.
9. Subjects who had food or beverages containing grapefruit (juice or pulp) within 3 days prior to prior to hospitalization in period I.
10. Subjects who had ingested food or beverages containing St. John's wort (St. John's wort) within 1 week prior to hospitalization in period I.
11. Subjects who have donated 400 mL whole blood within 12 weeks prior to hospitalization in the first stage, 200 mL whole blood within 4 weeks, or blood component(plasma component, platelet component) within 2 weeks.
12. Subjects who had a positive result for HIV antigen/antibody, HBs antigen, or HCV antibody, or a positive reaction to syphilis serology or urine drug test at screening.
13. Subjects with a positive for SARS-CoV-2 nucleic acid amplification test on the day of admission.
14. Subjects with symptoms of suspected COVID-19 (novel coronavirus infection).
15. Subject who is in the opinion of the investigator or sub-investigator, unsuitable in any other way to participate in this study.

Male

Healthy adult subjects

Repeated oral administration of SK-5307 for 7 days.
(2 groups x 2 periods, open-label crossover method)

Safety, Pharmacokinetics, Pharmacodynamics

+81-92-283-7701

Oct. 27, 2022

none